Surgery may be appropriate for some patients who have had an unsatisfactory response to conservative management. However it is essential that patients receive specialist assessment to check their suitability for surgery. It is vital that those undergoing surgery have realistic expectations and are aware of potential complications.
There are a number of surgical options for faecal incontinence, these include:
Sphincter Repair - the external anal sphincter can be repaired or simply tightened to try and improve control. The former applies to direct injuries such as those sustained obstetrically or following surgery. An anterior sphincter defect may be repaired some time after the injury. This operation is carried out through a small anterior incision. The divided ends of the external anal sphincter are identified and either approximated or more commonly overlapped. Also known as ‘sphincteroplasty’ or ‘direct sphincter repair’.
Levatorplasty - an alternative approach in patients with no definable sphincter defect is to tighten or to plicate the external anal sphincter (EAS) and pelvic floor muscles (levatorplasty). This involves bringing together the muscles of the pelvic floor above the anal canal. This may be carried out anterior to the anal sphincter or posteriorly. The objective is to lengthen the anal canal and augment an anal sphincter repair if performed at the same time. A post-anal repair is carried out between the internal and external anal sphincters posteriorly and plicates the levator ani muscles, the puborectalis and the external sphincter.
Neosphincter - other operations have been developed to replace the sphincter when repair is not possible or has failed. These include the dynamic graciloplasty (DGP), a gluteoplasty and artificial anal sphincter. In the first, the muscle is taken from the thigh and encircled around the anus. A nerve stimulator is inserted to make the muscle contract tonically. The gluteoplasty transposes one or both gluteus muscle from the buttock and uses them to encircle the anal canal. This can be combined with an electrical stimulator (stimulated gluteoplasty). The artificial anal sphincter is a cuff made of silicone that encircles the anus and contains liquid that is transferred between a reservoir and the cuff. This either opens or closes the anal canal.
Internal anal sphincter repair - attempts have been described to repair a disrupted internal anal sphincter in conjunction with external anal sphincter repair (described above), or as an isolated procedure. Other attempts to treat internal sphincter disruption or weakness have been tried by augmenting bulk into the anal canal using an island advancement flap anoplasty or by injecting biocompatible materials into the IAS to increase its bulk. The application of thermal injury to the anus to effect scarring and improve anal closure is another method that has been reported. The Secca procedure is an example.
Sacral nerve stimulation (SNS) - a recent innovation is sacral nerve stimulation. This technique involves stimulating the sacral nerves S3 or S4. Its main advantage is that a trial period of temporary stimulation (percutaneous nerve evaluation) only involves simple insertion of stimulating wires into the back is possible. If this is successful, the patient can have an implantable stimulator to modulate sacral nerve function.
Irrigation ports - irrigation can be performed through the anus or if unsuccessful, surgically constructed, lavage systems can be considered. One option is to bring the appendix onto the abdominal wall to allow catheters to be inserted into the colon (ACE or Malone operation). Liquids and laxatives can be instilled to wash out the colon. Another more complicated approach is to create a ‘T’ junction with the transverse colon to bring out a loop with a continent valve onto the abdominal wall. Percutaneous endoscopic colostomy (PEC) places an artificial irrigation tube into the colon, usually in the descending (left) colon. The patient then washes out the colon when appropriate. The major problem with PEC is that the device is foreign to the body and sepsis requiring removal is common.
Stoma - a stoma (usually a colostomy) may be considered for severe uncontrolled FI.
7.1. Is surgery effective and does it last compared with no surgery (conservative treatment)?
7.1.1. Introduction
For patients with faecal incontinence refractory to medical treatment, surgery may be an option. As surgical intervention is invasive and carries the risk of complications, it is important to assess the efficacy of surgery, incidence of adverse events and whether results of the operation are sustained over time.
7.1.2. Studies considered for this review
Randomised and non-randomised comparative study designs were considered for inclusion if they compared any surgical intervention for faecal incontinence with no surgery or conservative treatment. Long-term results of surgery were considered important to ascertain whether successful outcomes were maintained.
7.1.3. Clinical evidence
Four RCTs218,289,298,408 (evidence level 1+) and one cohort study403 (evidence level 2+) met the inclusion criteria for this clinical question (evidence table 20, appendix D). Two of the RCTs were cross-over trials218,408.
Levatorplasty or post-anal repair vs anal plug electrostimulation
One study298 with a total of 59 patients with disabling faecal incontinence randomised patients to surgery (anterior levatorplasty for women and post-anal repair for men) (n=31) or anal plug electrostimulation of the pelvic floor (n=28). There was a significant improvement in physical and social handicap at 3, 12 and 24 months follow-up in the surgery group. Although there was a statistically significant number of patients who reported an improvement in incontinence at 3 months in the levatorplasty group, this significance was lost at 12 and 24 months follow-up. None of the other clinical outcomes reported (less use of pads, deferring time, loose and solid stool) reached statistical significance. One case of wound infection was reported in the surgery group and one patient in the electrical stimulation group reported a ‘burning sensation in the vagina’. This study suggests only short-term benefit from surgery to tighten the anal canal and pelvic floor.
Artificial anal sphincter vs supportive care
O’Brien et al289 reported the results of 14 adults with severe faecal incontinence who were randomised to placement of an artificial anal sphincter (Acticon neosphincter) (n=7) or supportive care (n=7). At 6 months follow-up there was a significant difference between groups in the Cleveland Clinic Incontinence Score favouring the artificial anal sphincter group (p=0.002) and in the American medical systems (AMS) quality of life score (p=0.04) favouring the artificial anal sphincter group. Three perioperative complications were reported in the surgical group.
