Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)
NCT ID: NCT01919463
Last Updated: 2015-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2015-03-31
2016-02-29
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Group
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.
No interventions assigned to this group
Experimental Group 2 (Monitoring)
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.
Abdominal 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.
Experimental Group 1 (Guiding)
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.
Abdominal 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.
Guidance 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.
Interventions
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Abdominal 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.
Guidance 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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En-Da Yu
Surgical Professor, Vice Director of Department of Colorectal Surgery and Center of GI Endoscopy
Principal Investigators
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En-Da Yu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital, Shanghai, China
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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En-Da Yu, M.D.
Role: primary
References
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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.
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.
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.
Other Identifiers
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SINOCOLO2013
Identifier Type: -
Identifier Source: org_study_id
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