Interventional procedure consultation document

Combined endoscopic and laparoscopic removal of colonic polyps

Colonic polyps are small growths on the inside lining of the large bowel. If left untreated, there is a small risk that polyps may develop into bowel cancer after several years. Combined endoscopic and laparoscopic removal of colonic polyps is done by using both keyhole surgery and a long flexible tube with a tiny camera on the end of it, which is inserted into the bowel through the anus.

The National Institute for Health and Care Excellence (NICE) is examining combined endoscopic and laparoscopic removal of colonic polyps and will publish guidance on its safety and efficacy to the NHS. 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 combined endoscopic and laparoscopic removal of colonic polyps.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, 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 interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that 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: 20 June 2014

Target date for publication of guidance: 24 September 2014

 

 

 

1                      Provisional recommendations

1.1                  Current evidence on the safety and efficacy of combined endoscopic and laparoscopic removal of colonic polyps is adequate. Therefore this procedure may be used with normal arrangements for clinical governance, consent and audit.

1.2                  This procedure should be done only by teams experienced in laparoscopic colonic surgery and complex interventional endoscopy.

 

 

 

 

 

2                      Indications and current treatments

2.1                  Colonic polyps are mucosal lesions that project into the lumen of the large bowel. Most colonic polyps cause no symptoms, but they may cause rectal bleeding, mucus in stools, abdominal pain and rarely diarrhoea or constipation. If left untreated, there is a small risk (approximately 1 in 10) that polyps may develop into bowel cancer after several years.

2.2                  Colonic polyps are usually removed by endoscopic snaring. Polyps that cannot be removed endoscopically are typically large, broad-based, or situated in anatomically inaccessible areas (such as behind mucosal folds) where attempted endoscopic removal could result in bowel perforation. Polyps that are unsuitable for endoscopic removal need open or laparoscopic bowel resection.

 

 

 

 

 

3                      The procedure

3.1                  Combined endoscopic and laparoscopic removal of colonic polyps is used to excise polyps that are unsuitable or high-risk for endoscopic removal, without the need for open surgery or segmental laparoscopic resection. The procedure aims to provide enhanced visualisation and enable the colon to be manoeuvred and controlled during resection of the polyp.

3.2                  The procedure is done with the patient under general anaesthesia. The position of the polyp is noted by making intraluminal and extraluminal marks around the polyp using endoscopic coagulation and laparoscopic diathermy respectively. Alternatively, the location of the polyp can be marked using endoscopic tattooing. Sutures are placed laparoscopically (extraluminally) at the marked sites around the polyp. The sutures are then drawn together to invert a fold, containing the polyp, into the colonic lumen. The inversion site is then laparascopically oversewn and the protruding tissue, including the polyp, is removed endoscopically. Alternatively, a wedge excision of the marked polyp is done laparoscopically and the polyp retrieved and removed from one of the laparoscopic port sites. It is then sent for histopathological examination.

 

 

 

 

 

4                      Efficacy

This section describes efficacy 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 interventional procedure overview[RS1] .

4.1                  In a non-randomised comparative study of 123 patients treated by laparoscopic-assisted endoscopic polypectomy (n=25), endoscopic mucosal resection (n=30) or laparoscopic colectomy (n=68) successful removal of polyps was reported in 76%, 77% and 100% of patients respectively.

4.2                  In a case series of 30 patients treated by laparoscopic-assisted endoscopic polypectomy successful removal of polyps was reported in 73% (22/30) of patients. In these patients, all resection margins were clear.

4.3                  In a case series of 23 patients treated either by laparoscopic-assisted endoscopic polypectomy or endoscopy-assisted laparoscopic wedge resection successful removal of polyps was reported in 87% (20/23) of patients.

4.4                  In a case series of 146 patients treated by various combined endoscopic and laparoscopic approaches (including laparoscopic-assisted endoscopic polypectomy [n=8], endoscopy-assisted wedge resection [n=72], endoscopy-assisted transluminal resection [n=40] and endoscopy-assisted segmental resection [n=26]) 1 recurrence of a tubulovillous adenoma was reported at mean follow-up of 2.9 years.

4.5                  In a case series of 176 patients treated by laparoscopic-monitored endoscopic polypectomy no recurrence of resected polyps was observed at median follow-up of 65 months.

4.6                  The specialist advisers listed key efficacy outcomes as complete polyp excision allowing for complete pathological assessment, recurrence rates, reduced morbidity compared against standard laparoscopic resection or traditional surgery, avoidance of major laparoscopic resection and maintenance of bowel function.

 

 

 

 

 

5                      Safety

This section describes 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 interventional procedure overview[RS2] .

5.1                  Conversion to open surgery was needed in 5% (7/146) of patients in a case series of 146 patients treated by various combined endoscopic and laparoscopic approaches (including laparoscopic-assisted endoscopic polypectomy [n=8], endoscopy-assisted wedge resection [n=72], endoscopy-assisted transluminal resection [n=40] and endoscopy-assisted segmental resection [n=26]). The reasons for conversion to open surgery were 3 incidents of suspected malignant tumours, 1 bowel perforation, 2 difficult closures of the resection site and 1 incomplete resection of a polyp.

5.2                  Conversion to a ‘formal resection’ was needed in 2% (4/176) of patients in a case series of 176 patients treated by laparoscopic-monitored endoscopic polypectomy, because of failure of the combined approach: the authors did not state whether formal resection was performed laparoscopically or by open surgery.

5.3                  Wound infections were observed in 10% (14/146) of patients in the case series of 146 patients treated by various combined endoscopic and laparoscopic approaches. In the same study, intra-abdominal abscesses were reported in 2.7% (4/146) of patients: CT-guided drainage of abscesses was needed in 3 patients and 1 patient needed reoperation.

5.4                  Postoperative bleeding, which resolved with conservative treatment, was reported in 3% (1/30) of patients in a case series of 30 patients treated by laparoscopic-assisted endoscopic polypectomy: details of treatment were not provided. In the same study, urinary retention was observed in 7% (2/30) of patients.

5.5                  Atelectasis was reported in 5% (9/176) of patients in a case series of 176 patients treated by laparoscopic-monitored endoscopic polypectomy (time of occurrence not reported). In the same study, seroma was observed in 2% (3/176) of patients and ileus was observed in 2% (4/176) of patients.

5.6                  Specialist advisers stated that inflammatory responses to tattoo ink in adjacent tissues, difficulty with laparoscopy because of gross colonic distension from colonoscopy and post-polypectomy bleeding were anecdotal adverse events.

5.7                  Specialist advisers listed incomplete resection, bleeding that may be difficult to control intraluminally, bowel perforation, anastomotic leak, faecal contamination, infection, missed malignancy, tumour spillage and loss of colonic circumference rendering simple closure difficult or impossible as theoretical adverse events.

 

 

 

 

 

6                      Committee comments

6.1                  The Committee noted that the literature included a range of procedures involving various combinations of endoscopic and laparoscopic techniques for removing colonic polyps. It was advised that these represented a sequence of possible interventions for colonic polyps.

 

 

 

 

 

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
May, 2014

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 It is the responsibility of consultees to accurately cite academic work in order that they can be validated.