Sacral nerve stimulation: stimulators ‘on’ vs ‘off’
Vaizey et al408 and Leroi et al218 both report results from cross-over studies during which all patients were implanted with a sacral nerve stimulator. All patients had their stimulators turned ‘on’ or ‘off’ for an initial phase of the trial which was immediately followed by a second phase during which the stimulator was turned to the opposite setting. They both had a highly selective study population as only patients that responded positively to the initial trial phase were included. Although the study by Vaizey et al408 only recruited two patients, there was a large magnitude of treatment effect; the median episodes of incontinence (over the two weeks test period) of solid or liquid stool decreased from baseline to when stimulation was turned ‘on’ (12 vs. 1 respectively). Leroi et al218 was a larger trial conducted in 27 patients. In this trial the treatment effect was not so large. The median frequency of FI episodes per week was 0.8 (range 0–11) during the ‘on’ phase compared to 1.9 (range 0–11) during the ‘off’ phase of the trial (p=<0.05).
In the Leroi et al study, even though the median frequency of FI episodes and the Cleveland Clinic Incontinence Score were both significantly reduced when the active ‘on’ period was compared to the ‘off” period; this difference was small compared with the reduction observed between the on period and the baseline period. One explanation could be that there is a substantial placebo response associated with SNS, in which case the results of SNS case series should be treated with scepticism. However, there was a significant increase in sphincter pressures in the treated group and interestingly, this increase was maintained during the ‘off’ period of the trial. The results of both these studies218,408 could be due to ‘contamination’: during the off period patients were still benefiting from having the device switched on in the previous period and therefore the treatment effect is diluted. The suggestion is that SNS has a beneficial effect on nerve function that is prolonged for some time after stimulation has ceased.
Dynamic graciloplasty vs no surgery
Tillen et al403 conducted a cohort study, reported within an NHS HTA report. A group of 48 patients with stomas or refractory FI who underwent DGP were compared with a group of 40 patients not offered surgery (standard care). At 24 months there was a significantly greater change in the mean Cleveland Clinic Incontinence Score (p=0.001), depression scale (p=0.05) and lifestyle scale (p<0.0001) in favour of the surgery group however, this group also reported high numbers of evacuation difficulties/pain (n=33), infections (n=31) and circulatory problems (n=23).
7.1.4. Cost-effectiveness evidence
We found four economic studies that compared surgery for faecal incontinence with conservative management. Three were evaluating different types of surgery for patients with severe intractable FI and one evaluated implantation of a neuroprosthesis for patients with spinal cord injury (evidence table 35, appendix D).
A Dutch study evaluated a case series of 43 patients undergoing DGP for severe intractable FI3. They measured the costs and quality of life before and after surgery. Before surgery patients were being conservatively managed with ‘diapers, enemas, tissues, and diets’. Costs and quality of life were observed up to 12 months post-surgery and were projected 29 years into the future. They found that DGP improved quality of life (by various measures) but was more costly (£19,800 vs £7,600) than conservative management. It is difficult to say whether DGP is cost-effective compared with conservative management because health outcomes were not measured in QALYs and were based on before-after comparisons.
A detailed model was developed for an NHS HTA report403 using a cohort study of 48 patients undergoing DGP and another 40 patients with refractory FI or stoma who had not been referred for DGP (see clinical evidence above). Costs and quality of life were observed up to 48 months post-surgery and were projected 21 years into the future. The changes over 12 months in the EQ-5D – the quality of life instrument used to calculate QALYs – (+4% vs −1%) were not statistically significant, although other measures of quality of life were significant. In their base case analysis the authors found that DGP cost £40,000 per QALY gained compared with conservative management (‘incontinence pads, prescriptions, some inpatient and outpatient care and community health services’), which is above our threshold of £30,000 per QALY gained. However, when they used costs from three other specialist NHS centres (rather than the Royal London Hospital where the cohort study was based), the ratio fell to £29,000 per QALY gained. The results of the model are highly contingent on the assumptions used to project the results in to the future, such as the constant failure rate for DGP and the rate of conversion to stoma for patients who are conservatively managed. In patients with a shorter life expectancy than the base case (25 years), DGP will be less cost-effective, because there is less time to offset the surgical costs with longer term cost savings.
Both of the above studies3,403 additionally compared stoma formation (and aftercare) with conservative management. In both cases, stoma formation was considerably more costly than conservative management (£2,100 vs £400 per year403). Neither study presented evidence on the health gain associated with stoma formation, although each suggested that the improvement in quality of life was minimal.
The third study162, a simple model based on two cohorts (n=49), compared both sacral nerve stimulation and anal sphincter repair with conservative management for patients with incapacitating FI due to a variety of causes. Surgery was more costly than conservative management, although there was no statistical analysis and no estimate of health gain.
The fourth study83 presented a case series of 17 patients with supra-sacral spinal cord injury in the USA. They found that neuro-prosthesis was cost saving after 5 years compared with conventional care. In addition to the small sample size and poor study design, the usefulness of this study is limited because:
It was not subjected to statistical or sensitivity analysis, and
Care pathways and costs are likely to be different in this US setting compared with the NHS. Moreover these results are only applicable to patients with major spinal injury and are therefore not applicable to the majority of patients with incapacitating FI.
7.1.5. Conclusions
The results of the Osterberg et al298 study show that levatorplasty yielded better early results than anal plug electrostimulation of the pelvic floor, but this effect was lost by 1 year follow up. One comparative study was in favour of the artificial anal sphincter over supportive care 289. The Tillin et al403 study showed that patients having DGP had a significant improvement in continence scores compared with the group without surgery.
DGP is borderline cost-effective compared with conservative management for patients with severe intractable FI and a reasonably long life expectancy. Stoma formation with aftercare and other forms of surgery are costly compared with conservative management but there is no evidence regarding their cost-effectiveness.
The recommendations on surgical management are in section 7.7.
7.2. Are any surgical interventions more effective than others?
7.2.1. Introduction
Several different surgical approaches may be possible for an individual patient. It is useful to compare, therefore, not only how effective surgery is for faecal incontinence, but how well each type of surgery performs in a given scenario compared with a different surgical intervention. For example, patients with anal sphincter disruption could be eligible for overlapping or end-to-end sphincter repair or sacral nerve stimulation (SNS). Injection of bulking agents is also a possible management option in these patients. Patients with weak but intact sphincters could have a post anal repair, pelvic floor plication (levatorplasty), a total pelvic floor repair, bulking agents, or SNS. Secondary procedures for failed primary interventions include repeat sphincter repair, artificial anal sphincter, dynamic graciloplasty and sacral nerve stimulation.
