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

NCT ID: NCT06065150

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2028-01-29

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.

Conditions

Small Bowel Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard support

Intervention Type: PROCEDURE

See arm/group descriptions

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.

Group Type: EXPERIMENTAL

Early surgery proposed according to the radiological score

Intervention Type: PROCEDURE

• 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.

Interventions

Standard support

See arm/group descriptions

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile Jaglin-Grimonprez

Role: STUDY_DIRECTOR

University hospital of Angers

Locations

University Hospital of Amiens

Amiens, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Angers

Angers, , France

Site Status: RECRUITING

University Hospital of Brest

Brest, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Tours

Chambray-lès-Tours, , France

Site Status: RECRUITING

Hospital of Haut Anjou

Château-Gontier, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Dijon Bourgogne

Dijon, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Grenoble-Alpes

Grenoble, , France

Site Status: RECRUITING

Hospital of Vendée

La Roche-sur-Yon, , France

Site Status: RECRUITING

University Hospital of Montpellier

Montpellier, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Nantes

Nantes, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Nice

Nice, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Lyon

Pierre-Bénite, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Rennes

Rennes, , France

Site Status: NOT_YET_RECRUITING

University Hospital of Strasbourg

Strasbourg, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Paul Le Naoures, Dr

Role: CONTACT

Paul.LeNaoures@chu-angers.fr

(0)2 41 35 49 16 ext. 33

Aurélien Vénara, Pr

Role: CONTACT

AuVenara@chu-angers.fr

(0)2 41 35 36 18 ext. 33

Facility Contacts

Jean-Marc REGIMBEAU, Pr

Role: primary

regimbeau.jean-marc@chu-amiens.fr

3 22 08 89 00 ext. 33

Aurélien VENARA, Pr

Role: primary

aurelien.venara@chu-angers.fr

2 41 35 49 16 ext. 33

Bogdan BADIC, Pr

Role: primary

bogdan.badic@chu-brest.fr

2 98 34 72 35 ext. 33

Mehdi OUAISSI, Pr

Role: primary

m.ouaissi@chu-tours.fr

2 18 37 05 75 ext. 33

Marine SARFATI-LEBRETON, DR

Role: primary

Marine.SarfatiLebreton@chu-angers.fr

2 43 09 33 55 ext. 33

Pablo ORTEGA DEBALLON, Pr

Role: primary

pablo.ortega-deballon@chu-dijon.fr

3 80 29 37 47 ext. 33

Edouard GIRARD, Dr

Role: primary

egirard1@chu-grenoble.fr

4 76 76 54 65 ext. 33

Emeric ABET, Dr

Role: primary

emeric.abet@ght85.fr

2 51 44 61 61 ext. 33

François-Régis SOUCHE, Pr

Role: primary

fr-souche@chu-montpellier.fr

4 67 33 70 72 ext. 33

Emilie DUCHALAIS, Dr

Role: primary

emilie.duchalais@chu-nantes.fr

2 40 08 33 33 ext. 33

Damien MASSALOU, Dr

Role: primary

massalou.d@chu-nice.fr

4 92 03 77 77 ext. 33

Guillaume PASSOT, Pr

Role: primary

guillaume.passot@chu-lyon.fr

4 78 86 23 71 ext. 33

Fabien ROBIN, Dr

Role: primary

Fabien.ROBIN@chu-rennes.fr

2 99 28 90 37 ext. 33

Cécile BRIGAND, Pr

Role: primary

cecile.brigand@chru-strasbourg.fr

3 88 12 72 26

Other Identifiers

2023-A00875-40

Identifier Type: -

Identifier Source: org_study_id