Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

Not Applicable

• Conditions: Colorectal Polyp; Colorectal Adenoma

• Registration Number: NCT01919463
• Lead Sponsor: Changhai Hospital

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-09
• Status Verified: 2015-03
• Study Start: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-03
• Primary Completion: 2015-08
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Intubation Time (MIT)	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.

Secondary Outcome Measures

Name	Time	Method
Polyp Detection Rate (PDR)	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.
Severe Adverse Event Rate (SAER)	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.
Cecal Intubation Rate (CIR)	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.
Adenoma Detection Rate (ADR)	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.
Pain Score (PS)	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.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China