7.2.2. Studies considered for this review
Randomised and non-randomised comparative study designs were considered for inclusion if they compared one surgical intervention for faecal incontinence with another surgical intervention in adult patients with faecal incontinence.
7.2.3. Clinical evidence
Four RCTs92,306,411,440 (evidence level 1+) and two non-randomised controlled trials346,395 (evidence level 2+) met the inclusion criteria for this clinical question (evidence table 21, appendix D). One of the non-randomised controlled trials was a matched control trial 346 while the second was a non-randomised controlled trial395.
Post-anal repair vs levatorplasty vs total pelvic floor repair
One study306 with a total of 36 female participants with faecal incontinence related to pundendal neuropathy and a history of obstetric trauma randomised participants to post-anal repair (n=12), anterior levatorplasty (n=12) or total pelvic floor repair (n=12) groups. This study with a follow-up period of 24 months reported that quality of continence, frequency of continence per month, continence score after total pelvic floor repair was significantly better than for post-anal repair and anterior levatorplasty.
Post-anal repair vs total pelvic floor repair
A study by van Tets et al411 randomised 20 female patients to either post-anal repair (n=11) or total pelvic floor repair (n=9) groups. No significant differences were found between clinical, manometric and radiologic outcomes between the groups at the follow-up at 42 months.
Total pelvic floor repair vs total pelvic floor repair with plication
In a study by Deen et al92 33 female patients with FI related to pudendal neuropathy, patients were randomised to total pelvic floor repair (n=18) or total pelvic floor repair and plication of the internal anal sphincter (n=15). There was no significant difference in continence scores. There was a significant difference in maximum resting pressures in favour of total pelvic floor repair compared to total pelvic floor repair with plication.
Total pelvic floor repair vs gluteoplasty
The final RCT440 reported results from 24 women with post-obstetric faecal incontinence who were randomised into total pelvic floor repair (n=12) or gluteoplasty groups (n=12). At a median follow-up of 10 months no significant differences were found in continence scores, manometry or adverse effects between the two groups.
Dynamic graciloplasty: one step vs two step
Rongen et al346 conducted a matched control study to compare the effectiveness of one vs. two step dynamic graciloplasty for 26 patients with faecal incontinence. The one step procedure involved the muscle wrap and the implant of the electrodes and implanted pulse generator (IPG) in one operation. The two-step procedure received the implant in a separate operation 6 weeks after the muscle transposition. Although there was a difference between the faecal incontinence, morbidity and quality of life outcomes, there were not significant. The results of the trial suggest that a one-step procedure is feasible and will avoid the extra admission and secondary procedure of a two step approach.
Sphincter repair: perineal approach vs posterior fourchette approach
A non-randomised controlled trial395 reported results at a mean of 22 months for 50 women with sphincter injuries who underwent anterior overlap sphincter repair. The first 32 underwent surgery by the perineal approach and the subsequent patients by the posterior vaginal fourchette approach. Both groups had significantly improved continence scores after surgery, but these postoperative scores were not significantly different between the groups. There was significantly more wound complications from perineal compared to the posterior fourchette approach.
7.2.4. Cost-effectiveness evidence
We found four economic studies that compared different types of surgery for faecal incontinence (evidence table 35, appendix D).
The first study45 was a case series of 75 patients with severe FI undergoing surgery. The authors found that total pelvic floor repair improved continence and reduced costs compared with post-anal repair (£2,200 vs £2,700). There were a number of limitations; not least there was no statistical analysis and the follow-up periods differed between the groups.
A Dutch study compared a case series of 43 patients undergoing dynamic graciloplasty (DGP) with seven patients undergoing stoma formation. This study was described in 7.1.4. The authors found that DGP was cost-saving compared with stoma formation (£19,800 vs £44,700). This study has been criticised for inflating the cost of stoma care55,403, which was based on only seven patients.
A detailed model was developed for an NHS HTA report403 and has also been described in 7.1.4 above. They found that DGP was dominant (cost saving and quality of life improving) compared with stoma formation for patients being conservatively managed at the outset. For patients already receiving stoma care at the outset, the conversion to DGP was not cost saving but it was cost-effective (between £5,000 and £15,000 per QALY gained). As noted in 7.1.4, in patients with a life expectancy less than that assumed in the model (25 years), DGP will be less cost-effective, because there is less time to offset the surgical costs with longer term cost savings.
The fourth study162, a simple model described above (7.1.4). Sacral nerve stimulation was substantially more costly than sphincter repair (£14,800 vs £3,600) but, using data from the Dutch study above, substantially less costly than DGP (£21,000) or stoma formation (£22,000), although statistical analysis was not conducted.
7.2.5. Conclusions
Although Oya et al306 showed that total pelvic floor repair is more effective in improving faecal incontinence than post-anal repair or anterior levatorplasty, it is currently rarely performed in clinical practice.
Deen et al94 found that total pelvic floor repair significantly improved the continence scores compared to levatorplasty and post-anal repair.
However, van Tets et al411 found no significant difference between total pelvic floor repair and post-anal repair. Another study92 found no significant difference between total pelvic floor repair with and without plication of the internal anal sphincter. Yoshioka et al440 found no significant differences between total pelvic floor repair and gluteus transposition.
The non randomised controlled trial395 found that sphincter repair by the perineal approach had significantly more wound complications than the posterior fourchette approach.
Dynamic graciloplasty is cost-effective compared with stoma care, except in patients with a short life expectancy. The trial by Rongen et al346 suggests that a one-step procedure should be standard practice as opposed to a two-step procedure.
The recommendations on surgical management are in section 7.7.
