Adhesive small bowel obstruction Small bowel obstruction
Conditions
Interventions
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 refo
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:- Adult patients aged 18 years and older who have recently recovered from aSBO by conservative management for small bowel obstruction. - 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patient who are unfit for operation for surgical, anesthesiological or medical reasons as determined by multidisciplinary team assessment or pre-operative screening- Patient who has undergone surgery for previous episodes of aSBO in the past six months- Patient who has undergone previous episodes of aSBO in the past six months - Patients with active malignancy, reducing life expectancy - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is recurrence at 2 years, defined as readmission for obstructive systems with aetiology of adhesions confirmed by CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| We 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) | — |
Countries
Belgium, Netherlands
Contacts
Public ContactR.P.G. Ten Broek
Radboud Universitair Medisch Centrum
Outcome results
None listed