- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05384925
Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
Background & Aims:
Abnormal colonic pressure profiles have been associated with an increased risk of colonic diverticulosis. A surgical history is a known risk factor for abdominal adhesions, and these may lead to increased intraluminal colonic pressure. We assessed whether previous abdominal surgery is associated with colonic diverticulosis or diverticulitis.
Methods:
The investigators analyzed data from a prospective study of patients undergoing colonoscopy for different indications from 2020 through 2021. Patients completed a structured questionnaire concerning previous abdominal surgeries, dietary and lifestyle exposures including smoking and alcohol use, and co-morbidities.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Be'er Ya'aqov, Israel, 70300
- Asag Harofeh Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients > 18 years old who are going through colonoscopy in shamir medical center for any reason
Exclusion Criteria:
- inadequate preparation (Boston Bowel Preparation Quality Scale <6);
- previous colonic resection based on history and colonoscopy;
- previous colon cancer.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlation between prior abdominal surgery and the development of diverticulosis
Time Frame: in the end of the study (estimated in 1 year)
|
the investigators are willing to see if prior abdominal surgery raise the patient's risk of developing future diverticulosis.
The investigators use questionere to collect data from patients.
The final measurements will be calculatrd with spss software
|
in the end of the study (estimated in 1 year)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0107-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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