EndoscopyNCT03002662
Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial
An observational study of Endoscopy and Colonoscopy, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy, Colonoscopy
- What is being tested?
- colonoscopy
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to 15 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are cases of distant referral to the gastroenterology surgeon's polyclinic and indications for colonoscopy.
Who may be able to join
- 1. Above 18
Who cannot join
- Bad bowel preparation
- Failure of cecum intubation
- Inflammatory bowel disease
- Colectomy story
Trial locations and contacts
1 site in 1 country.
Mustafa Duman contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eagle Run High Special Education and Research Hospital
Istanbul
Ebubekir Gündeş, ebubekir82@hotmail.com
About this study
During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define.
- Conditions
- Endoscopy, Colonoscopy
- Being tested
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyOther
| Study group | Role | What they receive |
|---|---|---|
| BMI <18.5 underweight (Group 1) | BMI was calculated as weight in kilograms divided by the square of height in meters. BMI <18.5 underweight (Group 1) Receives: Other: colonoscopy | |
| BMİ: 18.5 - 24.9 normal weight (Group 2) | BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 18.5 - 24.9 normal weight (Group 2) Receives: Other: colonoscopy | |
| BMİ: 25- 29.9 overweight (Group 3) | BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 25- 29.9 overweight (Group 3) Receives: Other: colonoscopy | |
| BMİ>30 obese (Group 4) | BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ>30 obese (Group 4) Receives: Other: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (kg/m2)
Measured: 12/01/2016- 05/01/2017
waist circumference (centimeter)
Measured: 12/01/2016- 05/01/2017
waist / hip ratio
Measured: 12/01/2016- 05/01/2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion1 Sep 2017 (estimated)
- Study completion15 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ebubekir Gündeş, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002662
- Sponsor's protocol ID
- 2016.5/8-19
- Status last verified
- May 2017
- First submitted
- 18 Dec 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03002662
- Acronym / sponsor ID
- 2016.5/8-19
- Conditions
- Endoscopy, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Dec 2016
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 15 Sep 2017 (estimated)
- First posted
- 26 Dec 2016 (estimated)
- 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.
During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMI <18.5 underweight (Group 1) | – | Other: colonoscopyBMI was calculated as weight in kilograms divided by the square of height in meters. BMI <18.5 underweight (Group 1) |
| BMİ: 18.5 - 24.9 normal weight (Group 2) | – | Other: colonoscopyBMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 18.5 - 24.9 normal weight (Group 2) |
| BMİ: 25- 29.9 overweight (Group 3) | – | Other: colonoscopyBMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 25- 29.9 overweight (Group 3) |
| BMİ>30 obese (Group 4) | – | Other: colonoscopyBMI was calculated as weight in kilograms divided by the square of height in meters. BMİ>30 obese (Group 4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are cases of distant referral to the gastroenterology surgeon's polyclinic and indications for colonoscopy.
Key inclusion criteria (1 listed)
- 1. Above 18
Key exclusion criteria (4 listed)
- Bad bowel preparation
- Failure of cecum intubation
- Inflammatory bowel disease
- Colectomy story
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy | Other | BMI <18.5 underweight (Group 1), BMİ: 18.5 - 24.9 normal weight (Group 2), BMİ: 25- 29.9 overweight (Group 3), BMİ>30 obese (Group 4) |
Primary outcome
Body mass index (kg/m2)
Time frame: 12/01/2016- 05/01/2017
waist circumference (centimeter)
Time frame: 12/01/2016- 05/01/2017
waist / hip ratio
Time frame: 12/01/2016- 05/01/2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
Mustafa Duman contact
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 Endoscopy and Colonoscopy, run by Kartal Kosuyolu Yuksek Ihtisas Education 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 4 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: status not confirmed, as of the sponsor's last update on 29 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Duman (drmustafaduman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (kg/m2) (time frame: 12/01/2016- 05/01/2017). The study lists 3 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 29 Aug 2017.