National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)

• Conditions: Surgery-Induced Tissue Adhesion; Surgical Adhesions; Adhesion, Tissue

• Registration Number: NCT03786159
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Over 63-90% of patients develop peritoneal adhesions after abdominal or pelvic surgery. Which makes it the most common complication after abdominal or pelvic surgery. Adhesions comprise a lifelong risk of adhesion related complications.The most frequent emergency complication of adhesion is an episode of adhesive small bowel obstruction (ASBO). Over 1 in 5 patients experiences at least 1 episode of ASBO in the 10 years following initial abdominal surgery. Despite the high incidence of ASBO, diagnosis and treatment of an episode of ASBO varies greatly between hospitals and even between doctors. Until now, optimal treatment patterns are unknown. The aim of this study is mapping of care for patients with a suspected episode of ASBO. With the collected data new hypothesis will be generated for the ideal diagnostic and therapeutic workflow for patients with a suspicion of an episode of ASBO.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-04-01
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-28
• Primary Completion: 2020-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Suspicion ASBO
• Age 18 years or older

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Exclusion Criteria

• Clear other cause of small bowel obstruction (e.g. tumor, hernia)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CT treatment ASBO	February 2021	In how many patients does CT-scan impact initial management of ASBO (i.e. different cause of SBO found, or conservative trial vs. direct surgery)?
Diagnostics ASBO	February 2021	How many patients in the Netherlands presenting with adhesive small bowel obstruction have a CT-scan in their diagnostic work-up?
Outcome laparoscopic surgery for ASBO	February 2021	What are the outcomes of laparoscopic surgery for ASBO? Days of in hospital stay, postoperative complications (Clavien-Dindo) and 90-day readmissions rates will be compared between patients who underwent open or laparoscopic surgery for ASBO.
Timeframe conservative trial ASBO	February 2021	How long do Dutch surgeons continue a conservative trial in patients with persistent obstruction who are not clinically deteriorating? Outcome measures will be based on data from the online Case Report Form (CRF).
Conservative trial > 72 hours ASBO	February 2021	Does continuing a conservative trial for more than 72 hours adverse impact final outcomes? Complications as measured by Clavien-Dindo will be registered and compared between groups.
Laparoscopic surgery for ASBO	February 2021	How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands