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National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)

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ClinicalTrials.gov Identifier: NCT03786159
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Radboud University

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
Surgery-Induced Tissue Adhesion Surgical Adhesions Adhesion, Tissue Other: No intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Prospective Nationwide Audit of the Management of Adhesive Small Bowel Obstruction: a Snapshot Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. 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)?

  2. 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?

  3. 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).

  4. 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.

  5. Laparoscopic surgery for ASBO [ Time Frame: February 2021 ]
    How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients with a suspicion of ASBO, older than 17 years, can be included in the present snapshot study. Patients with an episode of small bowel obstruction that is certainly not caused by adhesions fall outside of the scope of this study (eg. tumor as cause of SBO).
Criteria

Inclusion Criteria:

  • Suspicion ASBO
  • Age 18 years or older

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786159


Contacts
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Contact: Pepijn Krielen, MD 0243613808 pepijn.krielen@radboudumc.nl

Sponsors and Collaborators
Radboud University
Investigators
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Study Director: Richard PG ten Broek, PhD, MD Radboudumc, departement of surgery
  Study Documents (Full-Text)

Documents provided by Radboud University:

Additional Information:

Publications:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03786159     History of Changes
Other Study ID Numbers: SnapshotASBO
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tissue Adhesions
Intestinal Obstruction
Cicatrix
Fibrosis
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases