ColonoscopyNCT06151275
Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study
An observational study of Colonoscopy, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- How many people
- 915 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2023to 3 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that admit for colonoscopy to Sisli Hamidiye Etfal Research and Training Hospital
Who may be able to join
- 18-95 years old, admitted for colonoscopy
Who cannot join
- Colonic resection history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Research and Training Hospital
Istanbul
About this 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.
Read the 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.
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy, Constipation, Cecal intubation time
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation rate
The rate of reaching the cecum in all colonoscopies performed
Measured: During the colonoscopy
Ileal intubation rate
The rate of reaching the terminal ileum in all colonoscopies performed
Measured: During the colonoscopy
Cecal intubation time
Time for reaching caecum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes
Measured: During the colonoscopy
Ileal intubation time
Time for reaching ileum starting from endoscope insertion, this time will recorded by chronometer and recorded as minutes
Measured: During the colonoscopy
Secondary outcomes (1)
Adenoma detection rate
The rate at which endoscopists find one or more adenoma during colonoscopies
Measured: During the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start7 Jun 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Dincer, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Burak Dincer, MD, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151275
- Sponsor's protocol ID
- 30.05.2023-3951
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predict Difficult Colonoscopy Before the Procedure: Prospective Registry Study
- ClinicalTrials.gov ID
- NCT06151275
- Acronym / sponsor ID
- 30.05.2023-3951
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy, Constipation, Cecal intubation time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that admit for colonoscopy to Sisli Hamidiye Etfal Research and Training Hospital
Key inclusion criteria (1 listed)
- 18-95 years old, admitted for colonoscopy
Key exclusion criteria (1 listed)
- Colonic resection history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cecal intubation rate
Time frame: During the colonoscopy
The rate of reaching the cecum in all colonoscopies performed
Ileal intubation rate
Time frame: During the colonoscopy
The rate of reaching the terminal ileum in all colonoscopies performed
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
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
1 secondary outcome
Adenoma detection rate
Time frame: During the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Dincer, MD principal investigator
Sisli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cecal intubation rate (time frame: During the colonoscopy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.