NIHR DC Discover

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

Published on 17 July 2018

doi: 10.3310/signal-000620

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.

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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; updated 2015.

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

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; updated 2015.

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

Single-incision laparoscopic cholecystectomy is responsible for increased adverse events: results of a meta-analysis of randomized controlled trials

Published on 11 March 2018

Arezzo, A.,Passera, R.,Forcignano, E.,Rapetti, L.,Cirocchi, R.,Morino, M.

Surg Endosc , 2018

BACKGROUND: Over the last decade, single-incision laparoscopic cholecystectomy (SLC) has gained popularity, although it is not evident if benefits of this procedure overcome the potential increased risk. Aim of the study is to compare the outcome of SLC with conventional multi-incision laparoscopic cholecystectomy (MLC) in a meta-analysis of randomized controlled trials only. METHODS: A systematic Medline, Embase, and Cochrane Central Register of Controlled Trials literature search of articles on SLC and MLC for any indication was performed in June 2017. The main outcomes measured were overall adverse events, pain score (VAS), cosmetic results, quality of life, and incisional hernias. Linear regression was used to model the effect of each procedure on the different outcomes. RESULTS: Forty-six trials were included and data from 5141 participants were analysed; 2444 underwent SLC and 2697 MLC, respectively. Mortality reported was nil in both treatment groups. Overall adverse events were higher in the SLC group (RR 1.41; p < 0.001) compared to MLC group, as well severe adverse events (RR 2.06; p < 0.001) and even mild adverse events (RR 1.23; p = 0.041). This was confirmed also when only trials including 4-port techniques (RR 1.37, p = 0.004) or 3-port techniques were considered (RR 1.89, p = 0.020). The pain score showed a standardized mean difference (SMD) of - 0.36 (p < 0.001) in favour of SLC. Cosmetic outcome by time point scored a SMD of 1.49 (p < 0.001) in favour of SLC. Incisional hernias occurred more frequently (RR 2.97, p = 0.005) in the SLC group. CONCLUSIONS: Despite SLC offers a better cosmetic outcome and reduction of pain, the consistent higher rate of adverse events, both severe and mild, together with the higher rate of incisional hernias, should suggest to reconsider the application of single incision techniques when performing cholecystectomy with the existing technology.

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