Randomized clinical trial of the benefit of laparoscopy with closure of loop ileostomy.

BACKGROUND: The aim was to compare reversal and laparoscopy with standard reversal of loop ileostomy in terms of hospital stay and morbidity in a randomized study.
METHODS: Patients having reversal of a loop ileostomy were randomized to either standard reversal of ileostomy or reversal and laparoscopy. Strict discharge criteria were applied: toleration of two meals without nausea and vomiting, passing a bowel motion, and attaining adequate pain control with oral analgesia. Morbidity and cost were also compared between the two groups.
RESULTS: A total of 74 patients (reversal and laparoscopy 40, standard reversal 34) with a median age of 61 years underwent loop ileostomy reversal; there were 45 men (61 per cent). Ileostomy was most commonly carried out after laparoscopic low anterior resection (36 patients). Median length of stay, based on discharge criteria, was significantly shorter in the reversal and laparoscopy group than in the standard group: 4 (interquartile range 3-4) versus 5 (4-6) days (P = 0·003). The overall morbidity rate was also lower in patients who had ileostomy reversal and laparoscopy: 10 versus 32 per cent (P = 0·023). The median cost per patient was lower in the reversal and laparoscopy group: €3450 (interquartile range 2766-3450) versus €4527 (3843-7263) (P = 0·015). There was no statistically significant difference in American Society of Anesthesiologists fitness grade or time to reversal between the two groups.
CONCLUSION: Reversal of loop ileostomy with laparoscopy was associated with a shorter hospital stay, lower morbidity and reduced cost compared with the standard technique. REGISTRATION NUMBER: ISRCTN46101203 (http://www.controlled-trials.com).

RCT Entities:   Population Interventions Outcomes