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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard support

    Procedure/Surgery

    See arm/group descriptions

  • Early surgery proposed according to the radiological score

    Procedure/Surgery

    * 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.

Treatment groups

630 Participants
are divided into 2 treatment groups
Group A: Standard supportActive comparator 1 intervention
Group B: Early surgery proposed according to the radiological scoreExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

90-day morbidity and mortality of aSBO management using the radiological score

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).

Time frame
90 days

Secondary outcomes

1

Morbidity and mortality at 30 days

Morbidity and mortality at 30 days of aSBO management

Time frame
30 days
2

Length of patient hospitalization

Time between admission and discharge from hospitalization

Time frame
assessed to 2 days
3

Recurrence rate of aSBO

Recurrence rate of aSBO after the episode. Recurrence is defined by any admission of the patient for nausea/vomiting and absence of flatulence and stools with a CT scan showing distension of the small intestine within one year of admission.

Time frame
one year
4

Rate of recourse to surgery for patients not operated on straight away

Recourse to surgery is defined by a surgical intervention carried out for the treatment of aSBO

Time frame
One year

Other outcomes

Sponsors and contacts

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University Hospital, Angers

Lead sponsor

Direction Générale de l'Offre de Soins

Collaborator