National Snapshot Study Adhesive Small Bowel Obstruction (ASBO)

NCT ID: NCT03786159

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-02-28

Brief Summary

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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

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Conditions

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Surgery-Induced Tissue Adhesion Surgical Adhesions Adhesion, Tissue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Suspicion ASBO
* Age 18 years or older

Exclusion Criteria

* Clear other cause of small bowel obstruction (e.g. tumor, hernia)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard PG ten Broek, PhD, MD

Role: STUDY_DIRECTOR

Radboudumc, departement of surgery

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Pepijn Krielen, MD

Role: CONTACT

0243613808

Facility Contacts

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Pepijn Krielen

Role: primary

References

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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. doi: 10.1016/S0140-6736(98)09337-4.

Reference Type BACKGROUND
PMID: 10232313 (View on PubMed)

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. doi: 10.1007/BF02234701.

Reference Type BACKGROUND
PMID: 11391142 (View on PubMed)

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. doi: 10.1097/00000658-199603000-00003.

Reference Type BACKGROUND
PMID: 8604903 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2301905 (View on PubMed)

Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.

Reference Type BACKGROUND
PMID: 11727865 (View on PubMed)

Hershlag A, Diamond MP, DeCherney AH. Adhesiolysis. Clin Obstet Gynecol. 1991 Jun;34(2):395-402. doi: 10.1097/00003081-199106000-00023.

Reference Type BACKGROUND
PMID: 1831077 (View on PubMed)

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. doi: 10.1007/BF02237135.

Reference Type BACKGROUND
PMID: 10211502 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SnapshotASBO

Identifier Type: -

Identifier Source: org_study_id

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