Clinical trial NCT06151275: Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study
Official title: Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Keywords: Colonoscopy
Constipation
Cecal intubation time
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that admit for colonoscopy to Sisli Hamidiye Etfal Research and Training Hospital

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.

Eligibility criteria: Inclusion Criteria:

* 18-95 years old, admitted for colonoscopy

Exclusion Criteria:

* Colonic resection history

Primary outcomes:
measure: Cecal intubation rate
timeFrame: During the colonoscopy
measure: Ileal intubation rate
timeFrame: During the colonoscopy
measure: Cecal intubation time
timeFrame: During the colonoscopy
measure: Ileal intubation time
timeFrame: During the colonoscopy
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: During the colonoscopy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Research and Training Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Burak Dincer, MD
role: PRINCIPAL_INVESTIGATOR
References: