Colorectal Adenoma, Colorectal Polyp
Conditions
Keywords
Colonoscopy, Lower Gastrointestinal Tract, Magnetic Endoscopic Imaging, Abdominal Compression
Brief summary
The primary aim of this study is \- to explore the usefulness of abdominal compression on intubation. Other aims include 1. to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure 2. to get the knowledge of the formation of colon loops and its frequency 3. to clarify the impact of intubation with loops on adenoma detection rate
Interventions
BEHAVIORALAbdominal Compression
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.
DEVICEGuidance of Magnetic Endoscopic Imaging (MEI) System
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.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intubation Time (MIT) | At the end of the procedure, up to 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cecal Intubation Rate (CIR) | At the end of the procedure, up to 1 hour | 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. |
| Pain Score (PS) | During the procedure, up to 1 hour | 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. |
| Severe Adverse Event Rate (SAER) | The day of the procedure, 24 hours | 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. |
| Adenoma Detection Rate (ADR) | At the end of the procedure, up to 1 hour | ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. |
| Polyp Detection Rate (PDR) | At the end of the procedure, up to 1 hour | PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp. |
Countries
China
Contacts
Primary ContactEn-Da Yu, M.D.
Outcome results
None listed