Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

Study Overview
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Brief Summary
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The primary aim of this study is - to explore the usefulness of abdominal compression on intubation. Other aims include to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure to get the knowledge of the formation of colon loops and its frequency to clarify the impact of intubation with loops on adenoma detection rate

Official Title
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Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial

Conditions
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Colorectal Adenoma, Colorectal Polyp

Intervention / Treatment
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* Behavioral: Abdominal Compression
* Device: Guidance of Magnetic Endoscopic Imaging (MEI) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment Exclusion Criteria: Pregnant female patients Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on Patients who had previous abdominal surgery Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema) Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding Patients who have inadequate bowel preparation Patients who reject to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Colonoscopy is completed without abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. | |
| Experimental: Experimental Group 2 (Monitoring)<br>Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression by his subjective judgement. | Behavioral: Abdominal Compression<br>* Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.<br>|
| Experimental: Experimental Group 1 (Guiding)<br>Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system. | Behavioral: Abdominal Compression<br>* Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.<br>Device: Guidance of Magnetic Endoscopic Imaging (MEI) System<br>* Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process.<br>* Other names: MEI System (Olympas, Tokyo, Japan);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intubation Time (MIT) | MIT refers to the mean of intubation time. Intubation time refers to the time spent on the intubation procedure. Intubation is defined as the procedure during which the tip of the colonoscope reaches the cecum from the anus. | At the end of the procedure, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal Intubation Rate (CIR) | CIR refers to the proportion of the subjects who receive the whole colon examination. The whole colon examination means the tip of the colonoscope reaches the cecum during the procedure. | At the end of the procedure, up to 1 hour | 
| Pain Score (PS) | PS is measure by the numerical rating scale during the intubation process. Numerical rating scale contains 11 ranks from 0 to 10, in which 0 means no pain and 10 means the extreme pain cannot be borne. | During the procedure, up to 1 hour | 
| Severe Adverse Event Rate (SAER) | SAER refers to the proportion of the subjects to whom severe adverse events happens. Severe adverse events include perforation, massive hemorrhage, lethal arrhythmia, death and so on. | The day of the procedure, 24 hours | 
| Adenoma Detection Rate (ADR) | ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. | At the end of the procedure, up to 1 hour | 
| Polyp Detection Rate (PDR) | PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp. | At the end of the procedure, up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Lower Gastrointestinal Tract, Magnetic Endoscopic Imaging, Abdominal Compression