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Adhesive Small Bowel ObstructionAWARENCT06777446

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

A study testing Elective Adhesionlysis and Adhesion barrier in people with Adhesive Small Bowel Obstruction, run by Radboud University Medical Center at 14 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adhesive Small Bowel Obstruction
What is being tested?
Elective Adhesionlysis and Adhesion barrier
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
14 sitesin 2 countries
Study dates
Feb 2025to Feb 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Richard PG ten Broek, MD, PhD contact

+31243611111

richard.tenbroek@radboudumc.nl

14 sites in 2 countries

Netherlands9 sites

  • ZGT Almelo

    Almelo

    Esther van den Ende, MD, PhD, +3188 708 7878, e.vdende@zgt.nl

  • OLVG Amsterdam

    Amsterdam

    Steve de Castro, MD, PhD, +3120 599 9111, s.m.m.decastro@olvg.nl

  • Maasziekenhuis Pantein Boxmeer

    Boxmeer

    Klaas Govaert, MD, PhD, +31485 845 000, k.govaert@pantein.nl

  • St. Jansdal Harderwijk

    Harderwijk

    Caroline Andeweg, MD, PhD, +31 341 463 911, cs.andeweg@stjansdal.nl

  • MaastrichtUMC+

    Maastricht

    Tim Lubbers, MD, PhD, +3143 387 6543, tim.lubbers@mumc.nl

  • RadboudUMC

    Nijmegen

    Richard PG ten Broek, MD, PhD, +31243611111, richard.tenbroek@radboudumc.nl

  • Laurentius Ziekenhuis Roermond

    Roermond

    Jeroen Heemskerk, MD, PhD, +31475 382 222, jeroen.heemskerk@LZR.nl

  • St. Franciscus gasthuis Rotterdam

    Rotterdam

    Eva Deerenberg, MD, PhD, +3110 461 6161, e.deerenberg@franciscus.nl

  • Vie Curie Venlo

    Venlo

    Frits Aarts, MD, PhD, +3177 320 5555, faarts@viecuri.nl

Other trials in Netherlands

Belgium5 sites

  • UZ Antwerpen

    Antwerp

    Michiel de Maat, MD, PhD, +32 3 821 30 00, michiel.demaat@uza.be

  • Hôpital Erasme

    Brussels

    Nalja Bachir, MD, PhD, +32 2 555 31 11, najla.bachir@hubruxelles.be

  • UZ Brussel

    Brussles

    Jasper Stijns, MD, PhD, +32 2 477 41 11, jasper.stijns@uzbrussel.be

  • UZ Leuven (National Coordinating Center)

    Leuven

    Albert Wolthuis, Prof, MD, PhD, +32 16 33 22 11, albert.wolthuis@uzleuven.be

  • Vitaz Sint-Niklaas

    Sint-Niklaas

    Jean-Baptiste Cornille, MD, PhD, +323 760 60 60, cornillejb@gmail.com

Other trials in Belgium

About this study

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.

Read more

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.

Being tested
Elective Adhesionlysis, Adhesion barrier
Keywords
Tissue adhesions, Adhesiolysis, Surgery
Medical subject headings
Tissue Adhesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elective AdhesionlysisProcedure or surgery

    See descriptions in study arms

  • Adhesion barrierDevice

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

Study groups in NCT06777446
Study groupRoleWhat they receive
Elective AdhesiolysisExperimentalElective 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.
Receives: Procedure: Elective Adhesionlysis; Device: Adhesion barrier
Wait-and-see policyNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (8)

  1. Recurrence at 5 year

    (identified by record linking[BE] or general practitioner data[NL])

    Measured: 5 years

  2. Recurrences needing surgery

    ASBO recurrence requiring emergency surgery

    Measured: 2 years and 5 years

  3. Morbidity from elective adhesiolysis

    Composite of:

    • Serious adverse events and complications, graded by Clavien-Dindo score.
    • Intra-operative events (i.e. bowel injury), graded by ClassIntra®
    • ICU admission
    • Reinterventions within 90 days

    Measured: 90 days

  4. Health related quality of life

    • Health-related quality of life measured by EQ5D

    Measured: 2 years

  5. Gastro-intestinal related quality of life

    • Gastro-intestinal related quality of life measured by GIQLI

    Measured: 2 years

  6. Healthcare costs

    measured by modified iMCQ

    Measured: 2 years

  7. Societal costs

    measured by modified iMCQ

    Measured: 2 years

  8. Cost-effectiveness

    incremental cost-effectiveness ratio, i.e. cost per QALY

    Measured: 2 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter open-label randomized controlled trial
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06777446
Sponsor's protocol ID
NL88020.091.24
Acronym
AWARE
Status last verified
Dec 2024
First submitted
30 Dec 2024
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 37288588

  • 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.

    PubMed 36691000

Questions about this trial

What is this clinical trial studying?

A study testing Elective Adhesionlysis and Adhesion barrier in people with Adhesive Small Bowel Obstruction, run by Radboud University Medical Center at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Richard PG ten Broek, MD, PhD (+31243611111, richard.tenbroek@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence of ASBO at 2-years of follow-up (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06777446, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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