7.3. Do any interventions, pre or post surgery, affect the outcome of surgery for FI?
7.3.1. Introduction
This review was conducted to evaluate if any pre or post operative conservative interventions would optimise the outcomes of surgery. Interventions pre/post surgery may alter stool consistency, optimise muscle function or promote optimal healing. Examples of interventions are medications, exercises, bowel retraining, biofeedback, diet, bowel management in the pre or post-operative period or a covering stoma.
7.3.2. Studies considered for this review
Randomised and non-randomised comparative study designs which compared the effectiveness of an additional conservative therapy (pre or post surgery) or surgical adjuncts compared with surgery alone at managing faecal incontinence. Studies conducted in adult patients with faecal incontinence were selected.
7.3.3. Clinical evidence
Three studies91,159,272 met the inclusion criteria for this clinical question (evidence table 22, appendix D, evidence level 1+).
Sphincter repair vs sphincter repair and biofeedback
One study91 with a total of 31 female participants with an external anal sphincter defect and faecal incontinence for at least 12 months randomised patients to either sphincter surgery (sphincter repair and levatorplasty) (n=17) or sphincter surgery plus biofeedback which commenced three months post surgery (n=14). This study with a follow-up period of 9 months reports comparisons between groups at 3 and 12 months after surgery which are not statistically significantly different in any of the functional or physiological variables.
Sphincter repair and medical bowel confinement vs sphincter repair plus regular diet
One study272 reported results in 32 adult patients with faecal incontinence undergoing anal sphincter repair. Patients were randomised to receive either sphincter repair plus medical bowel confinement (n=17) which consisted of a clear liquid diet and loperamide and codeine phosphate until the third post-operative day or to receive sphincter repair plus regular diet beginning the day of the surgery (n=15). There was no statistical difference in the mean change of continence score from pre to postoperatively between the two groups. There was a significant difference between the groups in the first post-op bowel movement 3.9 mean days in the medical bowel confinement group vs. 2.8 in the regular diet group (p=0.05). The authors reported no significant difference in complications between the groups but the sample was too small for detecting such differences.
Sphincter repair with defunctioning stoma vs sphincter repair without a stoma
One study 159 randomised 27 patients with faecal incontinence requiring sphincter repair to additional defunctioning stoma (n=13) or no stoma (n=14). There was no significant difference between groups in any of the outcomes measured, for example, the Cleveland Clinic Incontinence Score, complications, and hospital stay at a mean follow-up period of 34 months.
7.3.4. Cost-effectiveness evidence
We found one relevant economic study for this question (evidence table 35, appendix D).
This study272 mentioned in the clinical review above, was based on an RCT of 54 patients undergoing surgery for intractable FI. It evaluated immediate post-surgical feeding with normal diet versus post-surgical bowel confinement. They found no significant difference in either hospital charges (£8,000 vs £6,800) or complications but the sample was small for detecting such differences.
7.3.5. Conclusions
In the Nessim et al study272 there was no significant differences between the sphincter repair plus medical bowel confinement group and sphincter repair plus regular diet groups.
Evidence from the Davis et al study91 does not suggest that surgery plus post-operative biofeedback is more effective at managing faecal incontinence as compared with surgery alone. Results from the Hasegawa et al study159 do not show any significant differences between having a defunctioning stoma and not having a stoma during sphincter repair.
The recommendations on surgical management are in section 7.7.
7.4. Systematic review of case series
7.4.1. Introduction
We undertook a systematic review of surgical case series for the treatment of faecal incontinence for the following reasons:
a small number of RCTs and non-randomised comparative trials were retrieved for the clinical questions on surgery
many of retrieved comparative studies were conducted in small patient groups
most of the retrieved comparative studies investigated the effectiveness of surgical interventions which are rarely performed
most of the retrieved comparative studies did not provide long-term results.
Case series, by definition, do not have a control group and therefore have to be interpreted with caution since observed outcomes could be attributable (partly or wholly) to a placebo response or to a regression to the mean effect, as well as to a real treatment response. The GDG considered this evidence with these issues in mind.
7.4.2. Inclusion criteria and methods
Due to the limitations of case series discussed above, the following inclusion criteria was agreed:
reported results on sphincter repair, repeat sphincter repair, antegrade irrigation, levatorplasty, post-anal repair, total pelvic floor repair, bioinjectables/sphincter bulking agents, island advancement flap anoplasty, sacral nerve stimulation, dynamic graciloplasty, gluteoplasty, artificial anal sphincter +/− any conservative intervention
reported results from at least ten truly consecutive patients with faecal incontinence
In addition to standard data extraction, patients were categorised as ‘cured’, ‘improved’ or ‘not improved’ and proportions calculated. ‘Cured’ was defined as attainment of complete continence to solid, liquid and gas. ‘Improved’ was defined as an improvement of symptoms. In studies which did not distinguish between proportion of patients that were ‘cured’ and ‘improved’, the category ‘improvement of symptoms’ may include patients that were ‘cured’. The category ‘Not improved’ included patients whose symptoms remained the same or worsened following surgery. These categories were also divided into two groups depending on whether the outcomes were reported by clinicians or patients. The GDG acknowledged that clinician-reported outcomes and patient-reported outcomes after surgery may differ; therefore both types of outcomes were recorded, and considered separately. When studies reported incontinence scores from patient’s feedback this was considered to be a patient-reported outcome. However, if scores were determined from patient’s case notes this was considered to be a clinician-reported outcome. We pooled the results of the case series by way of a fixed effects meta-analysis, which used a Freeman-Tukey arcsine transformation to stabilise the variances of the individual study proportions254. As with most statistical analyses, the resulting confidence intervals reflect only uncertainty due to sample variability and not uncertainty due to study design, methodological rigour, etc. The pooled rates of ‘cured’, ‘improved’ or ‘not improved’ faecal incontinence were calculated to the nearest per cent for each surgical intervention using the number of patients in the study at time of follow-up. Frequently studies did not report outcomes amenable to all the categories used. Therefore the three rates combined often do not total 100% for a particular study. Some studies did not report outcomes amenable to any of these categories. Percentages of complications were also recorded.
