Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis

May 22, 2022 updated by: Eran Ariam, Assaf-Harofeh Medical Center

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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

359

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Be'er Ya'aqov, Israel, 70300
        • Asag Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients 18 years of age and older presenting for a colonoscopy at Shamir Medical Center between 2020 and 2021

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2020

Primary Completion (Actual)

May 22, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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