Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
SURGI-BOW
SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study
1 other identifier
interventional
630
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 3, 2023
CompletedStudy Start
First participant enrolled
January 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 29, 2028
June 13, 2024
June 1, 2024
3 years
September 13, 2023
June 12, 2024
Conditions
Outcome Measures
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).
90 days
Secondary Outcomes (6)
Morbidity and mortality at 30 days
30 days
Length of patient hospitalization
assessed to 2 days
Recurrence rate of aSBO
one year
Rate of recourse to surgery for patients not operated on straight away
One year
Surgical morbidity and mortality at 30 days of patients operated on during the first hospitalization
30 days
- +1 more secondary outcomes
Study Arms (2)
Standard support
ACTIVE COMPARATORInitial 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.
Early surgery proposed according to the radiological score
EXPERIMENTALPatients 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.
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University Hospital of Amiens
Amiens, 80054, France
University Hospital of Angers
Angers, 49933, France
University Hospital of Brest
Brest, 29609, France
University Hospital of Tours
Chambray-lès-Tours, 37170, France
Hospital of Haut Anjou
Château-Gontier, 53200, France
University Hospital of Dijon Bourgogne
Dijon, 21000, France
University Hospital of Grenoble-Alpes
Grenoble, 38043, France
Hospital of Vendée
La Roche-sur-Yon, 85925, France
University Hospital of Montpellier
Montpellier, 34295, France
University Hospital of Nantes
Nantes, 44093, France
University Hospital of Nice
Nice, 06000, France
University Hospital of Lyon
Pierre-Bénite, 69495, France
University Hospital of Rennes
Rennes, 35033, France
University Hospital of Strasbourg
Strasbourg, 67098, France
Study Officials
- STUDY DIRECTOR
Cécile Jaglin-Grimonprez
University hospital of Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- non applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2023
First Posted
October 3, 2023
Study Start
January 30, 2024
Primary Completion (Estimated)
January 29, 2027
Study Completion (Estimated)
January 29, 2028
Last Updated
June 13, 2024
Record last verified: 2024-06