SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospital of Amiens
NOT_YET_RECRUITING
Amiens
University Hospital of Angers
RECRUITING
Angers
University Hospital of Brest
NOT_YET_RECRUITING
Brest
University Hospital of Tours
RECRUITING
Chambray-lès-tours
Hospital of Haut Anjou
NOT_YET_RECRUITING
Château-gontier
University Hospital of Dijon Bourgogne
NOT_YET_RECRUITING
Dijon
University Hospital of Grenoble-Alpes
RECRUITING
Grenoble
Hospital of Vendée
RECRUITING
La Roche-sur-yon
University Hospital of Montpellier
NOT_YET_RECRUITING
Montpellier
University Hospital of Nantes
NOT_YET_RECRUITING
Nantes
University Hospital of Nice
NOT_YET_RECRUITING
Nice
University Hospital of Lyon
NOT_YET_RECRUITING
Pierre-bénite
University Hospital of Rennes
NOT_YET_RECRUITING
Rennes
University Hospital of Strasbourg
NOT_YET_RECRUITING
Strasbourg
Contact Information
Primary
Paul Le Naoures, Dr
Paul.LeNaoures@chu-angers.fr
(0)2 41 35 49 16
Backup
Aurélien Vénara, Pr
AuVenara@chu-angers.fr
(0)2 41 35 36 18
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2028-01-29
Participants
Target number of participants: 630
Treatments
Active_comparator: Standard support
Initial medical treatment: placement of a nasogastric tube associated with hydration and vascular filling for hypovolaemic patients. Other medical treatments for occlusive small bowel syndrome on adhesion or flange can be performed but are not systematically recommended. Their use is left to the discretion of the surgeon. Medical treatment is carried out over 72 hours from admission.~In case of resumption of a transit by gas and/or stools associated with a tolerance to the food, the exit is authorized without resorting to surgery. In the absence of a resumption of transit by gas and/or stools associated with tolerance to food, semi-urgent surgical management is proposed 72 hours from the start of management. In the event of deterioration of the clinical condition during hospitalization, urgent surgery will be proposed, according to the recommendations for use.
Experimental: Early surgery proposed according to the radiological score
Patients included in the experimental arm have treatment adapted to the radiological score. The radiological score described by Berge et al. (Berge et al. Eur J Trauma Emerg Surg 2021) is calculated after patient inclusion.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers
Collaborators: Direction Générale de l'Offre de Soins

This content was sourced from clinicaltrials.gov