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For Easy, Fast and Comfortable Colonoscopy, Which Position (EFC_COLON)

Primary Purpose

Colonic Diseases, Functional, Prone Position, Endoscopy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
left position
left supine position
dynamic position
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colonic Diseases, Functional focused on measuring Colonoscopy, Insertıon tecnique, Prone, Left Supine, Dynamic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Betul TopalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Left Position during colonoscopy

Left Supine Position during colonoscopy

Dynamic position during colonoscopy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Time to reach cecum
Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2019
Last Updated
February 23, 2019
Sponsor
Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT03854422
Brief Title
For Easy, Fast and Comfortable Colonoscopy, Which Position
Acronym
EFC_COLON
Official Title
Which Position is Suitable for Easy, Fast and Comfortable Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
March 20, 2019 (Anticipated)
Study Completion Date
April 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Functional, Prone Position, Endoscopy
Keywords
Colonoscopy, Insertıon tecnique, Prone, Left Supine, Dynamic

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
this study includes 3 different groups. left, left supine,dynamıc
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left Position during colonoscopy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Left Supine Position during colonoscopy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dynamic position during colonoscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
left position
Other Intervention Name(s)
Colonoscopy in the Left position
Intervention Description
colonoscopy will be performed in 3 different locations. Left position, the patient will be in the left-side position during the entire colonoscopy
Intervention Type
Device
Intervention Name(s)
left supine position
Intervention Description
Colonoscopy in the Left supine position
Intervention Type
Device
Intervention Name(s)
dynamic position
Intervention Description
Colonoscopy in the Dynamic position
Primary Outcome Measure Information:
Title
Time to reach cecum
Description
Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum
Time Frame
2 hour
Secondary Outcome Measure Information:
Title
patient's comfort assessment: Visual Analog Score
Description
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
Time Frame
3 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BETÜL TOPAL, 1
Phone
+905446555091
Email
betultopal90@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
TARIK AKAR, 2
Phone
+905054192900
Email
drtarikakar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TARIK AKAR, MD
Organizational Affiliation
BULENT ECEVIT UNIVERSITY FACULTY OF MEDICINE , GASTROENTEROLOGY
Official's Role
Study Director
Facility Information:
Facility Name
Betul Topal
City
Zonguldak
State/Province
Kozlu Bulent Ecevit University Faculty OF Medicine
ZIP/Postal Code
67600
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BETÜL TOPAL, 1
Phone
+905446555091
Email
betultopal90@hotmail.com
First Name & Middle Initial & Last Name & Degree
TARIK AKAR, 2
Phone
+905054192900
Email
drtarikakar@gmail.com

12. IPD Sharing Statement

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