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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| KCE Belgian Healthcare Knowledge Centre | UNKNOWN |
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective Adhesionlysis | Procedure | See descriptions in study arms |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence at 5 year | (identified by record linking[BE] or general practitioner data[NL]) | 5 years |
| Recurrences needing surgery | ASBO recurrence requiring emergency surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard PG ten Broek, MD, PhD | Contact | +31243611111 | richard.tenbroek@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerpen | Antwerp | Belgium |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37288588 | Background | 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. | |
| 36691000 |
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At the end of the experiment and analyses, all data will be stored for 25 years in accordance with GCP regulations.
Access to individual data will be made available upon reasonable request for academic purposes
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Multicenter open-label randomized controlled trial
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| 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). |
|
| 2 years and 5 years |
| Morbidity from elective adhesiolysis | Composite of:
| 90 days |
| Health related quality of life | - Health-related quality of life measured by EQ5D | 2 years |
| Gastro-intestinal related quality of life | - Gastro-intestinal related quality of life measured by GIQLI | 2 years |
| Healthcare costs | measured by modified iMCQ | 2 years |
| Societal costs | measured by modified iMCQ | 2 years |
| Cost-effectiveness | incremental cost-effectiveness ratio, i.e. cost per QALY | 2 years and 5 years |
| Hôpital Erasme | Brussels | Belgium |
|
| UZ Brussel | Brussles | Belgium |
|
| UZ Leuven (National Coordinating Center) | Leuven | Belgium |
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| Vitaz Sint-Niklaas | Sint-Niklaas | Belgium |
|
| ZGT Almelo | Almelo | Netherlands |
|
| OLVG Amsterdam | Amsterdam | Netherlands |
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| Maasziekenhuis Pantein Boxmeer | Boxmeer | Netherlands |
|
| St. Jansdal Harderwijk | Harderwijk | Netherlands |
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| MaastrichtUMC+ | Maastricht | Netherlands |
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| RadboudUMC | Nijmegen | Netherlands |
|
| Laurentius Ziekenhuis Roermond | Roermond | Netherlands |
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| St. Franciscus gasthuis Rotterdam | Rotterdam | Netherlands |
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| Vie Curie Venlo | Venlo | Netherlands |
|
| 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. |
| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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