Laparoscopic-assisted versus open ileocolic resection for Crohn's disease: a randomized trial

Abstract

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.

Figures

FIGURE 1. Trial flow diagram.

FIGURE 2. Results of postoperative pain measured with VAS scores (mean ± 2 SEM). The x-axis represents the time when the VAS scores were taken after surgery. The gray bars represent the laparoscopic group; the black bars represent the open group.

FIGURE 3. Results of postoperative quality of life measured with SF-36 questionnaire for subscales physical function and bodily pain and the GIQLI questionnaire. The x-axis represents the time when the questionnaires were done, before and after surgery. The gray bars represent the laparoscopic group; the black bars represent the open group.