Objective: The aim of the study was to compare laparoscopic-assisted and open ileocolic resection for primary Crohn's disease in a randomized controlled trial.
Methods: Sixty patients were randomized for laparoscopic-assisted or open surgery. Primary outcome parameter was postoperative quality of life (QoL) during 3 months of follow-up, measured by SF-36 and GIQLI questionnaire. Secondary parameters were operating time, morbidity, hospital stay, postoperative morphine requirement, pain, and costs.
Results: Patient characteristics were not different. Conversion rate was 10% (n=3). Median operating time was longer in laparoscopic compared with open surgery (115 versus 90 minutes; P<0.003). Hospital stay was shorter in the laparoscopic group (5 versus 7 days; P=0.008). The number of patients with postoperative morbidity within the first 30 days differed between the laparoscopic and open group (10% versus 33%; P=0.028). There was no statistically significant difference in QoL between the groups during follow-up. Significant time effects were found on all scales of the SF-36 (P<0.001) and the GIQLI score (P<0.001). QoL declined in the first week, returned to baseline levels after 2 weeks, and was improved 4 weeks and 3 months after surgery. Median overall costs during the 3 months follow-up were significantly different: euro6412 for laparoscopic and euro8196 for open surgery (P=0.042).
Conclusions: Although QoL measured by SF-36 and GIQLI questionnaires was not different for laparoscopic-assisted compared with the open ileocolic resection, morbidity, hospital stay, and costs were significantly lower.