Stapled transanal rectal resection for obstructed defaecation syndrome - interventional procedures consultation document

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Stapled transanal rectal resection for obstructed defaecation syndrome

Obstructed defaecation syndrome is characterised by the urge to pass faeces but an impaired ability to do so. It may be caused by a structural problem in the rectum. Common symptoms include constipation, excessive straining, pain and bleeding after passing faeces. In stapled transanal rectal resection (STARR), two circular staplers or a specific stapling device are used to remove the damaged part of the rectum and join the remaining parts back together.

The National Institute for Health and Clinical Excellence (NICE) is stapled transanal rectal resection for obstructed defaecation syndrome and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about stapled transanal rectal resection for obstructed defaecation syndrome.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 23 March 2010

Target date for publication of guidance: June 2010

 

1       Provisional recommendations

1.1  Current evidence on the safety and efficacy of stapled transanal rectal resection (STARR) for obstructed defaecation syndrome (ODS) is adequate in the context of this condition, which can significantly affect quality of life. The procedure may therefore be used with normal arrangements for clinical governance, consent and audit.

1.2  Stapled transanal rectal resection for ODS should be carried out only in units specialising in the investigation and management of pelvic floor disorders. Patient selection and management should involve a multidisciplinary team including a urogynaecologist or urologist and a colorectal surgeon.

2       The procedure

2.1    Indications and current treatments

2.1.1  Obstructed defaecation syndrome is a complex and multifactorial condition, characterised by an urge to defecate but an impaired ability to expel the faecal bolus. Symptoms include unsuccessful faecal evacuation attempts, excessive straining, pain, bleeding after defaecation and a sense of incomplete faecal evacuation. ODS is often associated with structural defects in the rectum such as rectocele, internal rectal prolapse and perineal descent. Women, particularly multiparous women, are more likely to present with symptoms of ODS than men.

2.1.2  Conservative treatments include diet, biofeedback, laxatives and pelvic floor retraining. In patients refractory to conservative treatment and/or if a structural abnormality is present, surgery may be considered including stapled transanal prolapsectomy and perineal levatorplasty (STAPL).

2.2    Outline of the procedure

2.2.1  Patients having STARR usually receive bowel preparation and prophylactic antibiotics prior to surgery. Under spinal or general anaesthesia, a circular anal dilator is introduced into the anal canal and secured with skin sutures. Resection of the redundant parts of the anterior and posterior rectal walls is done sequentially. Traction sutures are inserted (with an anoscope to aid visualisation) above the anorectal junction to prolapse the redundant rectal wall into the anvil of a stapler which is then fired to produce a full thickness distal resection. The opposite posterior or anterior wall is protected with a spatula. Any bleeding at the circumferential staple line is controlled with interrupted sutures.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP328aoverview.

 

2.3    Efficacy

2.3.1  A randomised controlled trial (RCT) of 50 patients treated by STARR or STAPL reported a good or excellent clinical outcome (1–2 episodes per month or symptom free) in 88% (22/25) and 76% (19/25) of patients respectively at 20-month follow-up. An RCT of 119 patients treated by STARR or biofeedback reported treatment success (defined as a decrease in ODS score of ≥ 50% at 1 year) in 82% (44/54) and 33% (13/39) of patients respectively (p < 0.0001).

2.3.2  A non-randomised comparative study of 73 patients reported a  failure rate of 17% (6/36) for women treated by STARR and 22% (8/37) for women treated by transvaginal repair at mean follow-ups of 8 months and 14 months respectively (p = 0.80).

2.3.3  Register data on 2838 patients reported a mean baseline ODS score (a higher score indicates more severe symptoms) of 17.8 (95% confidence interval [CI] 15.5 to 16.0). This reduced to 5.8 (95% CI 5.3 to 6.4) at 12-month follow-up among 2224 patients treated by STARR (p < 0.001).

2.3.4  The Specialist Advisers listed key efficacy outcomes as reduction in obstructed defaecation symptoms and improvement in quality of life.

2.4    Safety

2.4.1  Septic events (not otherwise described) were reported in 4% (124/2838) of patients in a register. In a case series of 38 patients, one patient developed septic shock and died as a result of necrotising pelvic fasciitis.

2.4.2  The register of 2838 patients reported 1 case of rectal necrosis requiring a diverting stoma (timing of event not stated).

2.4.3  Early stenosis was reported in 1 patient in each treatment group in the RCT of STARR (25 patients) versus STAPL (25 patients) and in 2% (2/90), 2% (2/85) and 1% (1/104) in case series of 90, 85 and 104 patients. A 3% incidence of stenosis was reported after 1 month in the case series of 90 patients.

2.4.4  One case of rectovaginal fistula (timing of event not stated) was reported from the register of 2838 patients. A report of 38 patients referred for complications after STARR described 3 cases of rectovaginal fistula (timing of events not stated).

2.4.5  Postoperative faecal incontinence was reported in 8% (3/36) of patients treated by STARR and 3% (1/37) of patients treated by transvaginal repair (follow-up not stated) in the non-randomised comparative study of 73 patients; and in 22% (23/104) of patients at 1-month follow-up and 9% (9/104) of patients at 12-month follow-up in the case series of 104 patients.

2.4.6  Dyspareunia was reported in less than 1% (3/2838) of patients from the register of 2838 patients.

2.4.7  Defaecatory urgency was reported in 16% (4/25) and 4% (1/25) of patients treated by STARR or STAPL respectively (within 7 days after surgery). In two case series, rates of defaecatory urgency decreased from 27% (28/104) and 18% (16/90) respectively at 1-month follow-up to 6% (6/104) and 1% (1/90) respectively at 12-month follow-up.

2.4.8  Instances of bleeding were reported in all 9 studies with rates of 2% (1/54), 3% (3/104), 3% (2/68), 4% (1/25), 4% (4/90), 5% (143/2838), 7% (2/29), 12% (10/85) and 19% (7/36). In 5 of these studies, at least 1 patient required readmission or reoperation for bleeding.

2.4.9  The Specialist Advisers listed theoretical adverse events as pain, staple line complications, rectal wall perforation and rectal wall haematoma.

2.5   Other comments

2.5.1  The Committee noted that the procedure may sometimes be followed by defaecation urgency and by incontinence. However, it remains unclear whether these sequelae are caused by the procedure or whether they are the results of pre-existing abnormalities.

2.5.2  NICE received 9 completed questionnaires from patients treated by the procedure. Five of the patient commentators reported substantial improvements in quality of life after the procedure.

3     Further information

3.1  This procedure is a review of IPG169 published in 2006.

3.2  For related NICE guidance see www.nice.org.uk.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
February 2010

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This page was last updated: 19 August 2015