Actively Recruiting
Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: SURGI-BOW Randomized Controlled Trial
Led by University Hospital, Angers · Updated on 2024-06-13
630
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Angers
Lead Sponsor
D
Direction Générale de l'Offre de Soins
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the best management approach for uncomplicated acute small bowel obstruction (aSBO), a condition where the small intestine is blocked. Traditionally, non-surgical treatment lasting 72 hours is recommended before considering surgery, but this is only successful in about 60 to 70% of cases. Early surgery within 24 hours is being evaluated as it may reduce complications, hospital stay length, and improve surgical outcomes due to advances in laparoscopic techniques and anesthesia. The study compares two treatment strategies. One group receives standard care involving a nasogastric tube and hydration for 72 hours before surgery is considered if symptoms do not improve. The experimental group’s treatment is guided by a radiological score that predicts treatment success; patients with a high score (≥5) receive early surgery within 24 hours, starting laparoscopically with conversion to open surgery if needed. Those with a low score (<5) receive the standard 72-hour medical management. Participants are monitored daily during their hospital stay for surgery details, medical management success, gastrointestinal recovery, and any complications. Follow-up visits occur 30 and 90 days post-surgery to track morbidity, mortality, and recurrence. Additionally, participants receive a telephone follow-up at 12 months to assess any further episodes of obstruction. The primary outcome is 90-day morbidity and mortality related to the management strategy.
CONDITIONS
Brief Title
Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission for acute intestinal obstruction of the small intestine on adhesion or bridle
- Confirmation of the acute small bowel obstruction by CT scan
- Adult patient 18 years or older
- Beneficiary of a social security scheme
- Signed informed consent
You will not qualify if you...
- Indication for urgent surgery (small intestine ischemia, intestinal pain, defense, 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days for initial medical treatment or surgery within 24 hours depending on group assignment
Participants receive either early surgery within 24 hours if the radiological score is 5 or higher, or initial medical treatment including nasogastric tube placement and hydration for 3 days. Surgery may be proposed after 3 days if medical treatment fails or immediately if clinical condition deteriorates.
Daily visits from admission to discharge
Duration - 12 months
Participants have follow-up consultations at 30 and 90 days after surgery or discharge to monitor recovery, morbidity, mortality, and recurrence. Additional telephone contact occurs at 12 months to check for recurrence of acute small bowel obstruction.
2 in-person visits at 30 and 90 days and 1 telephone contact at 12 months
Trial Site Locations
Total: 14 locations
1
University Hospital of Amiens
Amiens, France, 80054
Not Yet Recruiting
2
University Hospital of Angers
Angers, France, 49933
Actively Recruiting
3
University Hospital of Brest
Brest, France, 29609
Not Yet Recruiting
4
University Hospital of Tours
Chambray-lès-Tours, France, 37170
Actively Recruiting
5
Hospital of Haut Anjou
Château-Gontier, France, 53200
Not Yet Recruiting
6
University Hospital of Dijon Bourgogne
Dijon, France, 21000
Not Yet Recruiting
7
University Hospital of Grenoble-Alpes
Grenoble, France, 38043
Actively Recruiting
8
Hospital of Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
9
University Hospital of Montpellier
Montpellier, France, 34295
Not Yet Recruiting
10
University Hospital of Nantes
Nantes, France, 44093
Not Yet Recruiting
11
University Hospital of Nice
Nice, France, 06000
Not Yet Recruiting
12
University Hospital of Lyon
Pierre-Bénite, France, 69495
Not Yet Recruiting
13
University Hospital of Rennes
Rennes, France, 35033
Not Yet Recruiting
14
University Hospital of Strasbourg
Strasbourg, France, 67098
Not Yet Recruiting
Research Team
P
Paul Le Naoures, Dr
A
Aurélien Vénara, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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