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Effectiveness of exenterative surgery for locally advanced or recurrent rectal cancer
Evidence review C5
NICE Guideline, No. 151
National Guideline Alliance (UK).
Effectiveness of exenterative surgery for locally advanced or recurrent rectal cancer
This evidence review supports recommendation 1.3.10.
Review question
What is the effectiveness of exenterative surgery for locally advanced or recurrent rectal cancer?
Introduction
Extensive surgery is often the only method available to achieve local control and potential cure for advanced or recurrent rectal cancer. Pelvic exenteration is a major surgical procedure where all or most organs in the pelvic cavity are removed. However, pelvic exenteration is also associated with high rates of morbidity and changes to quality of life (Ferenschild 2009).
Therefore, the aim of the review is to study the impact that pelvic exenteration has on quality of life, survival, and cancer outcomes among people with locally advanced or locally recurrent rectal cancer. The rate of perioperative complications will also be studied.
Summary of the protocol
Please see Table 1 for a summary of the population, intervention, comparison and outcomes (PICO) characteristics of this review.
Table 1
Summary of the protocol (PICO) table.
For further details see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual 2014. Methods specific to this review question are described in the review protocol in appendix A.
Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).
Clinical evidence
Included studies
One cohort study (N=117) was included in this review (Choy 2017).
The included study is summarised in Table 2.
The study compared pelvic exenteration to non-exenterative treatment, which included chemotherapy, radiotherapy, chemotherapy + radiotherapy or palliative surgery.
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Excluded studies
Studies not included in this review with reasons for their exclusions are provided in appendix K.
Summary of clinical studies included in the evidence review
A summary of the study that was included in this review is presented in Table 2.
Table 2
Summary of included study.
Quality assessment of clinical outcomes included in the evidence review
See the full evidence tables in appendix D and the forest plots in appendix E.
Economic evidence
Included studies
A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.
Excluded studies
A global search of economic evidence was undertaken for all review questions in this guideline. See Supplement 2 for further information.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.
Evidence statements
Clinical evidence statements
Comparison: Pelvic exenteration versus non-exenterative treatments
Critical outcomes
Quality of life
- Very low quality evidence from 1 prospective cohort study (N=117) showed no clinically important difference in quality of life (measured using AQoL scale) at 12 months between those receiving pelvic exenteration compared to those receiving non-exenterative treatments.
- Very low quality evidence from 1 prospective cohort study (N=117) showed no clinically important difference in quality of life (measured using SF-6D scale) at 12 months between those receiving pelvic exenteration compared to those receiving non-exenterative treatments.
Overall survival
No evidence was identified to inform this outcome.
Local recurrence
No evidence was identified to inform this outcome.
Important outcomes
Distant metastases
No evidence was identified to inform this outcome.
Disease-free survival
No evidence was identified to inform this outcome.
Perioperative mortality
- Very low quality evidence from 1 prospective cohort study (N=117) showed no clinically important difference in 30-day mortality between receiving pelvic exenteration compared to non-exenterative treatments.
- Very low quality evidence from 1 prospective cohort study (N=117) showed a clini cally significant decrease in 12-month mortality between receiving pelvic exenteration compared to non-exenterative treatments.
Perioperative complications
- Very low quality evidence from 1 prospective cohort study (N=117) showed a clinically significant increase in perioperative complications between receiving pelvic exenteration compared to non-exenterative treatments.
Economic evidence statements
No economic evidence was identified which was applicable to this review question
The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most
Quality of life was a critical outcome because of the impact that such a complex and invasive procedure as pelvic exenteration can have on patients’ functioning and the potential long term adverse effects. Overall survival and local recurrence were also considered critical outcomes for decision making because local recurrence suggests ineffective treatment of the locally advanced or locally recurrent rectal cancer, potentially requiring further treatment and affecting overall survival. Local recurrence can also cause potentially devastating symptoms.
Distant metastasis and disease-free survival were important outcomes because they suggest ineffective control of the locally advanced or locally recurrent disease. Additionally, perioperative mortality and perioperative complications were also important outcomes, as they are indicative of the short-term side effects of treatments.
The quality of the evidence
Evidence was available from one study that compared pelvic exenteration to non-exenterative treatments, which included radiotherapy, chemotherapy, radiotherapy plus chemotherapy or palliative surgery. Evidence was available for quality of life, perioperative mortality and perioperative complications. There was no evidence for overall survival beyond 12 months, local recurrence, distant metastases or disease-free survival.
