ColonoscopyNCT03128645
The Effect of the Abdominal Corset on Colonoscopy
An observational study of Colonoscopy and Complete Colonoscopy, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In patients with central obesity, the effect of the abdominal corset on colonoscopy completeness, cecum and ileum intubation time will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Complete Colonoscopy, Cecum Intubation Time
- What is being tested?
- Abdominal Corset
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 15 Dec 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: The patients who were remotely applying to our clinic and planned for colonoscopy according to ASGE colonoscopy indications.
Who may be able to join
- Above 18 years, Meeting the central obesity criteria Cases where colonoscopy is performed under elective conditions
Who cannot join
- In case of emergency, The process is terminated due to bad bowel preparation, Inflammatory bowel disease, Serious arrhythmia, Chronic obstructive pulmonary disease Coronary artery disease The previous abdominal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Kosuyolu Yuksek Ihtisas Education and Research
Istanbul, 34000
About this study
Official title: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
In patients with central obesity, the effect of the abdominal corset on colonoscopy completeness, cecum and ileum intubation time will be investigated.
- Being tested
- Abdominal Corset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal CorsetDevice
The patient's colonoscopy procedure in group 2 after randomization will be performed with the abdominal corset.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Standard method group Receives: Device: Abdominal Corset | |
| Group 2 | Abdominal corset group Receives: Device: Abdominal Corset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Obesity
BMI ≥ 30 (kg / m2), waist circumference> 102 cm in men and waist circumference> 88 cm in women
Measured: 01/04/2017- 01/06/2017
Cecum intubation time
Insertion time of the colonoscope from anus to the cecum (second)
Measured: 01/04/2017- 01/06/2017
İleum intubation time
Insertion time of the colonoscope from cecum to the ileum (second)
Measured: 01/04/2017- 01/06/2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Apr 2017
- Primary completion1 Sep 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
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
- NCT03128645
- Sponsor's protocol ID
- 2017/3/19
- Status last verified
- Jul 2024
- First submitted
- 17 Apr 2017
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gundes E, Ofkeli O, Uzun O, Senger AS, Polat E, Duman M. Effect of Abdominal Corset on Completion of Colonoscopy and Cecal and Ileocecal Intubation Time in Patients with Central Obesity: A Prospective Randomized Controlled Trial. Ann Ital Chir. 2024;95(4):603-608. doi: 10.62713/aic.3348.
PubMed 39186356
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- ClinicalTrials.gov ID
- NCT03128645
- Acronym / sponsor ID
- 2017/3/19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 25 Apr 2017 (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 patients with central obesity, the effect of the abdominal corset on colonoscopy completeness, cecum and ileum intubation time will be investigated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Abdominal CorsetStandard method group |
| Group 2 | – | Device: Abdominal CorsetAbdominal corset group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were remotely applying to our clinic and planned for colonoscopy according to ASGE colonoscopy indications.
Key inclusion criteria (1 listed)
- Above 18 years, Meeting the central obesity criteria Cases where colonoscopy is performed under elective conditions
Key exclusion criteria (1 listed)
- In case of emergency, The process is terminated due to bad bowel preparation, Inflammatory bowel disease, Serious arrhythmia, Chronic obstructive pulmonary disease Coronary artery disease The previous abdominal surgery
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 |
|---|---|---|
| Abdominal CorsetThe patient's colonoscopy procedure in group 2 after randomization will be performed with the abdominal corset. | Device | Group 1, Group 2 |
Primary outcome
Central Obesity
Time frame: 01/04/2017- 01/06/2017
BMI ≥ 30 (kg / m2), waist circumference> 102 cm in men and waist circumference> 88 cm in women
Cecum intubation time
Time frame: 01/04/2017- 01/06/2017
Insertion time of the colonoscope from anus to the cecum (second)
İleum intubation time
Time frame: 01/04/2017- 01/06/2017
Insertion time of the colonoscope from cecum to the ileum (second)
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 23 Jul 2024.
- Derived from this study: PubMed 39186356Gundes E, Ofkeli O, Uzun O, Senger AS, Polat E, Duman M. Effect of Abdominal Corset on Completion of Colonoscopy and Cecal and Ileocecal Intubation Time in Patients with Central Obesity: A Prospective Randomized Controlled Trial. Ann Ital Chir. 2024;95(4):603-608. doi: 10.62713/aic.3348.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Complete 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 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 23 Jul 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?
Central Obesity (time frame: 01/04/2017- 01/06/2017). 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?
On the ClinicalTrials.gov record for NCT03128645, which also lists 1 linked publication.
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 23 Jul 2024.