NCT05384925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

May 12, 2022

Last Update Submit

May 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • correlation between prior abdominal surgery and the development of diverticulosis

    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)

Interventions

abdominal surgery as a risk factor for diverticulosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • patients \> 18 years old who are going through colonoscopy in shamir medical center for any reason

You may not qualify if:

  • inadequate preparation (Boston Bowel Preparation Quality Scale \<6);
  • previous colonic resection based on history and colonoscopy;
  • previous colon cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asag Harofeh Medical Center

Be’er Ya‘aqov, 70300, Israel

Location

MeSH Terms

Conditions

Diverticulosis, ColonicDiverticulitis

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesDiverticular DiseasesGastroenteritis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 20, 2022

Study Start

April 12, 2020

Primary Completion

May 22, 2021

Study Completion

April 1, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations