Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06065150

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW) | DecenTrialz