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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03854422
Other study ID # EasyCOLON study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2019
Est. completion date April 20, 2019

Study information

Verified date February 2019
Source Bulent Ecevit University
Contact BETÜL TOPAL, 1
Phone +905446555091
Email betultopal90@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 20, 2019
Est. primary completion date March 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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, constipation

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 Design


Intervention

Device:
left position
colonoscopy will be performed in 3 different locations. Left position, the patient will be in the left-side position during the entire colonoscopy
left supine position
Colonoscopy in the Left supine position
dynamic position
Colonoscopy in the Dynamic position

Locations

Country Name City State
Turkey Betul Topal Zonguldak Kozlu Bulent Ecevit University Faculty OF Medicine

Sponsors (1)

Lead Sponsor Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to reach cecum Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum 2 hour
Secondary patient's comfort assessment: Visual Analog Score 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
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