- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854422
For Easy, Fast and Comfortable Colonoscopy, Which Position (EFC_COLON)
February 23, 2019 updated by: BETÜL TOPAL, Bulent Ecevit University
Which Position is Suitable for Easy, Fast and Comfortable Colonoscopy
Colonoscopy is one of the most common endoscopic procedures today.
However, it sometimes can be a serious challenging situation both for the clinicians and patients.
In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
colonoscopy and colonoscopic screening are the most common routine studies to reduce the incidence of colorectal cancer.In this process, the most important problem for the endoscopist and the patient is pain, loop formation, (the reason why the device is not able to progress in the bowel) and in some patients it takes a long time due to these reasons and the risk of complication development.The subject of what should be the most ideal position in colonoscopy has previously been studied in some specific subgroups.There is not enough study on what should be the ideal position in colonoscopy.
In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BETÜL TOPAL, 1
- Phone Number: +905446555091
- Email: betultopal90@hotmail.com
Study Contact Backup
- Name: TARIK AKAR, 2
- Phone Number: +905054192900
- Email: drtarikakar@gmail.com
Study Locations
-
-
Kozlu Bulent Ecevit University Faculty OF Medicine
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Zonguldak, Kozlu Bulent Ecevit University Faculty OF Medicine, Turkey, 67600
- Recruiting
- Betul Topal
-
Contact:
- BETÜL TOPAL, 1
- Phone Number: +905446555091
- Email: betultopal90@hotmail.com
-
Contact:
- TARIK AKAR, 2
- Phone Number: +905054192900
- Email: drtarikakar@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients aged for 18 to 80 years,
- colonoscopy indications (iron deficiency anemia ,Malignancy screening in patients over 50 years of age,secret blood positivity in stool, rectal bleeding,patients describing Hematoconia, chronic diarrhea, constıpatıon
Exclusion Criteria:
- patients with previous colon surgery
- serious comorbid disease (congestive heart failure ef< %30 , advanced chronic obstructive pulmonary disease,terminal period cancer with a life expectancy of less than 5 years, those who have not had appropriate bowel cleaning,endoscopic treatment during colonoscopy or removal of diagnostic lesions,other sedatives for sedation other than midazolam
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Left Position during colonoscopy
Left position, the patient will be in the left-side position during the entire colonoscopy period.
If necessary, change of position and pressure will be allowed.
During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured.Moreover, process recall, sedation amounts and pain scale will be measured after the procedure..During the process, it will be examined whether there is any need for loop formation, repositioning requirement and pressure requirements.
The type and amount of anesthetic agent (midazolam) used during the process is paid attention to be equal.
All procedures will be done with the same brand device.
After the procedure, a mini questionnaire will be applied to the patients for the pain scale.
|
colonoscopy will be performed in 3 different locations.
Left position, the patient will be in the left-side position during the entire colonoscopy
Other Names:
|
ACTIVE_COMPARATOR: Left Supine Position during colonoscopy
Left Supine position, the patient will be in the left and supine ( after splenic flexura) position during the entire colonoscopy period.
If necessary, change of position and pressure will be allowed.
During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured.
|
Colonoscopy in the Left supine position
|
ACTIVE_COMPARATOR: Dynamic position during colonoscopy
Dynamic position, the patient will be stared as left position during colonoscopy period.
If necessary, change of position and pressure will be allowed at any time.
During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured..During the process, it will be examined whether there is any need for loop formation, repositioning requirement and pressure requirements.
The type and amount of anesthetic agent used during the process is paid attention to be equal.
The use of midazolam as an anesthetic agent was planned.All procedures will be done with the same brand device.
After the procedure, a mini questionnaire will be applied to the patients for the pain scale.
|
Colonoscopy in the Dynamic position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to reach cecum
Time Frame: 2 hour
|
Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum
|
2 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient's comfort assessment: Visual Analog Score
Time Frame: 3 hour
|
patients' discomfort will be assessed by a 10-cm visual analog scale, in which a score of 0 denoted no pain and a score of 10 denoted unbearable pain
|
3 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: TARIK AKAR, MD, BULENT ECEVIT UNIVERSITY FACULTY OF MEDICINE , GASTROENTEROLOGY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 18, 2019
Primary Completion (ANTICIPATED)
March 20, 2019
Study Completion (ANTICIPATED)
April 20, 2019
Study Registration Dates
First Submitted
January 11, 2019
First Submitted That Met QC Criteria
February 23, 2019
First Posted (ACTUAL)
February 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 26, 2019
Last Update Submitted That Met QC Criteria
February 23, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EasyCOLON study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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