NCT06777446

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adhesive Small Bowel Obstruction

Interventions

Type	Name	Description
PROCEDURE	Elective Adhesionlysis	See descriptions in study arms
DEVICE	Adhesion barrier	At the end of adhesiolysis a barrier will be placed. The adhesion barrier to be used in laparoscopic adhesiolysis is Icodextrin 4% (Adepttm).

Timeline

• Start date: 2025-02-01
• Primary completion: 2029-02-01
• Completion: 2034-02-01
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

14 sites across 2 countries: Belgium, Netherlands

Regulatory

• FDA-regulated device study