National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03786159
Collaborator
(none)
500
1
22.1
22.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Nationwide Audit of the Management of Adhesive Small Bowel Obstruction: a Snapshot Study
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Feb 1, 2021

Outcome Measures

Primary Outcome Measures

  1. 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)?

  2. 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?

  3. 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).

  4. 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.

  5. Laparoscopic surgery for ASBO [February 2021]

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

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Suspicion ASBO

  • Age 18 years or older

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radboudumc Nijmegen Gelderland Netherlands 6500HB

Sponsors and Collaborators

  • Radboud University Medical Center

Investigators

  • Study Director: Richard PG ten Broek, PhD, MD, Radboudumc, departement of surgery

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT03786159
Other Study ID Numbers:
  • SnapshotASBO
First Posted:
Dec 24, 2018
Last Update Posted:
Oct 28, 2019
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2019