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Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized,
Ville Sallinen1, Heidi Wikström, Mikael Victorzon
1Department of Abdominal Surgery, Helsinki University Central Hospital, Haartmaninkatu 4, 00029 Helsinki, Finland. ville.sallinen@helsinki.fi.
BMC Surgery
|October 13, 2014
Summary
This study is the first randomized controlled trial comparing laparoscopic adhesiolysis to open surgery for adhesive small bowel obstruction. It aims to provide level Ib evidence on the effectiveness of laparoscopic surgery for this condition.
Area of Science:
- Gastroenterology
- Surgical Innovation
- Clinical Trials
Background:
- Adhesive small bowel obstruction is a common surgical complication.
- Laparoscopic adhesiolysis is a minimally invasive alternative to open surgery.
- Previous studies suggest potential benefits of laparoscopy, but lack high-level evidence.
Purpose of the Study:
- To compare the efficacy and safety of laparoscopic adhesiolysis versus open surgery for adhesive small bowel obstruction.
- To provide level Ib evidence on the use of laparoscopy in treating this condition.
- To evaluate postoperative outcomes including hospital stay, complications, and long-term recurrence.
Main Methods:
- Multicenter, prospective, open-label, randomized controlled trial.
- 102 patients with computed-tomography diagnosed adhesive small bowel obstruction.
- Primary endpoint: length of postoperative hospital stay; Secondary endpoints: stool passage, nutrition commencement, mortality, complications, pain, sick leave; Tertiary endpoints: hernia rate, SBO recurrence.
Main Results:
- Data not yet available as this is a prospective trial description.
- The study is powered to detect a 2.5-day difference in hospital stay.
- Long-term follow-up at 1, 5, and 10 years is planned.
Conclusions:
- This trial represents the first attempt to generate level Ib evidence comparing laparoscopic and open surgery for adhesive small bowel obstruction.
- Findings will inform clinical practice regarding the optimal surgical approach.
- The study will contribute significant data to the understanding of laparoscopic adhesiolysis benefits and risks.
