Comparing early surgery to 3 days of non-surgical management for acute small bowel obstruction
SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study
This study is testing whether early surgery or a 3-day wait-and-see approach is better for helping people with a blocked small intestine recover and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 14 sites (Amiens and 13 other locations) |
| Trial ID | NCT06065150 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial evaluates the effectiveness of early surgical intervention versus a standard 72-hour non-surgical management approach for patients with uncomplicated acute small bowel obstruction (aSBO). Patients who meet the inclusion criteria will be randomly assigned to either receive standard care or early surgery based on their radiological score. The study aims to assess outcomes such as recovery of gastrointestinal function, morbidity, and mortality rates, with follow-up consultations at 30 and 90 days post-operation. Data will be collected daily during hospitalization and through telephone follow-ups after 12 months to monitor for any recurrence of aSBO.
Who should consider this trial
Good fit: Ideal candidates are adults admitted for acute small bowel obstruction without indications for urgent surgery.
Not a fit: Patients requiring immediate surgical intervention due to complications like ischemia or hemodynamic shock will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients with acute small bowel obstruction.
How similar studies have performed: While there is a lack of extensive studies on this specific approach, recent literature suggests that early surgical treatment may reduce morbidity and mortality, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admission for acute intestinal obstruction of the small intestine on adhesion or bridle * Confirmation of the aSBO by a scanner * Adult patient * Beneficiary of a social security scheme * Having signed an informed consent Exclusion Criteria: * Indication for urgent surgery (small intestine ischemia, intestinal pain, defence, hemodynamic shock, etc.) * Pregnancy or breastfeeding * Poor understanding of the French language * Person deprived of liberty by judicial or administrative decision * Person undergoing psychiatric treatment under duress * Person subject to a legal protection measure * Person unable to express consent
Where this trial is running
Amiens and 13 other locations
- University Hospital of Amiens — Amiens, France (Not_yet_recruiting)
- University Hospital of Angers — Angers, France (Recruiting)
- University Hospital of Brest — Brest, France (Not_yet_recruiting)
- University Hospital of Tours — Chambray-lès-Tours, France (Recruiting)
- Hospital of Haut Anjou — Château-Gontier, France (Not_yet_recruiting)
- University Hospital of Dijon Bourgogne — Dijon, France (Not_yet_recruiting)
- University Hospital of Grenoble-Alpes — Grenoble, France (Recruiting)
- Hospital of Vendée — La Roche-sur-Yon, France (Recruiting)
- University Hospital of Montpellier — Montpellier, France (Not_yet_recruiting)
- University Hospital of Nantes — Nantes, France (Not_yet_recruiting)
- University Hospital of Nice — Nice, France (Not_yet_recruiting)
- University Hospital of Lyon — Pierre-Bénite, France (Not_yet_recruiting)
- University Hospital of Rennes — Rennes, France (Not_yet_recruiting)
- University Hospital of Strasbourg — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Paul Le Naoures, Dr
- Email: Paul.LeNaoures@chu-angers.fr
- Phone: (0)2 41 35 49 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.