Single-incision laparoscopic cholecystectomy - Interventional Procedures Consultation Document
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Single incision laparoscopic cholecystectomy
Gallstones can cause recurrent pain, inflammation of the gallbladder (cholecystitis), jaundice and pancreatitis. Some people with gallstones may need an operation to remove the gallbladder, called a cholecystectomy. It is usually done through ‘keyhole surgery’ using several small cuts. This procedure aims to carry out the operation through a single cut or ‘keyhole’.
The National Institute for Health and Clinical Excellence (NICE) is examining single incision laparoscopic cholecystectomy 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 single incision laparoscopic cholecystectomy .
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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 24 February 2010
Target date for publication of guidance: May 2010
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of single incision laparoscopic cholecystectomy (SILC) is limited to small numbers of patients. Since the main potential advantage to patients of this procedure is cosmetic, there is a particular need for good safety data. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake SILC should take the following actions.
· Inform the clinical governance leads in their Trusts.
· Ensure patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
· Audit and review clinical outcomes of all patients having SILC (see section 3.1).
1.3 SILC is technically challenging and should only be carried out by experienced laparoscopic surgeons who have received specific training in the procedure.
1.4 NICE encourages publication of further evidence on the incidence of complications and comparison of the outcomes of this procedure with standard laparoscopic cholecystectomy, to inform future judgments about the balance of risks and benefits. NICE may review this guidance when further evidence has been published.
2 The procedure
2.1 Indications and current treatments
2.1.1 Gallstones (cholelithiasis) are a common condition. Most people with gallstones are asymptomatic but some may develop recurrent symptoms, typically post-prandial abdominal pain. In some patients, gallstones may lead to acute inflammation of the gallbladder (acute cholecystitis) causing pain, fever, and sometimes severe illness. Displacement of gallbladder stones into the common bile duct may cause painful biliary colic, obstructive jaundice or acute pancreatitis.
2.1.2 The standard treatment for symptomatic gallstones is cholecystectomy. This is usually performed via a laparoscopic approach, using several small incisions in the abdomen.
2.2 Outline of the procedure
2.2.1 Single incision laparoscopic cholecystectomy is carried out using a single umbilical skin incision through which a laparoscope and two instruments are introduced. A special umbilical port may be used to facilitate their placement. Cholecystectomy is performed. Additional ports may be added in the upper abdomen if a cholangiogram is performed or the common bile duct explored.
|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/IP796overview.|
2.3.1 In a randomised controlled trial (RCT) of 90 patients, a non-randomised comparative study of 58 patients, and four case series of 40, 37, 20 and 10 patients, the number of patients requiring trocar insertion via an additional (second) incision during SILC was 29% (13/45), 7% (2/29), 8% (3/40), 14% (5/37), 15% (3/20) and 40% (4/10) respectively. There were no reports of conversion to open surgery.
2.3.2 The case series of 26 patients reported a ‘good clinical outcome’ in all patients at 1-month follow-up, with better cosmetic results than with the traditional laparoscopic approach. Case series of 5 and 20 patients reported that all patients had ‘barely’ or ‘hardly’ visible scars at 6-month and 6-week follow-up respectively. In a case series of 10 patients, 83% (5/6) of patients treated by the procedure were ‘completely satisfied’.
2.3.3 The RCT of 90 patients treated by SILC or standard laparoscopic cholecystectomy reported mean operating times of 94 minutes and 85 minutes respectively (significance not stated). The median length of hospital stay was 3 days for both treatment groups. In a non-randomised comparative study of 58 patients, mean operating time was 74 minutes for SILC and 71 minutes for standard laparoscopic cholecystectomy (significance not stated). The mean length of hospital stay was 1 day for both groups. Across 7 case series, the mean operating time for SILC ranged from 40 to 148 minutes.
2.3.4 The Specialist Advisers listed key efficacy outcomes as quality of life score, recovery time and cosmesis.
2.4.1 Mesenteric injury (managed conservatively) and injury to the right hepatic duct (treated by endoscopic retrograde biliary drainage stent insertion, removed after 4 months) were reported in 1 patient each in the case series of 37 patients.
2.4.2 Gallbladder perforation (management not described) was reported in 30% (11/37) of patients in the case series of 37 patients.
2.4.3 Cystic artery haemorrhage and bilioma (caused by cystic duct leak due to clip slippage; patient suffered mild jaundice and fever) were reported in 1 patient each in the case series of 10 patients. Intra-abdominal free-fluid collection (not otherwise described) was reported in 1 patient at 2-day follow-up in the case series of 12 patients (reported as caused by ‘bleeding from the liver’, it resolved spontaneously).
2.4.4 Bleeding requiring transfusion was reported in 1 patient in the case series of 37 patients.
2.4.5 In the RCT of 90 patients treated by SILC or standard laparoscopic cholecystectomy, the median pain scores (reported on a 10 point visual analogue scale from 0 to 10; higher score indicates worse pain) were 2 (0–5.5) and 3.5 (1–7.5) respectively at 8-hour follow-up, and 2 (0–5.5) and 3.5 (0–6.5) respectively at 12-hour follow-up (p < 0.01 at both 8 and 12 hours). In the non-randomised comparative study of 58 patients, 7% (2/29) of patients treated by SILC and 0% (0/29) of patients treated by standard laparoscopic cholecystectomy required an additional night in hospital because of postoperative pain.
2.4.6 The RCT of 90 patients treated by SILC or standard laparoscopic cholecystectomy reported lower mean analgesic (ketorolac) consumption within the first 24 hours after surgery among patients in the SILC group compared with the control group (88 mg and 113 mg respectively) (p < 0.05).
2.4.7 The Specialist Advisers considered theoretical adverse events to include increased risk of bile duct injury, haemorrhage, gallbladder perforation and incisional hernia.
3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.
Chairman, Interventional Procedures Advisory Committee
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 28 May 2010