Factors Predict Difficult Colonoscopy Before the Procedur... | NCT06151275

Studies
Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study

NCT06151275

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Apr 4, 2024Actual

Enrollment

915Actual

Phase

Not provided

Conditions

Colonoscopy

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Apr 2024

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

Jun 7, 2023Actual

Primary Completion Date

Apr 3, 2024Actual

Completion Date

Apr 3, 2024Actual

First Submitted Date

Nov 21, 2023

First Submission Date that Met QC Criteria

Nov 21, 2023

First Posted Date

Nov 30, 2023Actual

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

Apr 3, 2024

Last Update Posted Date

Apr 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Burak Dincer, Principal investigator, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

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

In this study, the investigators aim to evaluate the relationship between cecal intubation time during colonoscopies and factors such as the patient's age, body mass index, history of constipation, Wexner constipation score, antidepressant use, and previous abdominal surgery. The objective is to assess factors that may predict longer cecal intubation times, especially in difficult colonoscopies. Prior to the procedure, informed consent will be obtained from patients scheduled for colonoscopy in the surgical endoscopy unit, and relevant information will be recorded. During the procedure, data will be collected, including cecal intubation time, if ileal intubation is performed, and the total procedure time.

Detailed Description

This study is designed as a prospective single-center registry study and has been approved by the Ethics Committee of Sisli Hamidiye Etfal Training and Research Hospital on May 30, 2023. The inclusion criteria for study involve patients scheduled for colonoscopy in surgical endoscopy unit who have not undergone colorectal surgery. Following informed consent obtained from patients before colonoscopy, data forms prepared by investigators will be completed, evaluating patients' age, height, weight, body mass index, colonoscopy indication, antidepressant use, and history of abdominal surgeries. Additionally, the Wexner constipation score will be calculated for each patient.

The time taken to reach the cecum and, if intubated, the ileum, from the initial insertion of the endoscope in colonoscopy, as well as the total procedure time, will be recorded using a chronometer. Patients with inadequate bowel preparation preventing cecal intubation will be excluded from the study. The collected data will be analysed to assess factors prolonging cecal intubation time and, if possible, to identify predictors for difficult colonoscopy before procedure.

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

915Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colonoscopy		18-95 years old patients apply our endoscopy unit for colonoscopy will be included in our study. Patients that have colonic resection history will be excluded from study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cecal intubation rate	The rate of reaching the cecum in all colonoscopies performed	During the colonoscopy
Ileal intubation rate	The rate of reaching the terminal ileum in all colonoscopies performed	During the colonoscopy
Cecal intubation time	Time for reaching caecum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes	During the colonoscopy
Ileal intubation time	Time for reaching ileum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes	During the colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	The rate at which endoscopists find one or more adenoma during colonoscopies	During the colonoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-95 years old, admitted for colonoscopy

Exclusion Criteria:

Colonic resection history

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Patients that admit for colonoscopy to Sisli Hamidiye Etfal Research and Training Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burak Dincer, MD	Sisli Hamidiye Etfal Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisli Hamidiye Etfal Research and Training Hospital		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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