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
- 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
Detailed Summary:
Sponsor: Changhai Hospital
Current Primary Outcome: Mean Intubation Time (MIT) [ Time Frame: At the end of the procedure, up to 1 hour ]
Original Primary Outcome: Mean Intubation Time (MIT) [ Time Frame: At the end of the study, up to 1 year ]
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