For Easy, Fast and Comfortable Colonoscopy, Which Position

NCT ID: NCT03854422

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2019-04-20

Brief Summary

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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

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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.

Conditions

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Colonic Diseases, Functional Prone Position Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

this study includes 3 different groups. left, left supine,dynamıc
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

left position

Intervention Type DEVICE

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 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.

Group Type ACTIVE_COMPARATOR

left supine position

Intervention Type DEVICE

Colonoscopy in the Left supine position

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.

Group Type ACTIVE_COMPARATOR

dynamic position

Intervention Type DEVICE

Colonoscopy in the Dynamic position

Interventions

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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

Intervention Type DEVICE

left supine position

Colonoscopy in the Left supine position

Intervention Type DEVICE

dynamic position

Colonoscopy in the Dynamic position

Intervention Type DEVICE

Other Intervention Names

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Colonoscopy in the Left position

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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BETÜL TOPAL

research assistant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TARIK AKAR, MD

Role: STUDY_DIRECTOR

BULENT ECEVIT UNIVERSITY FACULTY OF MEDICINE , GASTROENTEROLOGY

Locations

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Betul Topal

Zonguldak, Kozlu Bulent Ecevit University Faculty of Medicine, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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BETÜL TOPAL, 1

Role: CONTACT

+905446555091

TARIK AKAR, 2

Role: CONTACT

+905054192900

Facility Contacts

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BETÜL TOPAL, 1

Role: primary

+905446555091

TARIK AKAR, 2

Role: backup

+905054192900

Other Identifiers

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EasyCOLON study

Identifier Type: -

Identifier Source: org_study_id

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