Evidence
Alert

Gallbladder surgery through a single-incision is more risky than a multiple incision technique

Single-incision keyhole gallbladder removal surgery carries increased risk of adverse events, such as puncturing the gallbladder, compared with the more standard multiple-incision procedures. However, in experienced hands, there may be benefits such as reduced pain and less scarring after the operation.

Current guidance recognises that using a single incision for laparoscopic cholecystectomy is more complex than using multiple incisions.

The risks and benefits of all options available for patients should be discussed while obtaining informed consent for the operation. The patient may have strong preferences that inform the most appropriate option.

 

Why was this study needed?

About 10 to 15% of adults are thought to have gallstones, but not everyone has symptoms. The gallbladder may be removed if gallstones are painful or cause complications.

Most operations to remove the gallbladder are carried out by keyhole surgery. Access via multiple incisions is standard practice, although single incision access is an option. Adverse events include complications such as puncturing the gallbladder, excessive blood loss, wound infection and hernia at the incision site.

A 2014 Cochrane review looked at four-incision keyhole surgery to remove the gallbladder compared with fewer than four incisions. This found no difference in adverse events between groups, and the proportion of people converting to conventional open surgery was similar.

Single-incision gallbladder removal is technically challenging, but its use may be increasing in the UK. This review looked at the pros and cons of the single-incision approach.

 

What did this study do?

The authors found 46 recent randomised controlled trials in 5,141 people having planned gallbladder removal by keyhole surgery. The review focused on studies reporting adverse events after surgery using one incision versus multiple incisions.

In 37 studies, four incisions were used in the multiple incision group and three incisions were used in the other nine studies. Emergency surgery was not covered by this review, but seven of the studies included some acute cases.

Study quality was assessed with the Cochrane risk of bias tool and most were assessed at low risk of bias, outcome assessors were blinded in 21 trials and this was unclear in 23.

 

What did it find?

  • Adverse events occurred in 11.3% of people having single-incision surgery (245/2,162) and 8.7% of those having multiple incision surgery (211/2,416), relative risk (RR) 1.41, 95% confidence interval (CI) 1.19 to 1.68 (40 studies, 4,578 participants).
  • Severe adverse events (such as injury to the gallbladder and bile leakage) were uncommon overall. They occurred slightly more frequently, 2.7%, in people having single-incision surgery (58/2,132) compared with 1.1% of those having multiple incision surgery (26/2,386), RR 2.06, 95% CI 1.35 to 3.13 (39 studies, 4,518 participants). The greatest increases in risk were for hernia at the incision site and the risk of further operation.
  • People having single-incision surgery had less pain (standardised mean difference [SMD] −0.36, 95% CI −0.53 to −0.18, 40 studies) and better cosmetic results (SMD 1.49, 95% CI 1.12 to 1.85, 22 studies) compared with those who had multiple incision surgery.
  • Single-incision surgery was associated with slightly longer operating times (mean 17 minutes longer, 95% CI 12 to 19, 39 studies).
  • Length of time in hospital and recovery times were similar for people who had either type of operation.

 

What does current guidance say on this issue?

NICE’s 2014 interventional procedures guidance on single-incision surgery for gallbladder removal recommends this procedure is used with normal arrangement for clinical governance, consent and audit. However, the guidance notes that it ‘is technically challenging and should only be carried out by experienced laparoscopic surgeons who have had specific training in the procedure’.

The evidence used to make these recommendations showed no differences in adverse events between single-incision and multiple-incision surgery.

 

What are the implications?

Avoiding harm is important for people having elective surgery because they are usually otherwise well. Some people may prefer single-incision surgery because it causes less scarring and pain afterwards.

The findings suggest that the benefits of single-incision gallbladder removal need balancing against the increased risk of overall and severe adverse events. This should be discussed with the patient as part of informed consent.

The experience of surgeons involved in the studies was not reported, so it is unknown whether greater experience lowers adverse event risk. Therefore, the effect of this study on current recommendations is unclear.

 

Citation and Funding

Arezzo A, Passera R, Forcignanò E, et al. Single-incision laparoscopic cholecystectomy is responsible for increased adverse events: results of a meta-analysis of randomized controlled trials. Surg Endoscop. 2018; March 9. DOI: 10.1007/s00464-018-6143-y.

No funding information was provided for this study.

 

Bibliography

Gurusamy KS, Vaughan J, Rossi M et al. Fewer-than-four ports versus four ports for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(2):CD007109.

NHS Choices. Gallstones. London: Department of Health and Social Care; updated 2018.

NICE. Single-incision laparoscopic cholecystectomy. IPG508. London: National Institute for Health and Care Excellence 2014.

Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre

 

Commentaries

Expert commentary

Single port laparoscopic cholecystectomy uses small instruments and there have been concerns regarding the safety with reduced visibility.

In this high-quality meta-analysis, the trials did suggest some benefit to the single port technique with a significant reduction in pain and improved cosmetic outcome. However, a major concern was the increased incidence of adverse events including a doubling of serious adverse events. Incisional hernias were also significantly increased. The single incision surgery took longer possibly reflecting a technically more complex procedure.

This study has important implications for patients and healthcare providers suggesting single port surgery should be stopped until single port technology has been improved.

Brian R Davidson, Consultant HPB & Liver Transplant Surgeon, Royal Free London & Wellington Hospitals; Professor of Surgery, University College London