The quality of the evidence was assessed using GRADE and was of very low quality.
The quality of evidence was downgraded because of methodological limitations affecting the risk of bias, indirectness of the study population and imprecision around the risk estimate.
Methodological limitations affecting the risk of bias were generally attributable to patients self-selecting into treatment groups and the subjective nature of some of the outcomes, as well as the study not reporting all of the outcomes that were listed in as outcomes of the study.
Indirectness of the study population was attributable to a proportion of the control group receiving palliative surgery (colostomy, ileostomy closure and local excision).
Uncertainty around the risk estimate was generally attributable to low event rates and small sample sizes.
Benefits and harms
The committee agreed that the evidence was limited and of poor quality. However, based on the limited evidence and their clinical expertise, the committee decided to recommend considering referring people with locally advanced recurrent rectal cancer to specialist centres to discuss exenterative surgery. Exenterative surgery is complex and complicated, therefore, a specialist centre is required to perform the sur gery. The option of pelvic exenteration may be suitable for those people with locally advanced or recurrent rectal cancer who might potentially need multi-visceral or be yond-TME surgery, meaning more extensive surgery than the standard TME.
The committee noted that with more people being referred to specialist centres to discuss the option of exenterative surgery, more people will be considered for potentially curative surgery who may have otherwise only have received palliative treatments. However, pelvic exenteration is a complex and invasive surgery that is often accompanied by changes to lifestyle, notably, post-operative complications, the possibility of two stomas and subsequent changes to quality of life. Due to the severity of the side effects of exenteration, it is crucial that patients are aware of these potential complications and issues before proceeding with surgery.
Despite the lack of evidence the committee did not make a research recommendation because a prospective comparative study would not be feasible due to the low number of eligible participants. They also acknowledged that an international collaborative study of outcomes after pelvic exenteration (PelvEx) is already underway.
Cost effectiveness and resource use
A systematic review of the economic literature was conducted but no relevant studies were identified which were applicable to this review question.
The recommendations may increase the number of referrals to specialist centres and therefore may also increase the number of exenteration procedures. The committee highlighted that pelvic exenteration is an expensive operation due to several factors including prolonged surgical and recovery time and length of hospital stay. However, pelvic exenteration can potentially increase survival for patients with locally advanced or recurrent rectal cancer and so may be a cost effective of resources. Given the significant associated morbidities it is likely that only some of this patient group would opt for such a procedure. While there is a potential cost impact associated with the recommendations, given the more expensive interventions only impact upon a small proportion of the patient group, it is not expected to be significant.
Other factors the committee took into account
Data from the PelvEx Collaborative’s international collaboration assessing patient outcomes after pelvic exenteration (PelvEx 2017; PelvEx 2018) were not included in the analysis of this review because the data was not comparative. However, the committee discussed the study’s results due to their value in demonstrating the effect of exenteration on survival outcomes. For 1291 patients with locally advanced primary rectal cancer who had pelvic exenteration, negative resection margins (R0) were achieved in 79.9% of patients, 30-day post-operative mortality was 1.5%, and median overall survival and 3-year overall survival following R0 resections was 43 months and 56.4%, respectively (PelvEx 2017). For 1184 patients with locally recurrent rectal cancer, negative resection margins were achieved in 55.4% of patients, 30-day post-operative mortality was 1.8%, and median overall survival and 3-year overall survival following R0 resections were 36 months and 48.1%, respectively (PelvEx 2018).
The committee recognised that there may barriers to access specialist centres for some people far away from these centres due to the distance and because of difficulty or cost of transport. The option of receiving treatment in a centre far away from home and family members could impact the decision that a patient makes about their care. Barriers to care in specialist centres for those living far away from these centres could be alleviated by ensuring transport is available to those who require assistance and suitable hostel type accommodation for relatives and carers is made available at major referral sites when daily visiting is not realistic because of the distance.
