NCT06151275

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

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

June 7, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

November 21, 2023

Last Update Submit

April 3, 2024

Conditions

Keywords

ColonoscopyConstipationCecal intubation time

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

  • Adenoma detection rate

    During the colonoscopy

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years old, admitted for colonoscopy

You may not qualify if:

  • Colonic resection history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Burak Dincer, MD

    Sisli Hamidiye Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

June 7, 2023

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations