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 Locations

  • Turkey
    • Kozlu Bulent Ecevit University Faculty OF Medicine
      • Zonguldak, Kozlu Bulent Ecevit University Faculty OF Medicine, Turkey, 67600

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.
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
Other Names:
  • Colonoscopy in the Left position
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.
Device: left supine position
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.
Device: dynamic position
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

Bulent Ecevit University

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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