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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05384925
Recruitment Status : Completed
First Posted : May 20, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Eran Ariam, Assaf-Harofeh Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Diverticulosis, Colonic Abdominal Adhesion Diverticulitis Other: comparison

Study Design
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Study Type : Observational
Actual Enrollment : 359 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
Actual Study Start Date : April 12, 2020
Actual Primary Completion Date : May 22, 2021
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: comparison
    abdominal surgery as a risk factor for diverticulosis

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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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): NCT05384925


Locations
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Israel
Asag Harofeh Medical Center
Be'er Ya'aqov, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information
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Responsible Party: Eran Ariam, principal investigator, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT05384925    
Other Study ID Numbers: 0107-20
First Posted: May 20, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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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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Diverticulitis
Diverticulum
Diverticular Diseases
Diverticulosis, Colonic
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases