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Intubation Techniques on Colonoscopy Quality (SINOCOLO2013) (SINOCOLO2013)

Primary Purpose

Colorectal Adenoma, Colorectal Polyp

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Abdominal Compression
Guidance of Magnetic Endoscopic Imaging (MEI) System
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Adenoma focused on measuring Colonoscopy, Lower Gastrointestinal Tract, Magnetic Endoscopic Imaging, Abdominal Compression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Experimental Group 2 (Monitoring)

Experimental Group 1 (Guiding)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Adenoma Detection Rate (ADR)
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Polyp Detection Rate (PDR)
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.

Full Information

First Posted
August 6, 2013
Last Updated
March 2, 2015
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01919463
Brief Title
Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)
Acronym
SINOCOLO2013
Official Title
Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma, Colorectal Polyp
Keywords
Colonoscopy, Lower Gastrointestinal Tract, Magnetic Endoscopic Imaging, Abdominal Compression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental Group 2 (Monitoring)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Group 1 (Guiding)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Abdominal Compression
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Guidance of Magnetic Endoscopic Imaging (MEI) System
Other Intervention Name(s)
MEI System (Olympas, Tokyo, Japan)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Intubation Time (MIT)
Description
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.
Time Frame
At the end of the procedure, up to 1 hour
Secondary Outcome Measure Information:
Title
Cecal Intubation Rate (CIR)
Description
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.
Time Frame
At the end of the procedure, up to 1 hour
Title
Pain Score (PS)
Description
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.
Time Frame
During the procedure, up to 1 hour
Title
Severe Adverse Event Rate (SAER)
Description
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.
Time Frame
The day of the procedure, 24 hours
Title
Adenoma Detection Rate (ADR)
Description
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Time Frame
At the end of the procedure, up to 1 hour
Title
Polyp Detection Rate (PDR)
Description
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
Time Frame
At the end of the procedure, up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
En-Da Yu, M.D.
Phone
08615921509177
Email
endayu@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Da Yu, M.D.
Organizational Affiliation
Changhai Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
En-Da Yu, M.D.
Phone
08615921509177
First Name & Middle Initial & Last Name & Degree
En-Da Yu, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
10882954
Citation
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.
Results Reference
background
PubMed Identifier
21481862
Citation
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.
Results Reference
background
PubMed Identifier
16528645
Citation
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.
Results Reference
background

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Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

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