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

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05384925
• Collaborator: (none)
• Enrollment: 359
• Location: 1
• Actual Duration (Months): 23.6
• Patients Per Site Per Month: 15.2

Study Details

Study Description

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	Phase
Diverticulosis, Colonic; Abdominal Adhesion; Diverticulitis	Other: comparison

Study Design

• 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: Apr 12, 2020
• Actual Primary Completion Date: May 22, 2021
• Actual Study Completion Date: Apr 1, 2022

Outcome Measures

Primary Outcome Measures

1. correlation between prior abdominal surgery and the development of diverticulosis [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Asag Harofeh Medical Center	Be'er Ya'aqov		Israel	70300

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diverticulitis; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic

Study Results

No Results Posted as of May 26, 2022