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

Официальное название

SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Standard support
  See arm/group descriptions
• Процедура 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.

Первичные конечные точки

• 90-day morbidity and mortality of aSBO management using the radiological score [Срок оценки: 90 days]

Вторичные конечные точки (6)

• Morbidity and mortality at 30 days [Срок оценки: 30 days]
• Length of patient hospitalization [Срок оценки: assessed to 2 days]
• Recurrence rate of aSBO [Срок оценки: one year]
• Rate of recourse to surgery for patients not operated on straight away [Срок оценки: One year]
• Surgical morbidity and mortality at 30 days of patients operated on during the first hospitalization [Срок оценки: 30 days]
• Laparoscopic surgery rate [Срок оценки: Surgery time assessed to 1 hour]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 14 центров

• University Hospital of Amiens — Amiens
• University Hospital of Angers — Angers
• University Hospital of Brest — Brest
• University Hospital of Tours — Chambray-lès-Tours
• Hospital of Haut Anjou — Château-Gontier
• University Hospital of Dijon Bourgogne — Dijon
• University Hospital of Grenoble-Alpes — Grenoble
• Hospital of Vendée — La Roche-sur-Yon
• … и ещё 6 центров

Идентификаторы

NCT: NCT06065150 · 2023-A00875-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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