Stapled transanal rectal resection procedure for obstructed defaecation syndrome (interventional procedure consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Stapled transanal rectal resection for obstructed defaecation syndrome

The National Institute for Health and Clinical Excellence is examining stapled transanal rectal resection for obstructed defaecation syndrome and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, 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 preliminary recommendations
the identification of factual inaccuracies
additional relevant evidence.

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

The process that the Institute 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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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

Closing date for comments: 31 January 2006
Target date for publication of guidance: April 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

1	Provisional recommendations

1.1	Current evidence on the safety and efficacy of stapled transanal rectal resection for obstructed defaecation syndrome does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

1.2	Clinicians wishing to undertake stapled transanal rectal resection for obstructed defaecation syndrome should take the following actions. Inform the clinical governance leads in their Trusts. Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). Audit and review clinical outcomes of all patients having stapled transanal rectal resection for obstructed defaecation syndrome.
1.3	The studies are based on heterogenous groups of patients. Patient selection is important in clinical practice and should be clearly defined in future studies.
1.4	Publication of safety and efficacy outcomes will be useful, and the Institute may review the procedure upon publication of further evidence. A registry is in development by the Association of Coloproctology for Great Britain and Ireland, and clinicians are encouraged to enter patients into this registry (www.acpgbi.org.uk).

2	The procedure

*2.1*	*Indications*

2.1.1	Stapled transanal rectal resection (STARR) is indicated for obstructed defaecation syndrome (ODS), a complex and multifactorial condition. ODS is more common in women, particularly multiparous women, than in men.
2.1.2	ODS is characterised by the urge to defaecate 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. Rectocele (herniation of the rectum into the vagina), internal rectal mucosal prolapse and rectal intussusception may also be associated with ODS. Genital prolapse, enterocele and non-relaxing puborectalis may also coexist.
2.1.3	Conservative treatment such as diet, biofeedback or pelvic floor retraining improves symptoms in the majority of patients with ODS. Surgery may be considered in patients for whom conservative treatments have failed and where there is an underlying structural abnormality such as rectocele.
2.1.4	Various surgical procedures can be used to correct the underlying condition. These use abdominal, vaginal or laparoscopic approaches. New procedures including single stapled transanal prolapsectomy and perineal levatorplasty (STAPL) and STARR have been proposed to correct structural abnormality associated with ODS.


*2.2*	*Outline of the procedure*

2.2.1	The STARR procedure uses two circular staplers to produce a circumferential transanal full-thickness resection of the lower rectum. The combination of the two stapled resections aims to correct the structural abnormalities associated with obstructed defaecation syndrome (ODS), namely rectal intussusception, rectocele and mucosal prolapse.
2.2.2	A circular anal dilator is introduced into the anal canal and secured with skin sutures. Up to four sutures are placed in the anterior rectal wall at intervals above the anorectal junction in a semicircumferential manner. A retractor is then positioned to protect the posterior rectal wall. The first circular stapler is introduced into the rectum and the open head positioned above the level of the most proximal suture. The stapler is closed and fired to perform the anterior rectal resection.
2.2.3	The procedure is repeated for the posterior rectal resection. Two or more semicircumferential sutures are placed posteriorly above the anorectal junction. The anterior rectum is protected with a retractor. The second circular stapler is introduced into the rectum with the open head positioned above the level of the most proximal suture. The stapler is closed and fired to perform the posterior rectal resection.


*2.3*	*Efficacy*

2.3.1	In five studies reporting on short-term efficacy, patients reported a reduction in symptoms of ODS following the procedure (follow-up range 2.3-20 months). In a study of 50 women with intussusception and rectocele, 25 who had the STARR procedure experienced an improvement in preoperative constipation symptoms at a 20-month follow-up. Defaecography also demonstrated correction of rectocele and intussusception in all 25 patients. Similar results were found in a study of 54 patients, which reported a significant reduction of the rectocele and intussusception in all patients.

2.3.2	Satisfaction or quality of life following the procedure was assessed in four studies. They all reported either an improvement, or excellent or good outcomes in the majority of patients at final follow-up. In one of these studies, excellent or good outcomes (1-2 episodes per month or symptom free) were reported in 80% of patients (81/90) at 12 months; 6% (5/90) patients reported fairly good outcomes (more than two episodes per month); and 4% (4/90) of patients had unchanged symptoms.For more details, refer to the sources of evidence (see Appendix).
2.3.3	The Specialist Advisors noted that there were limited data on this procedure, and expressed concern about whether the improvements reported in the literature will be sustained in the longer term.


*2.4*	*Safety*

2.4.1	In one study of 90 patients, early complications included five cases of urinary retention (6%), four cases of bleeding requiring readmission (4%) and one case of pneumonia (1%). Complications at 1 month included 16 cases of faecal urgency (18%), eight cases of incontinence to flatus (9%), and two cases of rectal stenosis (2%). At 12 months there was one case of both faecal urgency and incontinence to flatus (1%), and three cases of rectal stenosis (3%).

2.4.2	In another study that specifically reported on 14 patients experiencing complications following the STARR procedure, severe rectal bleeding was reported in two patients, and there was one case of pelvic sepsis. Persistent anal pain was reported in seven patients, three patients had faecal incontinence and symptoms of ODS recurred in seven patients. However, patients in this study included those with non-relaxing puborectalis muscle symptoms, who were excluded from other studies. For more details, refer to the sources of evidence (see Appendix).
2.4.3	The Specialist Advisors noted that there was a risk of rectovaginal fistula following the procedure. They also noted that other complications could include bowel perforation, peritonitis and pelvic sepsis.

3	Further information

3.1	The Institute has issued Interventional Procedures guidance on circular stapled haemorrhoidectomy (www.nice.org.uk/IPG034) and is developing technology appraisal guidance on stapled haemorrhoidectomy (www.nice.org.uk/page.aspx?o=260179).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
January 2006

Appendix:

Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of stapled transanal rectal resection procedure for obstructed defaecation syndrome, August 2005

Available from: www.nice.org.uk/ip328overview

This page was last updated: 22 June 2010