7.4.3. Sphincter Repair
29 case series15,24,38,39,58,111,113–115,129,130,143,145,146,152,187,194,221,231,261,293,299,351,357,377,385,397,441,444 with a total of 1379 subjects met the inclusion criteria (evidence table 23, appendix D, evidence level 3). There is also a summary results table for case series by surgery type in section 7.4.15.
The weighted mean percentages calculated from the clinician-reported outcomes are as follows; 40% (95% CI, 15% to 65%) of patients’ reported no faecal incontinence symptoms (‘cured’), 47% (95% CI, 22% to 72%) of patients symptoms were ‘improved’ and 13% of patients symptoms were ‘not improved’(95% CI, 4% to 30%).
The weighted mean percentages calculated from the patient-reported outcomes are as follows; 27% (95% CI, 23% to 31%) of patients reported being ‘cured’, 52% (95% CI, 49% to 55%) ‘improved’ and 36% (95% CI, 33% to 39%) had ‘not improved’ after surgery.
Wound complications were reported in 10% (95% CI, 8% to 12%) of patients, 3% (95% CI, 1% to 5%) of patients had bleeding complications and 12% (95% CI, 9% to 14%) had unknown or other complications from the surgery (summary results table 1, appendix E).
7.4.4. Repeat sphincter repair
Two studies316,410 with a total of 46 patients met our inclusion criteria for repeat sphincter repair (evidence table 24, appendix D, evidence level 3).
The weighted mean percentages calculated from the patient-reported outcomes are as follows; 63% (95% CI, 49% to 76%) of patients reported that their faecal incontinence symptoms had ‘improved’ after surgery while 37% (95% CI, 24% to 51%) reported ‘no improvement’.
No complications from surgery were reported but in one study316,410 two patients underwent further surgery for faecal incontinence (summary results table 2, appendix E).
7.4.5. Levatorplasty
Two studies6,299 reported results from 76 patients undergoing levatorplasty, both describing anterior levatorplasty (evidence table 26, appendix D, evidence level 3). One of these studies retrieved6 combined anterior levatorplasty with external anal sphincter plication.
When the results from these studies were combined, 22% (95% CI, 11% to 35%) of patients reported a ‘cured’ outcome, 63% (95% CI, 49% to 77%) reported ‘improved’ symptoms while 6% (95% CI, 2% to 14%) of patients were reported by their clinicians not to have improved.
Six per cent (95% CI, 2% to 14%) of patients had wound infections. No other complications were reported (summary results table 3, appendix E).
7.4.6. Total pelvic floor repair
Only one study202 assessed the affects of total pelvic floor repair surgery (evidence table 27, appendix D, evidence level 3). Of the 57 patients available at follow-up, clinicians reported 70% (95% CI, 58% to 82%) had improved while 30% (95% CI, 18% to 42%) had not improved. Complications were not reported (summary results table 5, appendix E).
7.4.7. Post-anal repair
Six studies2,116,238,295,330,370 with a total of 128 patients at follow-up reported results after post-anal repair surgery (evidence table 25, appendix D, evidence level 3).
Combined clinician-reported outcomes resulted in 35% (95% CI, 14% to 56%) of patients being ‘cured’ and 65% (95% CI, 44% to 86%) ‘improved’. Fourteen per cent (95% CI, 9% to 21%) of patient-reported they had been cured following surgery, 45% (95% CI, 37% to 52%) improved and 43% (95% CI, 35% to 51%) not improved.
Six per cent (95% CI, 2% to 12%) of patients had wound infections and a further 4% (95% CI, 1% to 10%) had other complications (summary results table 4, appendix E).
7.4.8. Dynamic Graciloplasty
Nine studies65,69,120,227,311,375,402,421
347 reported results for patients undergoing dynamic graciloplasty (evidence table 29, appendix D, evidence level 3) with a total of 559 patients.
Clinicians reported that 33% (95% CI, 13% to 53%) of the patients were ‘cured’ following surgery, 56% (95% CI, 44% to 68%)had ‘improved’ while 45% (95% CI, 32% to 58%)’ not improved’. The patient-reported outcomes are as follows: 30% (95% CI, 18% to 44%)of patients reported that they were ‘cured’, 73% (95% CI, 67% to 78%)felt they were ‘improved’ while 17% (95% CI, 7% to 29%)reported that they had ‘not improved’ following the dynamic graciloplasty. Major wound complications were reported in 37% (95% CI, 31% to 44%), minor wound complications in 22% (95% CI, 18% to 25%)and device/stimulation problems in 38% (95% CI, 34% to 43%)of patients (summary results table 9, appendix E).
7.4.9. Gluteoplasty
One study227 reported results for dynamic gluteoplasty in 11 patients who were followed-up for 24 months (evidence table 30, appendix D, evidence level 3). Forty-five per cent (95% CI, 16% to 74%) of patients reported that they had ‘improved’ episodes of faecal incontinence after surgery while 55% (95% CI, 26% to 84%) of patients had ‘not improved’.
Major wounds complications were reported in 36% (95% CI, 8% to 64%) of the patients, 18% (95% CI, 5% to 41%) had minor wound complications and 45% (95% CI, 16% to 74%) had problems with their device or stimulation problems (summary results table 10, appendix E).
7.4.10. Artificial anal sphincter
14 case series9,51,66,104,127,210–212,214,251,296,309,361,432,436 were found in which 402 patients underwent implantation of an artificial anal sphincter (evidence table 31, appendix D, evidence level 3). Of the five studies which reported changes in continence outcomes, clinicians reported that 38% (95% CI, 12% to 64%) were ‘cured’, 87% (95% CI, 76% to 95%) of patients had ‘improved’ and 31% (95% CI, 6% to 56%) had ‘not improved’. Two studies reported that 79% (95% CI, 65% to 90%) of patients reported having ‘improved’ symptoms. However, it should be noted that in the remaining nine studies continence outcomes were not reported.
