Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)
SINOCOLO2013
1 other identifier
interventional
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 3, 2015
March 1, 2015
5 months
August 6, 2013
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Cecal Intubation Rate (CIR)
At the end of the procedure, up to 1 hour
Pain Score (PS)
During the procedure, up to 1 hour
Severe Adverse Event Rate (SAER)
The day of the procedure, 24 hours
Adenoma Detection Rate (ADR)
At the end of the procedure, up to 1 hour
Polyp Detection Rate (PDR)
At the end of the procedure, up to 1 hour
Study Arms (3)
Control Group
NO INTERVENTIONColonoscopy 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)
EXPERIMENTALColonoscopy 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)
EXPERIMENTALColonoscopy 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (3)
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.
PMID: 10882954BACKGROUNDHolme 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.
PMID: 21481862BACKGROUNDCheung 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.
PMID: 16528645BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
En-Da Yu, M.D.
Changhai Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgical Professor, Vice Director of Department of Colorectal Surgery and Center of GI Endoscopy
Study Record Dates
First Submitted
August 6, 2013
First Posted
August 9, 2013
Study Start
March 1, 2015
Primary Completion
August 1, 2015
Study Completion
February 1, 2016
Last Updated
March 3, 2015
Record last verified: 2015-03