Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study

Colonoscopy Clinical Trial

Official title:

Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06151275
• Other study ID #: 30.05.2023-3951
• Status: Completed
• Start date: June 7, 2023
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 915
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• 18-95 years old, admitted for colonoscopy

Exclusion Criteria:

• Colonic resection history

Related Conditions & MeSH terms

• Colonoscopy

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cecal intubation rate	The rate of reaching the cecum in all colonoscopies performed	During the colonoscopy
Primary	Ileal intubation rate	The rate of reaching the terminal ileum in all colonoscopies performed	During the colonoscopy
Primary	Cecal intubation time	Time for reaching caecum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes	During the colonoscopy
Primary	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	Adenoma detection rate	The rate at which endoscopists find one or more adenoma during colonoscopies	During the colonoscopy