There was a high complication rate for this procedure; twenty per cent (95% CI, 13% to 27%) of patients had complications associated with wound infection, while 50% (95% CI, 44% to 55%) had other complications (summary results table 11, appendix E).
7.4.11. Island advancement flap anoplasty
One study260 reported a case series of 15 patients who had undergone island advancement flap anoplasty to repair the internal sphincter (evidence table 34, appendix D, evidence level 3).
No results were reported that indicated the proportion of patients cured, improved or not improved. Twenty per cent (95% CI, 0% to 40%) of patients had a wound infection following surgery (summary results table 7, appendix E).
7.4.12. Bioinjectables/sphincter bulking agents
Three studies90,371,372 reported on 40 patients that underwent treatment with bioinjectables to manage faecal incontinence (Evidence Table 33, Appendix D, evidence level 3). Two studies reported clinician rated continence outcomes. 87% (95% CI, 72% to 97%) of patients were reported to be ‘cured’ and 36% (95% CI, 8% to 64%) of patients had ‘improved’. Thirty-three per cent (95% CI, 9% to 57%) of patients had unspecified complications (summary results table 6, appendix E).
7.4.13. Radio frequency energy (secca procedure)
One study394 reported on ten patients that underwent the SECCA procedure of radio-frequency energy (evidence table 32, appendix D, evidence level 3). No continence or complication data appropriate for the weighted mean proportions was reported.
7.4.14. Sacral Nerve Stimulation
Eight studies138,140,183,184,198,242,348,405 were identified for sacral nerve stimulation surgery (evidence table 28, appendix D, evidence level 3). One hundred and fifty-seven patients were assessed by a clinician for changes in faecal incontinence symptoms after surgery. Seventy- eight per cent (95% CI, 70% to 85%) of patients had ‘improved’ and twenty-four per cent (95% CI, 13% to 35%) of patients had ‘not improved’. No results were reported for ‘cured’ patients following surgery. Six per cent (95% CI, 3% to 11%) of patients suffered wound infection, with 18% (95% CI, 13% to 24%) of patients undergoing other complications (summary results table 8, appendix E).
7.4.15. Summary results table for case series by surgery type
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| Surgery type | Number of case series | Weighted Mean % (95% CI) |
|---|
| Faecal Incontinence | Complications |
|---|
| Cured | Improved | Not improved | Wound infection | Bleeding | Unknown or other |
|---|
| CR | PR | CR | PR | CR | PR |
|---|
| Sphincter Repair | 29 | 40 (15–65) | 27 (23–31) | 47 (22–72) | 52 (49–55) | 13 (4–30) | 36 (33–39) | 10 (8–12) | 3 (1–5) | 12 (9–14) |
| Repeat Sphincter Repair | 2 | NR | NR | NR | 63 (49–76) | NR | 37 (24–51) | NR | NR | NR |
| Levatorplasty | 2 | NR | 22 (11–35) | NR | 63 (49–77) | 6 (2–14) | NR | 6 (2–14) | NR | NR |
| Post-anal Repair | 6 | 35 (14–56) | 14 (9–21) | 65 (44–86) | 45 (37–52) | NR | 43 (35–51) | 6 (2–12) | NR | 4 (1–10) |
| Total Pelvic Floor Repair | 1 | NR | NR | 70 (58–82) | NR | 30 (18–42) | NR | NR | NR | NR |
| Bioinjectables | 3 | 87 (72–97) | NR | 36 (8–64) | NR | NR | NR | NR | NR | 33 (9–57) |
| Island Advancement Flap Anoplasty | 1 | NR | NR | NR | NR | NR | NR | 20 (0–40) | NR | NR |
| Sacral Nerve Stimulation | 8 | NR | NR | 78 (70–85) | NR | 24 (13–35) | NR | 6 (3–11) | NR | 18 (13–24) |
| Graciloplasty | 9 | 33 (13–53) | 30 (18–44) | 56 (44–68) | 73 (67–78) | 45 (32–58) | 17 (7–29) | 37 (31–44) | 22 (18–25) | 38 (34–43) |
| Gluteoplasty | 1 | NR | NR | NR | 45 (16–74) | NR | 55 (26–84) | 36 (8–64) | 18 (5–41) | 45 (16–74) |
| Artificial Bowel Sphincter | 14 | 38 (12–64) | NR | 87 (76–95) | 79 (65–90) | 31 (6–56) | NR | 20 (13–27) | NR | 50 (44–55) |
Key: CR – clinician reported, PR – patient reported, NR – not reported
7.5. Conclusions from surgical case series
The selection process for a particular operation can be difficult. The initial surgical management will depend on the severity of the clinical symptoms and the anatomy of the sphincter as depicted by anal ultrasonography or MRI.
There is no evidence for the direct repair of the internal anal sphincter. Other options may include injections of collagen or biospheres (see section 7.4.12), the Secca procedure (see section 7.4.13) or island flap anoplasty (see section 7.4.11). None of these procedures have been subjected to long-term follow-up and should be considered experimental for the present.
There are a large number of case series of anal sphincter repair involving a total of 1379 patients. Synthesis of this evidence suggests that physician reported outcomes are better than patient-reported outcomes and that there is a deterioration of symptoms over time.
A very small number of case series were found on all other procedures with almost no long term follow-up. Neosphincters are associated with high reported complication rates.
Cost-effectiveness of external sphincter repair surgery
We have not found published evidence concerning the cost-effectiveness of external sphincter repair surgery after unsuccessful conservative management. However, we cautiously conclude that this surgery is cost-effective on the basis of the case series evidence, as follows. It has been shown that dynamic graciloplasty (DGP) is borderline cost-effective compared with conservative management for a different group of patients (section 7.1.4). The case series evidence shows that external sphincter repair and DGP have similar effectiveness rates for their respective patient groups but the former has far fewer complications. With better selection of patients, as recommended in this guideline, we would expect to see even better outcomes for external sphincter repair surgery than observed in the case series evidence. Furthermore external sphincter repair is one of the lowest cost surgical procedures for faecal incontinence162 – around £3000 each in the NHS. Therefore external sphincter repair is likely to be more cost-effective compared with conservative management for appropriately selected patients than is DGP for its patient group.
