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The primary aim of this study is
- to explore the usefulness of abdominal compression on intubation.
Other aims include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | 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 Group 2 (Monitoring) | Experimental | 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. |
|
| Experimental Group 1 (Guiding) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Compression | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| En-Da Yu, M.D. | Contact | 08615921509177 | endayu@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| En-Da Yu, M.D. | Changhai Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10882954 | Background | Shah SG, Saunders BP, Brooker JC, Williams CB. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers. Gastrointest Endosc. 2000 Jul;52(1):1-8. doi: 10.1067/mge.2000.107296. | |
| 21481862 | Background | Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8. |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Guidance of Magnetic Endoscopic Imaging (MEI) System | Device | 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. |
|
|
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 |
| 16528645 | Background | Cheung HY, Chung CC, Kwok SY, Tsang WW, Li MK. Improvement in colonoscopy performance with adjunctive magnetic endoscope imaging: a randomized controlled trial. Endoscopy. 2006 Mar;38(3):214-7. doi: 10.1055/s-2005-921172. |