Actively Recruiting
Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
Led by University Hospital, Angers · Updated on 2024-06-13
630
Participants Needed
14
Research Sites
208 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
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.
CONDITIONS
Official 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 aSBO by a scanner
- Adult patient
- Beneficiary of a social security scheme
- Having signed an informed consent
You will not qualify if you...
- Indication for urgent surgery such as small intestine ischemia, intestinal pain, defense, or hemodynamic shock
- 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
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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
CONTACT
A
Aurélien Vénara, Pr
CONTACT
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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