Cost-effectiveness of sacral nerve stimulation
We have not found published economic evidence concerning sacral nerve stimulation (SNS). However, we cautiously conclude that SNS is cost-effective after unsuccessful conservative management on the basis of the case series evidence, in the same manner as for external sphincter repair surgery above. It has been shown that dynamic graciloplasty (DGP) is borderline cost-effective (section 7.1.4). The case series evidence shows that SNS has a higher effectiveness rate and has fewer complications compared with DGP. Furthermore anecdotal evidence suggests that compared with DGP, SNS is associated with a shorter length of stay – most patients can undergo day surgery - and the costs of the SNS procedure are lower. From a small sample of Trusts we have found the procedural cost of SNS (permanent device) was between £6,500 and £10,500 compared with the £12,000 to £22,000 for DGP reported in the NHS HTA report403. Therefore, it would seem that SNS is likely to be more cost-effective than DGP, assuming that the patient cohorts are broadly similar in the severity of their FI and also assuming that the longer term effectiveness, currently unknown, would also favour SNS.
7.6. Research on patient views
A systematic review of patient views about surgery was undertaken. Three relevant studies were retrieved (evidence table 1, appendix D).
One study184 investigated the effect of SNS on patients’ sex lives. Of the 16 participants, nine were sexually active, all of whom said their sexual activity had been hampered by faecal incontinence. Seven of these nine reported an improvement in their sexual lives after SNS, with greater improvement for younger patients.
The second study investigated perception of success after anal sphincter repair for obstetric trauma231. Patients rated incontinence outcomes before and after the operation. 71% of patients with a successful outcome reported improvement in overall bowel control. These patients were also asked to rate their perceived change in incontinence symptoms. This showed a decrease in time with 85% (median score) of patients perceiving an improvement at 15 months compared to 50% at 77 months. No patient was fully continent. The results suggested that postoperative scores were affected by patients’ perception of success. For instance, patients who had unsuccessful operations tended to rate preoperative incontinence outcomes higher than patients with successful operations did. This demonstrates the difficulty in using subjective assessment to evaluate interventions.
The third study investigated the views of 69 patients who had previously undergone colostomy operation (median 59 months previously). A majority thought that a stoma restricted their life ‘a little’ or ‘not at all’ (83%). Satisfaction with the stoma was 9/10 (median score), although a minority hated it. Five patients described life as being ‘a nightmare’, or ‘hating themselves’. However, 84% of patients claimed they would ‘probably’ or ‘definitely’ have the stoma again. When asked to comment on how much change having a stoma made to quality of life, the median rating (from −5 to 5) was +4.5. However, this patient group was a self-selected sample and may not be representative.
7.7. Recommendations
All people with faecal incontinence considering or being considered for surgery should be referred to a specialist surgeon to discuss:
the surgical and non-surgical options appropriate for their individual circumstances
the potential benefits and limitations of each option, with particular attention to long-term results
realistic expectations of the effectiveness of any surgical procedures under consideration.
Rationale: Although no specific evidence was retrieved for this recommendation the GDG considered that it is important to have a logical plan of action for the management of faecal incontinence and to provide adequate information on the options.
People with a full-length external anal sphincter defect that is 90° or greater (with or without an associated internal anal sphincter defect) and faecal incontinence that restricts quality of life should be considered for sphincter repair. People should be given a realistic expectation of what this operation can achieve and information about possible adverse events, in both the short and long term.
Rationale: Evidence retrieved in section 7.4.3 was considered by the GDG. After consulting with expert advisors and participating in a consensus development exercise the GDG made the above recommendation.
Identification of which symptoms trouble the patient and what can be achieved by repair is essential. Thus continence to flatus can rarely be restored once lost and dietary modification with medication may be more helpful. Urgency is incapacitating but may not be improved by repair. In the main it is incontinence to solid stools that is helped by repair. On the other hand, passive soiling due to loss of internal sphincter function is rarely helped by surgery.
Patients need to understand that the results tend to deteriorate with time so this is an important consideration.
A patient with early onset incontinence after an obstetric or other injury to the external anal sphincter or with a combined IAS defect should be considered for repair. In later onset incontinence, where the defect may have been present for some time, caution should be exercised since the defect may not necessarily be the only cause of incontinence as it might have been expected to cause symptoms earlier if that were the case. It seems reasonable only to repair larger defects as smaller defects would be expected to have less influence on overall continence.
People with internal sphincter defects, pudendal nerve neuropathy, multiple defects, external sphincter atrophy, loose stools or irritable bowel syndrome should be informed that these factors are likely to decrease the effectiveness of anal sphincter repair.
Rationale: No specific evidence was retrieved examining conditions that would lead to anal sphincter repair being less effective. After consulting with expert advisors and participating in a consensus development exercise the GDG recommended that patients should be informed that the effectiveness of anal sphincter repair decreases with the factors described above.
Expert opinion suggests that most surgeons have found that it is impossible to successfully repair the internal anal sphincter successfully. If passive soiling is the main complaint and an IAS defect is present, then patients need to understand that a successful outcome is probably not to be expected.
Attempts have been made to identify tests predictive of the results of sphincter repair. Measurement of pudendal neuropathy has shown poor correlation with outcome of sphincter repair. Nerve injury results in muscular atrophy. MRI may identify atrophy and anal ultrasound also provides some qualitative assessment of external anal sphincter muscle thickness.
Irritable bowel syndrome (IBS) and diarrhoea/loose stools are more difficult to control and the outcome of repair is less predictable in patients with diarrhoea.
People undergoing anal sphincter repair to manage their faecal incontinence should not routinely receive a temporary defunctioning stoma.
Rationale: Evidence retrieved in section 7.3.3 was considered by the GDG. After consulting with expert advisors and participating in a consensus development exercise the GDG recommended that a temporary defunctioning stoma should not be used for routine practice during sphincter repair surgery. Certain clinical situations may make a stoma advisable and this is up to individual surgeons to consider.
