National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)

Surgical Adhesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786159
• Other study ID #: SnapshotASBO
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: February 2021

Study information

• Verified date: November 2018
• Source: Radboud University
• Contact: Pepijn Krielen, MD
• Phone: 0243613808
• Email: pepijn.krielen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspicion ASBO

• Age 18 years or older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adhesion, Tissue
• Intestinal Obstruction
• Surgery-Induced Tissue Adhesion
• Surgical Adhesions
• Tissue Adhesions

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. Erratum in: Dis Colon Rectum 1999 May;42(5):578. — View Citation

Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. Review. — View Citation

Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80. — View Citation

Hershlag A, Diamond MP, DeCherney AH. Adhesiolysis. Clin Obstet Gynecol. 1991 Jun;34(2):395-402. Review. — View Citation

Luijendijk RW, de Lange DC, Wauters CC, Hop WC, Duron JJ, Pailler JL, Camprodon BR, Holmdahl L, van Geldorp HJ, Jeekel J. Foreign material in postoperative adhesions. Ann Surg. 1996 Mar;223(3):242-8. — View Citation

Menzies D, Ellis H. Intestinal obstruction from adhesions--how big is the problem? Ann R Coll Surg Engl. 1990 Jan;72(1):60-3. — View Citation

Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT treatment ASBO	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)?	February 2021
Primary	Diagnostics ASBO	How many patients in the Netherlands presenting with adhesive small bowel obstruction have a CT-scan in their diagnostic work-up?	February 2021
Primary	Timeframe conservative trial ASBO	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).	February 2021
Primary	Conservative trial > 72 hours ASBO	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.	February 2021
Primary	Laparoscopic surgery for ASBO	How many patients that are surgically treated for ASBO in the Netherlands have laparoscopic surgery?	February 2021
Primary	Outcome laparoscopic surgery for ASBO	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.	February 2021