Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| 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€ |
Trial team
| 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 |
