A prospective, randomized, single-blind trial of 5-mm versus 3-mm ports for laparoscopic cholecystectomy: is smaller better?

BACKGROUND: Single-incision laparoscopic cholecystectomy (SILC) is said to provide improved cosmesis with a reduction in postoperative pain, but SILC involves a change in operative technique. A single-blind, randomized controlled trial compared cosmetic outcomes and postoperative pain between 3- and 5-mm ports used for laparoscopic cholecystectomy (LC).
METHODS: For this study, 80 patients with symptomatic gallstones were recruited from a single center and randomized to a LC using either a 5-mm port and three 3-mm ports (group A) or a 10-mm port and three 5-mm ports (group B). Operative details; pain scores at 1 h, 6 h, and 1 week; and analgesia required during the first week were collected. Cosmetic outcome was assessed at 6 months using a validated questionnaire.
RESULTS: For each group, 40 patients were recruited. The two groups were well matched except for sex. Group A had 11 males, and Group B had 4 males. The mean operative time was 49 ± 12 min (range, 24-120 min) in the 3-mm group versus 46 ± 19 min (range, 21-124 min) in the control group (p = 0.40). The two groups did not differ statistically in the day case rate. The pain scores in Group A were 2.5 ± 2.1 at 1 h, 3.2 ± 2.2 at 6 h, and 0.8 ± 2.2 at 1 week versus 4.2 ± 2.9 at 1 h, 3.3 ± 2.4 at 6 h, and 2.1 ± 2.4 at 1 week in Group B (p = 0.003, 0.63, and 0.002, respectively). No difference in the analgesia consumption was observed during the first postoperative week. The patients in Group A had significantly better cosmetic outcome scores at 6 months.
CONCLUSION: The use of 3-mm ports is technically feasible in patients undergoing LC for gallstones. The operating times are comparable with those for conventional LC, whereas the pain scores are reduced, and the cosmetic outcome is better.

RCT Entities:   Population Interventions Outcomes