Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Changhai Hospital
Sponsor:
Information provided by (Responsible Party):
En-Da Yu, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01919463
First received: August 6, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention
Colorectal Adenoma
Colorectal Polyp
Behavioral: Abdominal Compression
Device: Guidance of Magnetic Endoscopic Imaging (MEI) System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • Mean Intubation Time (MIT) [ Time Frame: At the end of the procedure, up to 1 hour ] [ Designated as safety issue: No ]
    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) [ Time Frame: At the end of the procedure, up to 1 hour ] [ Designated as safety issue: No ]
    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) [ Time Frame: During the procedure, up to 1 hour ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: The day of the procedure, 24 hours ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: At the end of the procedure, up to 1 hour ] [ Designated as safety issue: No ]
    ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.

  • Polyp Detection Rate (PDR) [ Time Frame: At the end of the procedure, up to 1 hour ] [ Designated as safety issue: No ]
    PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.


Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.
Behavioral: 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: 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.
Behavioral: 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.
Device: 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 Name: MEI System (Olympas, Tokyo, Japan)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919463

Contacts
Contact: En-Da Yu, M.D. 08615921509177 endayu@yeah.net

Locations
China, Shanghai
Changhai Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: En-Da Yu, M.D.    08615921509177      
Principal Investigator: En-Da Yu, M.D.         
Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: En-Da Yu, M.D. Changhai Hospital, Shanghai, China
  More Information

Publications:
Responsible Party: En-Da Yu, Surgical Professor, Vice Director of Department of Colorectal Surgery and Center of GI Endoscopy, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01919463     History of Changes
Other Study ID Numbers: SINOCOLO2013
Study First Received: August 6, 2013
Last Updated: February 27, 2014
Health Authority: China: Ministry of Health

Keywords provided by Changhai Hospital:
Colonoscopy
Lower Gastrointestinal Tract
Magnetic Endoscopic Imaging
Abdominal Compression

ClinicalTrials.gov processed this record on October 16, 2014