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OpenTrials
Completed

NCT Number: NCT06151275

Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli Hamidiye Etfal Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-95 years old, admitted for colonoscopy

Exclusion criteria

  • Colonic resection history

Treatment and study plan

Primary outcomes

  1. Cecal intubation rate

    Time frame: During the colonoscopy

    The rate of reaching the cecum in all colonoscopies performed

  2. Ileal intubation rate

    Time frame: During the colonoscopy

    The rate of reaching the terminal ileum in all colonoscopies performed

  3. Cecal intubation time

    Time frame: During the colonoscopy

    Time for reaching caecum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes

  4. Ileal intubation time

    Time frame: During the colonoscopy

    Time for reaching ileum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes

Secondary outcomes

  1. Adenoma detection rate

    Time frame: During the colonoscopy

    The rate at which endoscopists find one or more adenoma during colonoscopies

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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