References
Austin 2009
Austin K and Solomon M (2009) Pelvic exenteration with en bloc iliac vessel resection for lateral pelvic wall involvement. Diseases of the Colon and Rectum 52(7): 1223–1233 [PubMed: 19571697]Choy 2017
Choy I, Young J, Badgery-Parker T, et al. (2017) Baseline quality of life predicts pelvic exenteration outcome. Australian and New Zealand Journal of Surgery, 87(11): 935–939 [PubMed: 26687437]Ferenschild 2009
Ferenschild F, Vermaas M, Verhoef C, et al. (2009) Total pelvic exenteration for primary and recurrent malignancies. World Journal of Surgery 33(7): 1502–1508 [PMC free article: PMC2691931] [PubMed: 19421811]Leppink 2017
Leppink J, O’sullivan P and Winston K, (2017) Are differences between groups different at different occasions? Perspectives on Medical Education 6(6): 413–417 [PMC free article: PMC5732103] [PubMed: 29071548]PelvEx 2017
PelvEx Collaborative (2019) Surgical and Survival Outcomes Following Pelvic Exenteration for Locally Advanced Primary Rectal Cancer: Results from an International Collaboration. Annals of Surgery 09(21) [PubMed: 28938268]PelvEx 2018
PelvEx Collaborative (2018) Factors affecting outcomes following pelvic exenteration for locally recurrent rectal cancer. British Journal of Surgery 105(6) 650–657 [PubMed: 29529336]Young 2014
Young J, Badgery-Parker T, Masya L, et al. (2014) Quality of life and other patient-reported outcomes following exenteration for pelvic malignancy. British Journal of Surgery 101(3): 277–287 [PubMed: 24420909]
Appendices
Appendix A. Review protocol
Review protocol for review question: What is the effectiveness of exentera tive surgery for locally advanced or recurrent rectal cancer?
Appendix B. Literature search strategies
Literature search strategies for review question: What is the effectiveness of ex enteration for locally advanced or recurrent rectal cancer?
Databases: Embase/Medline
Last searched on: 15/02/2019
| # | Search |
|---|---|
| 1 | (exp colorectal cancer/ or exp colon tumor/ or exp rectum cancer/ or exp rectum tumor/ or exp rectum carcinoma/) use emez |
| 2 | (exp rectal neoplasms/ or exp colorectal neoplasms/) use ppez |
| 3 | ((colorect* or colo rect* or colon or colonic or rectal or rectum) adj3 (adenocarcinoma* or cancer* or carcinoma* or malignan* or neoplas* or oncolog* or tumo?r*)).tw. |
| 4 | or/1–3 |
| 5 | pelvis exenteration/ use emez |
| 6 | Pelvic exenteration/ use ppez |
| 7 | exenterat*.tw. |
| 8 | Evisceration/ use emez |
| 9 | eviscerat*.tw. |
| 10 | ((Abdominosacral or abdomin* sacral) adj3 resect*).tw. |
| 11 | (multiviscer* adj3 resect*).tw. |
| 12 | ((Sacropelvic or sacral) adj3 resect*).tw. |
| 13 | sacrectom*.tw. |
| 14 | (pelvic adj3 resect*).tw. |
| 15 | radical resect*.tw. |
| 16 | or/5–15 |
| 17 | 4 and 16 |
| 18 | limit 17 to english language |
| 19 | limit 18 to yr=“2000 - current” |
| 20 | remove duplicates from 19 |
| 21 | Letter/ use ppez |
| 22 | letter.pt. or letter/ use emez |
| 23 | note.pt. |
| 24 | editorial.pt. |
| 25 | Editorial/ use ppez |
| 26 | News/ use ppez |
| 27 | exp Historical Article/ use ppez |
| 28 | Anecdotes as Topic/ use ppez |
| 29 | Comment/ use ppez |
| 30 | Case Report/ use ppez |
| 31 | case report/ or case study/ use emez |
| 32 | (letter or comment*).ti. |
| 33 | or/21–32 |
| 34 | randomized controlled trial/ use ppez |
| 35 | randomized controlled trial/ use emez |
| 36 | random*.ti,ab. |
| 37 | or/34–36 |
| 38 | 33 not 37 |
| 39 | animals/ not humans/ use ppez |
| 40 | animal/ not human/ use emez |
| 41 | nonhuman/ use emez |
| 42 | exp Animals, Laboratory/ use ppez |
| 43 | exp Animal Experimentation/ use ppez |
| 44 | exp Animal Experiment/ use emez |
| 45 | exp Experimental Animal/ use emez |
| 46 | exp Models, Animal/ use ppez |
| 47 | animal model/ use emez |
| 48 | exp Rodentia/ use ppez |
| 49 | exp Rodent/ use emez |
| 50 | (rat or rats or mouse or mice).ti. |
| 51 | or/38–50 |
| 52 | 20 not 51 |
Database: Cochrane Library
Last searched on: 15/02/2019
| # | Search |
|---|---|
| 1 | MeSH descriptor: [Rectal Neoplasms] explode all trees |
| 2 | ((rectal or rectum) near (adenocarcinoma* or cancer* or carcinoma* or malignan* or neoplas* or oncolog* or tumo?r*)) |
| 3 | #1 or #2 |
| 4 | MeSH descriptor: [Pelvic Exenteration] explode all trees |
| 5 | exenterat* |
| 6 | eviscerat* |
| 7 | ((Abdominosacral or abdomin* sacral) near resect*) |
| 8 | (multiviscer* near resect*) |
| 9 | ((Sacropelvic or sacral) near resect*) |
| 10 | sacrectom* |
| 11 | (pelvic near resect*) |
| 12 | radical resect* |
| 13 | {or #4-#12} |
| 14 | #3 and #13 Publication Year from 2000 to 2018 |
Appendix C. Clinical evidence study selection
Clinical study selection for review question: What is the effectiveness of exenter ation for locally advanced or recurrent rectal cancer?
