Surgeons undertaking continence surgery should be aware of and follow best practice in the management of UI, as laid out in this guideline. Surgeons should conform to standards of good medical practice (General Medical Council) and good surgical practice (Royal College of Surgeons). They should also conform to the standards of good practice as laid out by the British Association of Urological Surgeons Section of Female and Reconstructive Urology (BAUS-SFRU) and the British Society of Urogynaecology (BSUG), namely:
Measuring competence
For established surgeons, the best way to measure continuing competence is through comparative audit. All surgeons should have access to information about their personal results for continence surgery. This should include data on perioperative complications and long-term outcomes. They should also be able to compare those outcomes with the experience of others through national audit.
Examples of this include the databases set up by BSUG and BAUS-SFRU. Both systems offer the facility for surgeons to record every operation they do for incontinence, and are freely available for members of those organisations, although neither is well utilised at present.
Volume–outcome research
The necessary surgical volume of any operation required to maintain competence is inadequately defined. The volume–outcome relationship has been considered in many clinical areas, such as cardiology, gastroenterology, orthopaedics, ophthalmology and breast cancer surgery, but little evaluation has been undertaken in relation to continence surgery. In systematic reviews of this research, many methodological concerns have been raised over what is considered to be a heterogeneous body of research, consisting of observational studies. Most studies retrospectively analyse routinely collected data and are not designed to analyse the complex volume–outcome relationship, which leads to many problems when interpreting the data, namely:921–923
inadequate consideration of confounders such as the effects of differences in case-mix and appropriateness of case selection on outcomes
volume can relate to hospital or surgeon
narrow outcomes are used in most studies, usually adverse (e.g. inpatient or 30 day mortality)
thresholds for, or definitions of, high and low volume across and within procedures differ
causality – it is unclear whether high volume–improved outcome relationships result from greater experience or whether the highest referral rate tends to be to those surgeons or centres who have the best results.
Hospital volume and surgeon volume may both be important, and the relative importance may vary from one procedure to another. For some procedures, such as trauma-related reconstruction, it may be the total amount of relevant surgery that is most important rather than the specific number of particular procedures. Complexity of procedures and whether their use is commonplace also influences whether a difference in outcomes can be seen for a given volume.
Although the evidence tends to suggest that higher volume is associated with better outcomes, the consistency and size of the effect varies for different procedures. A systematic review of 135 studies found a significant association between higher volume (hospital or surgeon) and better outcomes in about 70% of studies; none of the studies found a significant association between higher volume of any type of surgery and poorer outcome.922 In these studies, the definition of low or high volume varied according to the procedure, with median low volumes of up to 100–200 for coronary angioplasty or coronary artery bypass graft surgery; and median low volume values ranging from 1 to 73 for other procedures described (mainly in the region of 10–30).922
Secondary surgery is unusual and can be technically challenging, and a centralisation argument probably applies. The centralisation argument holds that ‘practice makes perfect’ so concentration of cases into one centre that can carry out larger numbers of procedures will result in higher standards, not just in surgical technique, but also postoperative care.
Evidence for the effects of volume or hospital status on outcome of continence surgery
A few studies have reported the outcomes of continence surgery according to the volume of surgery undertaken. With the methodological issues relating to such studies in mind, the findings are described below.
A UK cohort study attempted to identify risk factors predictive of successful outcome 1 year after surgery for stress UI (colposuspension, anterior colporrhaphy or needle suspension). The outcomes considered were complications, symptom severity index, symptom impact index and activities of daily living. The number of cases performed by surgeons per year (20–42 versus 1–19) was not found to be associated with risk of a better or worse outcome (n = 232).125,126 [EL = 2+]
Some information on volume–outcomes is available for retropubic ‘bottom-up’ tapes. One case series considered the cure rates for each of the ten surgeons who undertook the retropubic ‘bottom-up’ tape procedure, which ranged from 72% to 92% and were not significantly associated with the number of procedures performed (11–250 per surgeon).812 From the Finnish national data on retropubic ‘bottom-up’ tapes, it was estimated that the incidence of complications was 40% in hospitals where 15 or fewer operations had been undertaken, and about 14% in centres performing more than 15 operations.813 [EL = 3]
Subgroup analysis of some aspects of the UK retropubic ‘bottom-up’ tape /colposuspension RCT659,660 was undertaken, including volume–outcome and recruitment numbers, although the study was not powered to do so.924 It is difficult to put the numbers into context because those cases represent only a proportion of the continence surgery undertaken in those centres. Objective cure rates were higher for centres recruiting most patients; the categories analysed being more than 30 patients, 21–30, or fewer than 20. While it must be conceded that the effect of drop-outs on an intention-to-treat analysis is greater on units recruiting small numbers of patients, it may nevertheless be the case that there is a minimum workload consistent with optimal surgical outcome.
Other studies reflected on the learning curve with the retropubic ‘bottom-up’ tape procedure. Three studies observed that the complication rate,744,772,804 or specifically bladder injury,925 was relatively higher during the surgeon's learning curve, the threshold/definition for which differed across the studies, from the first 5, 10–20, 50 or 100 procedures.
