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

NCT06777446 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: NL88020.091.24
• Study Type: interventional
• Target: 380
• Locations: 2 countries
• Sites: 14

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.

Conditions

Adhesive Small Bowel Obstruction

Keywords

Tissue adhesions; Adhesiolysis; Surgery

Outcome Measures

Primary Outcomes (1)

• recurrence of ASBO at 2-years of follow-up

  Recurrence is defined as a readmission for symptoms of small bowel obstruction, including lower abdominal pain, bloating and nausea with or without vomiting. In addition imaging by CT-scan should not show indications of other causes of bowel obstruction (such as an incarcerated abdominal wall hernia or tumour), which is over 90% accurate for the diagnosis of ASBO.

  2 years

Secondary Outcomes (8)

• Recurrence at 5 year

  5 years

• Recurrences needing surgery

  2 years and 5 years

• Morbidity from elective adhesiolysis

  90 days

• Health related quality of life

  2 years

• Gastro-intestinal related quality of life

  2 years

Study Arms (2)

Elective Adhesiolysis

EXPERIMENTAL

Elective adhesiolysis is a surgical procedure in which all adhesions in the abdomen are released. Elective adhesiolysis is preferably performed laparoscopy, but the precise surgical approach is adjusted to the expected location and extent of the adhesions based on factors including: presence of a stoma, abdominal wall defects, as well as the surgical history and locations of previous scarring.

Procedure: Elective Adhesionlysis; Device: Adhesion barrier

Wait-and-see policy

NO INTERVENTION

A Wait-and-see policy is the current standard of care after a non-operatively treated epsiode of ASBO. No specific intervention or follow-up is performed in the control group of wait-and-see policy.

Interventions

Elective Adhesionlysis PROCEDURE

See descriptions in study arms

Elective Adhesiolysis

Adhesion barrier DEVICE

At the end of adhesiolysis a barrier will be placed. The adhesion barrier to be used in laparoscopic adhesiolysis is Icodextrin 4% (Adepttm).

Elective Adhesiolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• KCE Belgian Healthcare Knowledge Centre: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (14)

UZ Antwerpen

Antwerp, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

UZ Brussel

Brussles, Belgium

Location

UZ Leuven (National Coordinating Center)

Leuven, Belgium

Location

Vitaz Sint-Niklaas

Sint-Niklaas, Belgium

Location

ZGT Almelo

Almelo, Netherlands

Location

OLVG Amsterdam

Amsterdam, Netherlands

Location

Maasziekenhuis Pantein Boxmeer

Boxmeer, Netherlands

Location

St. Jansdal Harderwijk

Harderwijk, Netherlands

Location

MaastrichtUMC+

Maastricht, Netherlands

Location

RadboudUMC

Nijmegen, Netherlands

Location

Laurentius Ziekenhuis Roermond

Roermond, Netherlands

Location

St. Franciscus gasthuis Rotterdam

Rotterdam, Netherlands

Location

Vie Curie Venlo

Venlo, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 37288588 BACKGROUND

• 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.

  PMID: 36691000 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Richard PG ten Broek, MD, PhD

CONTACT

+31243611111; richard.tenbroek@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter open-label randomized controlled trial

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 15, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2034
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the end of the experiment and analyses, all data will be stored for 25 years in accordance with GCP regulations.
• Access Criteria: Access to individual data will be made available upon reasonable request for academic purposes

Locations

BE (5); NL (9)