NCT01867528

Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction

Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (planned)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: —

Summary

Small bowel obstruction is a common reason for surgical admission. Most common reason for small bowel obstruction is adhesions, which account up to 70-80 % of small bowel obstructions. Large proportion of adhesive small bowel obstructions may be treated nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for surgical intervention is open adhesiolysis. Recently, retrospective studies have provided encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no prospective randomized trials have been carried out and retrospective series carries a high risk for patient selection and bias. Although in general laparoscopy has been associated with shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for small bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7% of patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis. The investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the hospital stay, and reduce mortality compared to open approach.

Conditions

• Adhesive Small Bowel Obstruction

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic adhesiolysis
PROCEDURE	Open adhesiolysis

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-05-01
• First posted: 2013-06-04
• Last updated: 2018-06-19

Locations

8 sites across 2 countries: Finland, Italy