Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
Recruiting now · Not applicable
Conditions studied: Small Bowel Obstruction
In brief
For uncomplicated acute small bowel obstruction (aSBO), the "Bologna guidelines" recommend non-surgical management of 72 hours before considering surgery. This treatment is based on the placement of a nasogastric tube and the correction of hydro-electrolyte disorders. Non-surgical management is only effective in 60 to 70% and surgery is therefore necessary in 30 to 40% of cases after medical treatment for at least 3 days. This therefore leads to an increase in the length of hospital stay. Some authors also point out that postponing surgery for 3 days would aggravate the morbidity and mortality of surgery. Indeed, aSBO surgery has a complication rate of 10-40% and a mortality of up to 4%. There is a lack of studies evaluating what is the best management strategy for aSBO, especially with regard to the duration of medical treatment. Many recent studies plead in favor of early surgical treatment (\<24 hours) which would reduce the morbidity and mortality rate of surgery but also the overall cost of treatment by reducing the length of stay. This paradigm shift is linked to the improvement of anesthetic and intensive care management over the last few years, but also to the advent of laparoscopy in emergency surgery. Indeed, laparoscopy could reduce the duration of hospitalization but also the operative morbidity and mortality. However, this surgical approach is not feasible in all situations and the conversion rate is reported in 30 to 76% of cases. One of the factors favoring the feasibility of the laparoscopic approach is the performance of early surgery. Another parameter favoring the feasibility of the laparoscopic approach is the aSBO mechanism: an aSBO on flange (SBA) is more likely to be treated effectively by laparoscopic than an aSBO on multiple adhesions (MA). In the literature, there is little to differentiate SBAs from MAs. Advances in CT scans have made it possible to describe the signs associated with the SBA mechanism and then to propose a score making it possible to predict the SBA mechanism with good performance (sensitivity 67.6%, specificity 84.6%). This score not only has the advantage of predicting the mechanism of the occlusion but it also makes it possible to predict the failure of non-surgical treatment if the score is ≥5.
Key facts
- Study ID
- NCT06065150
- Run by
- University Hospital, Angers
- People needed
- 630
- Starts
- 2024-01-30
- Expected to finish
- 2028-01-29
- Last updated by the study team
- 2024-06-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- University Hospital of Grenoble-Alpes — Grenoble, France (enrolling)
- Hospital of Vendée — La Roche-sur-Yon, France (enrolling)
- University Hospital of Tours — Chambray-lès-Tours, France (enrolling)
- University Hospital of Angers — Angers, France (enrolling)
- University Hospital of Brest — Brest, France
- University Hospital of Nice — Nice, France
- University Hospital of Lyon — Pierre-Bénite, France
- University Hospital of Rennes — Rennes, France
- University Hospital of Strasbourg — Strasbourg, France
- University Hospital of Amiens — Amiens, France
- University Hospital of Nantes — Nantes, France
- Hospital of Haut Anjou — Château-Gontier, France
- University Hospital of Dijon Bourgogne — Dijon, France
- University Hospital of Montpellier — Montpellier, France
Full record on ClinicalTrials.gov
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