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

Last updated: June 12, 2024
Sponsor: University Hospital, Angers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intra-abdominal Infections

Ileus

Constipation

Treatment

Standard support

Early surgery proposed according to the radiological score

Clinical Study ID

NCT06065150
2023-A00875-40
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Admission for acute intestinal obstruction of the small intestine on adhesion orbridle

  • Confirmation of the aSBO by a scanner

  • Adult patient

  • Beneficiary of a social security scheme

  • Having signed an informed consent

Exclusion

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

Study Design

Total Participants: 630
Treatment Group(s): 2
Primary Treatment: Standard support
Phase:
Study Start date:
January 30, 2024
Estimated Completion Date:
January 29, 2028

Study 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.

Connect with a study center

  • Pr Jean-Marc REGIMBEAU

    Amiens,
    France

    Site Not Available

  • University Hospital of Amiens

    Amiens, 80054
    France

    Site Not Available

  • Pr Aurélien VENARA

    Angers,
    France

    Active - Recruiting

  • University Hospital of Angers

    Angers, 49933
    France

    Active - Recruiting

  • Pr Bogdan BADIC

    Brest,
    France

    Site Not Available

  • University Hospital of Brest

    Brest, 29609
    France

    Site Not Available

  • Pr Mehdi OUAISSI

    Chambray-lès-Tours,
    France

    Active - Recruiting

  • University Hospital of Tours

    Chambray-lès-Tours, 37170
    France

    Active - Recruiting

  • Dr Marine SARFATI-LEBRETON

    Château-Gontier,
    France

    Site Not Available

  • Hospital of Haut Anjou

    Château-Gontier, 53200
    France

    Site Not Available

  • Pr Pablo ORTEGA DEBALLON

    Dijon,
    France

    Site Not Available

  • University Hospital of Dijon Bourgogne

    Dijon, 21000
    France

    Site Not Available

  • Dr Edouard GIRARD

    Grenoble,
    France

    Active - Recruiting

  • University Hospital of Grenoble-Alpes

    Grenoble, 38043
    France

    Active - Recruiting

  • Pr François-Régis SOUCHE

    Montpellier,
    France

    Site Not Available

  • University Hospital of Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Dr Emilie DUCHALAIS

    Nantes,
    France

    Site Not Available

  • University Hospital of Nantes

    Nantes, 44093
    France

    Site Not Available

  • Dr Damien MASSALOU

    Nice,
    France

    Site Not Available

  • University Hospital of Nice

    Nice, 06000
    France

    Site Not Available

  • Pr Guillaume PASSOT

    Pierre-Bénite,
    France

    Site Not Available

  • University Hospital of Lyon

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Dr Fabien ROBIN

    Rennes,
    France

    Site Not Available

  • University Hospital of Rennes

    Rennes, 35033
    France

    Site Not Available

  • Dr Emeric ABET

    Roche Sur Yon,
    France

    Active - Recruiting

  • Hospital of Vendée

    Roche Sur Yon, 85925
    France

    Active - Recruiting

  • Pr Cécile BRIGAND

    Strasbourg,
    France

    Site Not Available

  • University Hospital of Strasbourg

    Strasbourg, 67098
    France

    Site Not Available

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