Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel Obstruction

Not Applicable

Not yet recruiting

• Conditions: Adhesive Small Bowel Obstruction

• Registration Number: NCT06777446
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Rationale: Adhesive small bowel obstruction (aSBO) is a frequent surgical emergency, associated with 3-8% hospital mortality and a high risk of recurrence (20% at two years of follow-up). ASBO can be treated conservatively or by emergency surgery. In the absence of bowel ischemia or strangulation, conservative treatment is often preferred, to avoid the excess morbidity and mortality from emergency surgery. Recent epidemiological studies, however, demonstrate a considerable higher recurrence risk of aSBO after conservative treatment that is associated with hospital readmissions and lower survival. Elective adhesiolysis following successful conservative treatment might reduce these long-term risks whilst avoiding the high complication rate of emergency surgery.

Objective: The investigators aim to assess the efficacy of elective adhesiolysis following conservative treatment for aSBO as compared to the current state of the art (wait-and-see policy) to prevent long-term recurrence of aSBO. Further the investigators will evaluate quality of life, healthcare and societal costs.

Study design: Multicenter open-label randomized controlled trial, including 380 patients.

Study population: Adult patients who recovered from aSBO by conservative treatment. Patients that are inoperable for medical, anaesthesiological or surgical reasons are excluded. Intervention (if applicable): The intervention of investigation is elective adhesiolysis. Adhesiolysis is an abdominal procedure in which all adhesions are cut, and adhesion prevention applied to reduce the risk of adhesion reformation. The intervention is compared to wait-and-see policy (the current standard treatment)

Main study parameters/endpoints: Primary outcome is recurrence, defined as readmission for obstructive systems with aetiology of adhesions confirmed by CT. The investigators hypothesize a 50% reduction in recurrence in the intervention arm. Secondary outcomes are morbidity from surgery, health-related quality of life (EQ5D), healthcare costs and societal costs (iMCQ and iPCQ)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients in the intervention group are exposed to abdominal surgery, which is associated with a moderate risk of minor complications such as wound infection and haemorrhage, and a small risk of severe complications such as iatrogenic bowel injury. According to our hypothesis, a potential benefit is the reduction in the risk of recurrences. Recurrence of aSBO is associated with a risk of readmissions, reinterventions, and also increased long-term mortality.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Study Start: 2025-02
• Primary Completion: 2029-02
• Study Completion: 2034-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Adult patients aged 18 years and older who have recently recovered from aSBO by small bowel obstruction managed by conservative treatment.
• Patients who have previously been operated (high a prior risk of adhesions) are required to have no signs of other causes of bowel obstruction on imaging studies (CT-scan).
• Patients with no previous operation in history (low a prior risk of adhesions) are required to have typical signs for aSBO on imaging studies (abrupt change of bowel calibre, closed loop, or signs of torsion on vessels in the mesentery on CT-scan).

Exclusion Criteria

• Patient who are unfit for reoperation for surgical, anesthesiological or medical reasons as determined by multidisciplinary team assessment or pre-operative screening
• Patients with active malignancy, reducing life expectancy
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
recurrence of ASBO at 2-years of follow-up	2 years	Recurrence is defined as a readmission for symptoms of small bowel obstruction, including lower abdominal pain, bloating and nausea with or without vomiting. In addition imaging by CT-scan should not show indications of other causes of bowel obstruction (such as an incarcerated abdominal wall hernia or tumour), which is over 90% accurate for the diagnosis of ASBO.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	2 years and 5 years	incremental cost-effectiveness ratio, i.e. cost per QALY
Recurrence at 5 year	5 years	(identified by record linking\[BE\] or general practitioner data\[NL\])
Morbidity from elective adhesiolysis	90 days	Composite of: * Serious adverse events and complications, graded by Clavien-Dindo score.; * Intra-operative events (i.e. bowel injury), graded by ClassIntra®; * ICU admission; * Reinterventions within 90 days
Healthcare costs	2 years	measured by modified iMCQ
Recurrences needing surgery	2 years and 5 years	ASBO recurrence requiring emergency surgery
Societal costs	2 years	measured by modified iMCQ
Health related quality of life	2 years	- Health-related quality of life measured by EQ5D
Gastro-intestinal related quality of life	2 years	- Gastro-intestinal related quality of life measured by GIQLI

Trial Locations

Locations (14)

UZ Antwerpen; 🇧🇪 Antwerpen, Belgium

Hôpital Erasme; 🇧🇪 Brussels, Belgium

UZ Brussel; 🇧🇪 Brussles, Belgium

UZ Leuven (National Coordinating Center); 🇧🇪 Leuven, Belgium

Vitaz Sint-Niklaas; 🇧🇪 Sint-Niklaas, Belgium

ZGT Almelo; 🇳🇱 Almelo, Netherlands

OLVG Amsterdam; 🇳🇱 Amsterdam, Netherlands

Maasziekenhuis Pantein Boxmeer; 🇳🇱 Boxmeer, Netherlands

St. Jansdal Harderwijk; 🇳🇱 Harderwijk, Netherlands

MaastrichtUMC+; 🇳🇱 Maastricht, Netherlands

RadboudUMC; 🇳🇱 Nijmegen, Netherlands

Laurentius Ziekenhuis Roermond; 🇳🇱 Roermond, Netherlands

St. Franciscus gasthuis Rotterdam; 🇳🇱 Rotterdam, Netherlands

Vie Curie Venlo; 🇳🇱 Venlo, Netherlands