Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction.

Abstract

Although conventional laparoscopic colectomy is a validated technique, laparoscopic natural-orifice specimen extraction (NOSE) colectomy might improve outcome. This randomized clinical trial compared analgesia requirements, postoperative pain, anorectal function, inflammatory response and cosmesis in laparoscopic NOSE colectomy and conventional laparoscopic colectomy. Patients were randomly assigned to undergo laparoscopic NOSE colectomy or conventional laparoscopic colectomy for left-sided colonic disease. The primary endpoint was analgesia requirement. Secondary endpoints were operative outcome, inflammatory response, anorectal function and cosmesis. Forty patients were enrolled in the study, 20 in each group (15 with diverticulitis and 5 with colorectal cancer in each group). A significant difference was observed in morphine analogue requirements (1 of 20 patients in the NOSE group versus 10 of 20 in the conventional group; P = 0·003). Patient-controlled epidural analgesia was lower in the NOSE group (mean 116 ml versus 221 ml in the conventional group; P < 0·001), as was paracetamol use (mean 11·0 versus 17·0 g respectively; P < 0·001). Postoperative pain scores were lower in the NOSE group: mean maximum visual analogue score of 3·5 versus 2·1 (P < 0·001). One week after hospital discharge, pain scores remained higher in the conventional group: 15 of 20 patients in the conventional group reported pain, compared with one of 20 in the NOSE group (P < 0·001). Inflammatory responses were greater in patients undergoing NOSE colectomy: higher peak C-reactive protein and interleukin 6 levels were observed on postoperative day 2 (P < 0·001) and day 1 (P = 0·002) respectively. Postoperative anorectal function, complications and hospital stay were similar in the two groups. Laparoscopic NOSE colectomy was associated with less pain and lower analgesia requirements than the conventional laparoscopic extraction. NCT01033838 (http://www.clinicaltrials.gov).