Ireland
--:--IST
Recruiting Not applicable

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

NCT06065150 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-01-30
Last updated
2024-06-13

Condition(s) studied

Small Bowel Obstruction

Investigational drug(s) / intervention(s)

Standard supportEarly surgery proposed according to the radiological score

Standard support: See arm/group descriptions

Early surgery proposed according to the radiological score: * If score ≥ 5: the risk of medical treatment failure is multiplied by 2.9 (Feuerstoss F et al, J Gastrointest Surg 2021). Early surgical treatment is proposed; that is, the procedure is performed within 24 hours of admission. The surgery is initiated by laparoscopy and converted to open surgery if necessary. * If score \< 5: the risk of medical treatment failure is reduced. Initial medical treatment is therefore offered in accordance with standard management.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 90-day morbidity and mortality of aSBO management using the radiological score — 90 days
    The main objective is to evaluate the effectiveness, in terms of 90-day morbidity and mortality, of management of uncomplicated aSBO based on the use of the radiological score as a tool to select patients eligible for early surgery. compared to standard care (medical treatment for 72 hours).

Trial sites (14)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06065150 on ClinicalTrials.gov ↗ ← All trials in France