Clinical trial NCT06777446: Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel Obstruction
Official title: Elective Adhesiolysis vs. a Wait-and-see Policy to Prevent Recurrences After Conservative Treatment of Adhesive Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adhesive Small Bowel Obstruction
Keywords: Tissue adhesions
Adhesiolysis
Surgery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: KCE Belgian Healthcare Knowledge Centre
name: Baxter Healthcare Corporation
First posted: 2025-01-15
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter open-label randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: recurrence of ASBO at 2-years of follow-up
timeFrame: 2 years
Secondary outcomes:
measure: Recurrence at 5 year
timeFrame: 5 years
measure: Recurrences needing surgery
timeFrame: 2 years and 5 years
measure: Morbidity from elective adhesiolysis
timeFrame: 90 days
measure: Health related quality of life
timeFrame: 2 years
measure: Gastro-intestinal related quality of life
timeFrame: 2 years
measure: Healthcare costs
timeFrame: 2 years
measure: Societal costs
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years and 5 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussles
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven (National Coordinating Center)
city: Sint-Niklaas
country: Belgium
facility: Vitaz Sint-Niklaas
city: Almelo
country: Netherlands
facility: ZGT Almelo
city: Amsterdam
country: Netherlands
facility: OLVG Amsterdam
city: Boxmeer
country: Netherlands
facility: Maasziekenhuis Pantein Boxmeer
city: Harderwijk
country: Netherlands
facility: St. Jansdal Harderwijk
city: Maastricht
country: Netherlands
facility: MaastrichtUMC+
city: Nijmegen
country: Netherlands
facility: RadboudUMC
city: Roermond
country: Netherlands
facility: Laurentius Ziekenhuis Roermond
city: Rotterdam
country: Netherlands
facility: St. Franciscus gasthuis Rotterdam
city: Venlo
country: Netherlands
facility: Vie Curie Venlo
Study officials:
References:
citation: Krielen P, Kranenburg LPA, Stommel MWJ, Bouvy ND, Tanis PJ, Willemsen JJ, Migchelbrink J, de Ree R, Bormans EMG, van Goor H, Ten Broek RPG; ASBO Snapshot Study Group. Variation in the management of adhesive small bowel obstruction in the Netherlands: a prospective cross-sectional study. Int J Surg. 2023 Aug 1;109(8):2185-2195. doi: 10.1097/JS9.0000000000000471.
citation: van den Beukel BAW, Toneman MK, van Veelen F, van Oud-Alblas MB, van Dongen K, Stommel MWJ, van Goor H, Ten Broek RPG. Elective adhesiolysis for chronic abdominal pain reduces long-term risk of adhesive small bowel obstruction. World J Emerg Surg. 2023 Jan 23;18(1):8. doi: 10.1186/s13017-023-00477-9.