4 Efficacy

Guidance

This section describes efficacy 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.

4.1 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 proportion of procedures that were converted to open surgery revealed no significant difference between groups (odds ratio of 0.69; 95% confidence interval [CI] 0.13 to 3.58, p=0.655).

4.2 In the systematic review of 25 randomised controlled trials that included 1841 patients treated by SILC or CMLC, meta‑analysis of the proportion of procedures that needed an additional surgical instrument revealed an odds ratio of 7.45 in favour of CMLC (95% CI 3.82 to 14.52). The proportion of procedures that needed additional surgical instruments was significantly lower in the CMLC group (p<0.001).

4.3 In a systematic review of 40 studies that included 3711 patients treated by SILC or CMLC, meta‑analysis of intraoperative blood loss revealed no significant difference between groups (pooled mean difference of 0.44; 95% CI -0.96 to 1.85, p=0.54).

4.4 In the systematic review of 25 randomised controlled trials that included 1841 patients treated by SILC or CMLC, meta‑analysis of postoperative pain scores revealed a pooled mean difference of -0.70 in favour of SILC at 3 to 4 hours (95% CI -1.32 to -0.09). Pain scores were significantly better in the SILC group (p=0.026). At 6 to 8 hours, the pooled mean difference was -0.613 in favour of SILC (95% CI -1.077 to -0.149, p=0.01).

4.5 In the systematic review of 25 randomised controlled trials that included 1841 patients treated by SILC or CMLC, meta‑analysis of cosmesis scores at final follow‑up revealed a pooled mean difference of 1.16 in favour of SILC (95% CI 0.61 to 1.70). Cosmesis scores were significantly better in the SILC group (p<0.001).

4.6 In a randomised controlled trial of 200 patients treated by SILC (n=119) or CMLC (n=81), postoperative SF‑12 scores (ranging from 0 to 100 with higher scores indicating better outcomes) were 51.1±8.9 in the SILC group and 54.1±6.7 in the CMLC group at 1‑month follow‑up (no preoperative SF‑12 scores were reported, p=0.03).

4.7 Specialist advisers listed key efficacy outcomes as cosmesis, patient satisfaction and pain scores.