5 Safety

Guidance

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. Much of the evidence considered by the Committee was presented in meta‑analyses from 2 systematic reviews, which reported relative risks in the form of pooled mean differences for continuous outcome variables, and odds ratios for dichotomous variables. Pooled measures of absolute risk were not reported. For more detailed information on the evidence, see the interventional procedure overview.

5.1 In a systematic review of 25 randomised controlled trials that included 1841 patients treated by single‑incision laparoscopic cholecystectomy (SILC) or conventional multiport laparoscopic cholecystectomy (CMLC), meta‑analysis of the incidence of bile duct injuries revealed no significant difference between groups (odds ratio of 1.00; 95% confidence interval [CI] 0.165 to 6.066, p=1.0).

5.2 Gallbladder perforation was reported in 12% (9/75) of patients in the SILC group and 8% (6/75) of patients in the CMLC group in a randomised controlled trial of 150 patients (no p values reported).

5.3 In a systematic review of 40 studies that included 3711 patients treated by SILC or CMLC, meta‑analysis of the incidence of wound haematomas revealed no significant difference between groups (odds ratio of 2.07; 95% CI 0.90 to 4.74, p=0.09).

5.4 In the systematic review of 40 studies that included 3711 patients treated by SILC or CMLC, meta‑analysis of the incidence of wound infections revealed no significant difference between groups (odds ratio of 1.03; 95% CI 0.53 to 2.0, p=0.92).

5.5 In the systematic review of 40 studies that included 3711 patients treated by SILC or CMLC, meta‑analysis of the incidence of incisional hernias revealed no significant difference between groups (odds ratio of 1.67; 95% CI 0.65 to 4.27, p=0.29).

5.6 In the systematic review of 25 randomised controlled trials that included 1841 patients treated by SILC or CMLC, meta‑analysis of the incidence of retained gallstones revealed no significant difference between groups (odds ratio of 2.15; 95% CI 0.55 to 8.33, p=0.269).

5.7 Erythema was reported in 4% (5/119) of patients in the SILC group and 0% of patients in the CMLC group in a randomised controlled trial of 200 patients (no p values reported). In the same study, ecchymosis was reported in 1% (1/119) of patients in the SILC group and 0% of patients in the CMLC group (no p values reported).

5.8 A non‑systematic review of safety events that included 38 studies (1180 patients treated by SILC) reported seroma in 1% (17/1180) of patients, renal failure in 0.08% (1/1180) of patients and ileus in 0.17% (2/1180) of patients.

5.9 Specialist advisers did not highlight any additional adverse events reported in the literature. Retained gallstones, incisional hernias, and visceral and vascular injuries (such as bile duct injuries) were identified as theoretical adverse events.