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Clinical Trials/NCT03786159
NCT03786159
Unknown
Not Applicable

Prospective Nationwide Audit of the Management of Adhesive Small Bowel Obstruction: a Snapshot Study

Radboud University Medical Center1 site in 1 country500 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery-Induced Tissue Adhesion
Sponsor
Radboud University Medical Center
Enrollment
500
Locations
1
Primary Endpoint
CT treatment ASBO
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
February 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Suspicion ASBO
  • Age 18 years or older

Exclusion Criteria

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

Outcomes

Primary Outcomes

CT treatment ASBO

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: February 2021

How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?

Study Sites (1)

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