An interventional study of Elective Adhesionlysis and Adhesion barrier in Adhesive Small Bowel Obstruction, sponsored by Radboud University Medical Center. Not yet recruiting at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
Among 14 studies in Tissue Adhesions with a site in Netherlands — 4 open to participants now, 5 under way, none of them phase 3. Tissue Adhesions · Netherlands.
Among the 14 studies in Tissue Adhesions with a site in Netherlands, this one is the only one that started in 2025, is one of 2 with no phase, and was the 13th registered.
121 studies on the registry are indexed under Tissue Adhesions; 15 are open to participants now.
This study's planned enrollment of 380 is above the median of 61 across 84 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →4 of the 14 studies in Tissue Adhesions with a site in Netherlands are open now, in 2 countries. Each count lists the studies.
Of the 6 Tissue Adhesions studies recruiting now, 2 (33%) set no upper age limit and 3 (50%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2025.
Median enrollment 255 across the 4 interventional studies, 141 across the 10 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
1 of 14 have an industry lead sponsor. The 6 most frequent:
Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Radboud University Medical Center has 9 studies filed under Tissue Adhesions — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Tissue Adhesions with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
See descriptions in study arms
At the end of adhesiolysis a barrier will be placed. The adhesion barrier to be used in laparoscopic adhesiolysis is Icodextrin 4% (Adepttm).
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.
Time frame: 2 years
Recurrence at 5 year
(identified by record linking\[BE\] or general practitioner data\[NL\])
Time frame: 5 years
Recurrences needing surgery
ASBO recurrence requiring emergency surgery
Time frame: 2 years and 5 years
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
Time frame: 90 days
Health related quality of life
- Health-related quality of life measured by EQ5D
Time frame: 2 years
Gastro-intestinal related quality of life
- Gastro-intestinal related quality of life measured by GIQLI
Time frame: 2 years
Healthcare costs
measured by modified iMCQ
Time frame: 2 years
Societal costs
measured by modified iMCQ
Time frame: 2 years
Cost-effectiveness
incremental cost-effectiveness ratio, i.e. cost per QALY
Time frame: 2 years and 5 years
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
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
Start is estimated for Feb 2025; primary completion for Feb 2029, 48 months later.
Of 35 interventional studies with no phase under Tissue Adhesions, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radboud University Medical Center →