Clinical trial NCT06065150: Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
Official title: SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Bowel Obstruction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2023-10-03
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre randomized open-label controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Multicentre randomized open-label controlled trial. Patients admitted to visceral surgery for aSBO are screened and the study is offered for patients who do not meet the criteria for emergency surgery.

If they accept the study, a randomization is carried out by stratification according to (i) the sex, (ii) the center (University hospital/ Peripheral center), (iii) the number of previous episodes of aSBO (0 or ≥1 ) and the value of the radiological score (\< or ≥5).

Patients are cared for according to the strategy defined by randomisation (standard procedure vs early surgery proposed according to the radiological score). Demographic information, medical and surgical history, and treatments are collected on the day of admission.

A visit is made each day (from admission to discharge) to collect information on the surgery (if performed), on the medical management and its success or failure (if applicable), on the recovery of functions gastrointestinal, on perioperative management, on morbidity and mortality.

Patients have a follow-up consultation on D30 and D90 postoperative. Any morbidity, mortality or recurrence that occurred during this period is collected.

Patients are contacted by telephone after 12 months to ensure that no recurrence of aSBO has occurred.

Eligibility criteria: 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 outcomes:
measure: 90-day morbidity and mortality of aSBO management using the radiological score
timeFrame: 90 days
Secondary outcomes:
measure: Morbidity and mortality at 30 days
timeFrame: 30 days
measure: Length of patient hospitalization
timeFrame: assessed to 2 days
measure: Recurrence rate of aSBO
timeFrame: one year
measure: Rate of recourse to surgery for patients not operated on straight away
timeFrame: One year
measure: Surgical morbidity and mortality at 30 days of patients operated on during the first hospitalization
timeFrame: 30 days
measure: Laparoscopic surgery rate
timeFrame: Surgery time assessed to 1 hour
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital of Amiens
city: Angers
country: France
facility: University Hospital of Angers
city: Brest
country: France
facility: University Hospital of Brest
city: Chambray-lès-Tours
country: France
facility: University Hospital of Tours
city: Château-Gontier
country: France
facility: Hospital of Haut Anjou
city: Dijon
country: France
facility: University Hospital of Dijon Bourgogne
city: Grenoble
country: France
facility: University Hospital of Grenoble-Alpes
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nice
country: France
facility: University Hospital of Nice
city: Pierre-Bénite
country: France
facility: University Hospital of Lyon
city: Rennes
country: France
facility: University Hospital of Rennes
city: Roche Sur Yon
country: France
facility: Hospital of Vendée
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
Study officials:
affiliation: University hospital of Angers
name: Cécile Jaglin-Grimonprez
role: STUDY_DIRECTOR
References: