Prior Abdominal Surgery: A Potential Risk Factor for Colo... | NCT05384925

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

NCT05384925

Sponsor

Assaf-Harofeh Medical Center

Status

Completed

Last Update Posted

May 26, 2022Actual

Enrollment

359Actual

Phase

Not provided

Conditions

Diverticulosis, Colonic
Abdominal Adhesion
Diverticulitis

Interventions

comparison

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2020Actual

Primary Completion Date

May 22, 2021Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

May 12, 2022

First Submission Date that Met QC Criteria

May 17, 2022

First Posted Date

May 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2022

Last Update Posted Date

May 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

359Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
comparison	Other	abdominal surgery as a risk factor for diverticulosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asag Harofeh Medical Center		Be’er Ya‘aqov		70300	Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043963	Diverticulosis, Colonic
D004238	Diverticulitis

Ancestor Terms

ID	Term
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided