For Easy, Fast and Comfortable Colonoscopy, Which Position

Not Applicable

• Conditions: Endoscopy; Colonic Diseases, Functional; Prone Position
• Interventions: Device: left position; Device: left supine position; Device: dynamic position

• Registration Number: NCT03854422
• Lead Sponsor: Bulent Ecevit University

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.

Study Timeline

• Study First Submitted: 2019-01-11
• Study Start: 2019-01-18
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-23
• Last Update Submitted: 2019-02-23
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-03-20
• Study Completion: 2019-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Position during colonoscopy	left position	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 during colonoscopy	left supine position	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 during colonoscopy	dynamic position	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.

Primary Outcome Measures

Name	Time	Method
Time to reach cecum	2 hour	Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum

Secondary Outcome Measures

Name	Time	Method
patient's comfort assessment: Visual Analog Score	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

Trial Locations

Locations (1)

Betul Topal; 🇹🇷 Zonguldak, Kozlu Bulent Ecevit University Faculty OF Medicine, Turkey