For Easy, Fast and Comfortable Colonoscopy, Which Position

NCT03854422 | Unknown DMC

• 1 other identifier: EasyCOLON study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases, Functional; Prone Position; Endoscopy

Keywords

Colonoscopy; Insertıon tecnique; Prone; Left Supine; Dynamic

Outcome Measures

Primary Outcomes (1)

• Time to reach cecum

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

  2 hour

Secondary Outcomes (1)

• patient's comfort assessment: Visual Analog Score

  3 hour

Study Arms (3)

Left Position during colonoscopy

ACTIVE COMPARATOR

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

Left Supine Position during colonoscopy

ACTIVE COMPARATOR

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

Dynamic position during colonoscopy

ACTIVE COMPARATOR

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

Interventions

left position DEVICE

colonoscopy will be performed in 3 different locations. Left position, the patient will be in the left-side position during the entire colonoscopy

Also known as: Colonoscopy in the Left position

Left Position during colonoscopy

left supine position DEVICE

Colonoscopy in the Left supine position

Left Supine Position during colonoscopy

dynamic position DEVICE

Colonoscopy in the Dynamic position

Dynamic position during colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Betul Topal

Zonguldak, Kozlu Bulent Ecevit University Faculty of Medicine, 67600, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colonic Diseases, Functional

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• TARIK AKAR, MD

  BULENT ECEVIT UNIVERSITY FACULTY OF MEDICINE , GASTROENTEROLOGY

  STUDY DIRECTOR

Central Study Contacts

BETÜL TOPAL, 1

CONTACT

+905446555091; betultopal90@hotmail.com

TARIK AKAR, 2

CONTACT

+905054192900; drtarikakar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant doctor

Model Details: this study includes 3 different groups. left, left supine,dynamıc

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 26, 2019
• Study Start: January 18, 2019
• Primary Completion: March 20, 2019
• Study Completion: April 20, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

TU (1)