People undergoing anal sphincter repair should not receive constipating agents in the postoperative period and should be allowed to eat and drink as soon as they feel able to.
Rationale: After considering the evidence retrieved in section 7.3.3, consulting with expert advisors and participating in a consensus development exercise the GDG recommended that patients undergoing anal sphincter repair should not receive constipating agents in the post-operative period. The randomised trial272 retrieved did not shown any benefit from this policy. Indeed passage of a constipated stool days after the repair may be traumatic to the sphincter repair and may prolong hospital stay.
A trial of temporary sacral nerve stimulation should be considered for people with faecal incontinence in whom sphincter surgery is deemed inappropriate
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. These may be patients with intact anal sphincters, or those with sphincter disruption. In those with a defect contraindications to direct repair may include atrophy, denervation, a small defect, absence of voluntary contraction, fragmentation of the sphincter or a poor-quality muscle.
All individuals should be informed of the potential benefits and limitations of this procedure and should undergo a trial stimulation period of at least 2 weeks to determine if they are likely to benefit. People with faecal incontinence should be offered sacral nerve stimulation on the basis of their response to percutaneous nerve evaluation during specialist assessment, which is predictive of therapy success. People being considered for sacral nerve stimulation should be assessed and managed at a specialist centre with experience of performing this procedure.
Rationale: Evidence retrieved in section 7.4 was considered by the GDG. After consulting with expert advisors and participating in a consensus development exercise the GDG recommended that SNS should be considered for patients with faecal incontinence where sphincter surgery is not appropriate. The simplicity of a trial of SNS makes it an attractive first option (section 7.4.14). A successful trial can be followed by a permanent implant. For those failing an implant, the other options can be considered. Recent data have suggested that SNS is successful in approximately 60% of patients tested218. The great advantage of temporary stimulation is it allows a trial before permanent implantation. This avoids the potential morbidity associated with implantation of a stimulator, and avoids unnecessary expenditure.
There are few long-term studies on SNS and as yet little information on which groups are more likely to do well.
The mode of action of SNS is not clearly understood. The crossover study carried out by Leroi and colleagues218 found that a minority of patients selected the ‘Off’ mode, which appeared to be effective.
If the longer term clinical outcomes (currently not known) turn out to be as positive as the early results, then SNS will be cost-effective in patients with severe life-limiting FI who have not responded to conservative management. Furthermore, it is likely to be cost-saving compared with stoma formation.
Antegrade irrigation via appendicostomy, neo-appendicostomy or continent colonic conduit may be considered in selected people with constipation and colonic motility disorders associated with faecal incontinence.
Rationale: Although no evidence was retrieved for this recommendation, the GDG made the above recommendation after consulting with expert advisors and participating in a consensus development exercise. Evacuatory disorders and colonic motility problems frequently co-exist with faecal incontinence. These are a challenge to the clinician. On the basis that an empty rectum is likely to leave the patient continent, these approaches have great appeal. However, they are not simple and as in any area of surgery case selection is the key. An appendicostomy is the simplest option but if the appendix has been removed then options using an ileal conduit with one end intussuscepted into the ascending colon are available. An alternative is the continent colonic conduit. These are all quite complex procedures and not effective in all patients.
If a trial of sacral nerve stimulation is unsuccessful, an individual can be considered for a neosphincter, for which the two options are a stimulated graciloplasty or an artificial anal sphincter27. People should be informed of the potential benefits and limitations of both procedures. People offered these procedures should be informed that they may experience evacuatory disorders and/or serious infection, either of which may necessitate removal of the device. People being considered for either procedure should be assessed and managed at a specialist centre with experience of performing these procedures. If an artificial anal sphincter is to be used, there are special arrangements that should be followed as indicated in NICE interventional procedures guidance
66.
Rationale: Evidence retrieved in sections 7.1.3, 7.2.3, 7.4.8 and 7.4.10 was considered by the GDG. After consulting with expert advisors and participating in a consensus development exercise the GDG made the above recommendation. Device problems are common and revisional surgery is often required. Patients needs to be highly motivated and prepared to accept the prospects of failure and revisional surgery. The choice between artificial anal sphincter and dynamic graciloplasty will depend on local expertise.
Dynamic graciloplasty is likely to be borderline cost-effective in patients with severe life-limiting FI who have not responded to conservative management. Furthermore, it is likely to be cost-saving compared with stoma formation.
People who have an implanted sacral nerve stimulation device, stimulated graciloplasty or an artificial anal sphincter should be offered training and ongoing support at a specialist centre. These people should be monitored, have regular reviews and be given a point of contact.
Rationale: Evidence retrieved in section 7.1.3, 7.2.3, 7.4.8, 7.4.10 and 7.4.14 was considered by the GDG. After consulting with expert advisors and participating in a consensus development exercise the GDG recommended that following SNS, DGP or artificial anal sphincter patients should receive training, support and regular reviews. Evacuation disorders are very frequently made worse after implantation of an artificial anal sphincter or gracilis neosphincter. Thus it is important to select patients who appear to achieve satisfactory rectal emptying.
A stoma should be considered for people with faecal incontinence that severely restricts lifestyle only once all appropriate non-surgical and surgical options, including those at specialist centres, have been considered. Individuals should be informed of the potential benefits, risks and long-term effects of this procedure. Individuals assessed as possible candidates for a stoma should be referred to a stoma care service.
Rationale: Although no evidence was retrieved for this recommendation, the GDG made the above recommendation after consulting with expert advisors and participating in a consensus development exercise. The GDG felt that it is important to counsel patients that a stoma is not necessarily a simple procedure that will cure all their problems. As with any operation, there may be a price to pay in terms of the outcome. Many develop defunctioned proctitis that in severe cases may necessitate rectal excision. Patients are frequently left with incontinence of mucus and troublesome mucus plugs. A substantial proportion develop stoma related hernias and many require repair.
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