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

Small Bowel Obstruction Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065150
• Other study ID #: 2023-A00875-40
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: January 29, 2028

Study information

• Verified date: June 2024
• Source: University Hospital, Angers
• Contact: Paul Le Naoures, Dr
• Phone: (0)2 41 35 49 16
• Email: Paul.LeNaoures[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: January 29, 2028
• Est. primary completion date: January 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Procedure:
• Standard support
See arm/group descriptions
• 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.

Locations

Country	Name	City	State
France	University Hospital of Amiens	Amiens
France	University Hospital of Angers	Angers
France	University Hospital of Brest	Brest
France	University Hospital of Tours	Chambray-lès-Tours
France	Hospital of Haut Anjou	Château-Gontier
France	University Hospital of Dijon Bourgogne	Dijon
France	University Hospital of Grenoble-Alpes	Grenoble
France	University Hospital of Montpellier	Montpellier
France	University Hospital of Nantes	Nantes
France	University Hospital of Nice	Nice
France	University Hospital of Lyon	Pierre-Bénite
France	University Hospital of Rennes	Rennes
France	Hospital of Vendée	Roche Sur Yon
France	University Hospital of Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morbidity and mortality at 30 days	Morbidity and mortality at 30 days of aSBO management	30 days
Secondary	Length of patient hospitalization	Time between admission and discharge from hospitalization	assessed to 2 days
Secondary	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.	one year
Secondary	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	One year
Secondary	Surgical morbidity and mortality at 30 days of patients operated on during the first hospitalization	Surgical morbidity and mortality at 30 days of aSBO management defined as the appearance of a deviation from the normal course of expected surgical outcomes between the day of hospitalization and the 30th day. Morbi-mortality is classified according to the Dindo-Clavien scale. Morbi-mortality is collected only for surgical patients, and if the episode is secondary to surgical treatment.	30 days
Secondary	Laparoscopic surgery rate	Laparoscopic surgery rate is defined as the number of surgeries performed from incision to closure by laparoscopic approach out of the total number of surgeries. The need for conversion by laparotomy will also be collected and compared between the 2 groups	Surgery time assessed to 1 hour