The AWARE trial aims to address adhesive small bowel obstruction (aSBO), a common emergency with high morbidity and recurrence rates. Acute treatment options include conservative care or emergency surgery. Conservative treatment is preferred to avoid surgical risks but has a high recurrence rate in the long term. This study plans to compare the effectiveness of elective adhesiolysis (a procedure to remove adhesions and prevent their reformation) after conservative treatment with the standard wait-and-see approach to reduce long-term recurrence risk. The study includes 380 adult patients who recovered from aSBO without receiving surgery. Based on previous data, elective adhesiolysis is expected to reduce recurrence risk by 50%,. Secondary outcomes include complications of surgery, abdominal issues, quality of life, costs. The study’s findings could improve treatment guidelines for patients with aSBO.
| Title | AWARE trial: Elective Adhesiolysis vs. wait-and-see policy to prevent recurrence of adhesive small bowel obstruction (aSBO) |
| Participants (P) | Adult patients who recovered from aSBO by conservative treatment. Patients who are inoperable for medical, anaesthesiological or surgical reasons are excluded. |
| Intervention (I) | The investigated intervention is elective adhesiolysis, an abdominal procedure in which all adhesions are cut, and preventive measures are applied to reduce the risk of adhesion reformation. |
| Control (C) | Wait-and-see policy (the current standard treatment) |
| Outcome (O) | Primary outcome is recurrence, defined as readmission for obstructive systems with aetiology of adhesions confirmed by CT. |
| Trial Design | Multicenter open-label randomized controlled trial |
| Sample Size | 380 (120 in Belgium) |
| Trial duration | 54 months |
| Budget | 385.000€ |
| Sponsor | Radboud UMC (NL) |
| Chief Investigator | Prof. Dr. Albert Wolthuis |
| BCC | UZ Leuven |
| Number of participating sites | 15 sites (5 in BE) |
| External Partners | Baxter |