A survey of consultants performing continence surgery in the UK in 2001 was carried out in order to establish the type and volume of surgery undertaken, the nature of postoperative complications, investigations, and follow-up (n = 578; 54% response rate). The profile of respondents was general gynaecologists (40%), gynaecologists with a special interest in urogynaecology (31%), urologists (25%), subspecialist urogynaecologists (3%), with 2% not classified. Half the respondents stated that fewer than 50 procedures per year were adequate for good surgical results, whereas the other half considered that more than 50 procedures a year were necessary. The majority specialty view was 10–20 procedures per year (61% general gynaecologists and 59% urologists), or 20–50 per procedures per year (68% urogynaecology subspecialists and 61% gynaecologists with a special interest).926 [EL = 3]
The results for the retropubic ‘bottom-up’ tape (7336 procedures) were also reported separately by the same authors, the survey participants being identified by the manufacturers of the device. Overall, 44% performed between one and ten retropubic ‘bottom-up’ tape operations in the year evaluated (2001), and 28% performed over 25 during that year. Performing 10–20 cases of retropubic ‘bottom-up’ tape under supervision was considered by 46% of surgeons in this survey to constitute adequate training, and 43% suggested that 20–50 cases of retropubic ‘bottom-up’ tape are required to gain competence.817 [EL = 3]
Hospital status
There is some conflicting evidence that outcomes relate in part to the training status of the institution in which they are performed. In the USA, teaching centres have been shown to have higher 30-day morbidity (predominantly wound complications) across a range of specialties (general surgery, orthopaedics, urology, and vascular surgery) than non-teaching centres. Mortality was not significantly different between centres for any of the seven specialties evaluated.927 [EL = 2+]
Two studies considered outcome of continence surgery by hospital status (teaching versus nonteaching); exactly what is meant by ‘teaching’ hospitals is not clear. The risk of having complications from continence surgery was not significantly associated with hospital status in a UK cohort study (on multivariate analysis).125,126 [EL = 2+] A case series of retropubic ‘bottom-up’ tape reported that the risk of postoperative complications with a retropubic ‘bottom-up’ tape was higher when undertaken in teaching hospitals than in non-teaching hospitals (24% versus 16%; OR 0.55, 95% CI 0.35 to 0.85) (n = 809).804 [EL = 3] While the studies report these observations, they do not explain the possible causes of the results seen. This may relate to overall case load, case mix (i.e. number of complex or secondary cases) or the impact of training on outcomes.
Evidence statements for competence of surgeons
There are limited data regarding the number of procedures required to learn any particular operation used in the management of urinary incontinence. There is similarly little evidence on annual workload required to maintain skills, optimise outcome and minimise morbidity. [EL = 4] From a survey of consultants performing continence surgery in the UK, the majority specialty view was that either 10–20 or 20–50 procedures per year are adequate for good surgical results. [EL = 3]
From evidence to recommendations
The GDG drew on the requirements for training schemes in gynaecology and urology in the UK to develop recommendations for training standards. The BAUS-SFRU and BSUG are currently developing training schemes and structured assessment methods specific for those undertaking continence surgery.
Cystourethroscopy is considered an integral part of several procedures used in the treatment of UI. Training in this technique is therefore deemed crucial to surgical competence in this area.
In relation to maintaining competence, the GDG agreed by consensus that a workload of 20 cases per procedure per annum was an appropriate volume, which was also supported by the survey of UK consultants. A volume of cases per procedure was recommended because a workload in one procedure does not necessarily maintain skills for other procedures. The minimum volume recommended was also agreed by GDG consensus.
Audit is an integral part of clinical governance. Regular audit of outcomes of continence surgery is considered essential to maintaining standards of practice.
Recommendations
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| Number | Recommendation |
|---|
| 108 | Surgery for UI should be undertaken only by surgeons who have received appropriate training in the management of UI and associated disorders or who work within an MDT with this training, and who regularly carry out surgery for UI in women. [2006] |
| 109 | Training should be sufficient to develop the knowledge and generic skills documented below. Knowledge should include the:
specific indications for surgery required preparation for surgery including preoperative investigations outcomes and complications of proposed procedure anatomy relevant to procedure steps involved in procedure alternative management options likely postoperative progress.
Generic skills should include
the ability to explain procedures and possible outcomes to patients and family and to obtain informed consent the necessary hand–eye dexterity to complete the procedure safely and efficiently, with appropriate use of assistance the ability to communicate with and manage the operative team effectively the ability to prioritise interventions the ability to recognise when to ask for advice from others a commitment to MDT working. [2006]
|
| 110 | Training should include competence in cystourethroscopy. [2006] |
| 111 | Operative competence of surgeons undertaking surgical procedures to treat UI or OAB in women should be formally assessed by trainers through a structured process. [2006] |
| 112 | Surgeons who are already carrying out procedures for UI should be able to demonstrate that their training, experience and current practice equates to the standards laid out for newly trained surgeons. [2006] |
| 113 | Only surgeons who carry out a sufficient case load to maintain their skills should undertake surgery for UI or OAB in women. An annual workload of at least 20 cases of each primary procedure for stress UI is recommended. Surgeons undertaking fewer than 5 cases of any procedure annually should do so only with the support of their clinical governance committee; otherwise referral pathways should be in place within clinical networks. [2006] |
| 114 | There should be a nominated clinical lead within each surgical unit with responsibility for continence and prolapse surgery. The clinical lead should work within the context of an integrated continence service. [2006] |
| 115 | A national audit of continence surgery should be undertaken. [2006] |
| 116 | Surgeons undertaking continence surgery should maintain careful audit data and submit their outcomes to national registries such as those held by the British Society of Urogynaecology (BSUG) and British Association of Urological Surgeons Section of Female and Reconstructive Urology (BAUS-SFRU). [2006] |