Appendix D. Clinical evidence tables
Clinical evidence tables for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
Appendix E. Forest plots
Forest plots for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
Figure 2. Comparison: Pelvic exenteration versus non-exenterative treatment – 30-day mortality
Figure 3. Comparison: Pelvic exenteration versus non-exenterative treatment – 12-month mortality
Appendix F. GRADE profiles
GRADE profiles for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cance
Appendix G. Economic evidence study selection
Economic evidence study selection for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
A global search of economic evidence was undertaken for all review questions in this guide line. See Supplement 2 for further information.
Appendix H. Economic evidence tables
Economic evidence tables for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
No economic evidence was identified which was applicable to this review question.
Appendix I. Economic evidence profiles
Economic evidence profiles for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
No economic evidence was identified which was applicable to this review question.
Appendix J. Economic analysis
Economic evidence analysis for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
No economic analysis was conducted for this review question.
Appendix K. Excluded studies
Excluded clinical studies for review question: What is the effectiveness of exenteration for locally advanced or recurrent rectal cancer?
Appendix L. Research recommendations
Research recommendations for review question: What is the effectiveness of ex enteration for locally advanced or recurrent rectal cancer?
No research recommendations were made for this review question.
Final
Evidence reviews
Developed by the National Guideline Alliance part of the Royal College of Obstetricians and Gynaecologists
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
- Total pelvic exenteration for locally advanced rectal cancer.[J Am Coll Surg. 2000]Total pelvic exenteration for locally advanced rectal cancer.Law WL, Chu KW, Choi HK. J Am Coll Surg. 2000 Jan; 190(1):78-83.
- Total pelvic exenteration for primary and recurrent malignancies.[World J Surg. 2009]Total pelvic exenteration for primary and recurrent malignancies.Ferenschild FT, Vermaas M, Verhoef C, Ansink AC, Kirkels WJ, Eggermont AM, de Wilt JH. World J Surg. 2009 Jul; 33(7):1502-8.
- Outcomes of pelvic exenteration for locally advanced primary rectal cancer: Overall survival and quality of life.[Eur J Surg Oncol. 2016]Outcomes of pelvic exenteration for locally advanced primary rectal cancer: Overall survival and quality of life.Quyn AJ, Austin KK, Young JM, Badgery-Parker T, Masya LM, Roberts R, Solomon MJ. Eur J Surg Oncol. 2016 Jun; 42(6):823-8. Epub 2016 Feb 24.
- Review Complications of radical cystectomy.[Minerva Urol Nefrol. 2007]Review Complications of radical cystectomy.Buscarini M, Pasin E, Stein JP. Minerva Urol Nefrol. 2007 Mar; 59(1):67-87.
- Review A systematic review examining quality of life following pelvic exenteration for locally advanced and recurrent rectal cancer.[Colorectal Dis. 2017]Review A systematic review examining quality of life following pelvic exenteration for locally advanced and recurrent rectal cancer.Rausa E, Kelly ME, Bonavina L, O'Connell PR, Winter DC. Colorectal Dis. 2017 May; 19(5):430-436.
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