Clinical Trial: Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial

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

Detailed Summary:
Sponsor: Changhai Hospital

Current Primary Outcome: Mean Intubation Time (MIT) [ Time Frame: At the end of the procedure, up to 1 hour ]

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.


Original Primary Outcome: Mean Intubation Time (MIT) [ Time Frame: At the end of the study, up to 1 year ]

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.


Current Secondary Outcome:

  • Cecal Intubation Rate (CIR) [ Time Frame: At the end of the procedure, up to 1 hour ]
    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 ]
    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 ]
    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 ]
    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 ]
    PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.


Original Secondary Outcome:

  • Cecal Intubation Rate (CIR) [ Time Frame: At the end of the study, up to 1 year ]
    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 ]
    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 ]
    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 study, up to 1 year ]
    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 study, up to 1 year ]
    PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.


Information By: Changhai Hospital

Dates:
Date Received: August 6, 2013
Date Started: March 2015
Date Completion: February 2016
Last Updated: March 2, 2015
Last Verified: March 2015