Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

N/AUnknownNCT01919463

Changhai Hospital300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Colorectal Adenoma Colorectal Polyp

Interventions

Abdominal CompressionBEHAVIORAL

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.

Guidance of Magnetic Endoscopic Imaging (MEI) SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: At the end of the procedure, up to 1 hour

Secondary Outcomes

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.

Time frame: At the end of the procedure, up to 1 hour

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.

Time frame: During the procedure, up to 1 hour

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.

Time frame: The day of the procedure, 24 hours

Adenoma Detection Rate (ADR)

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

Polyp Detection Rate (PDR)

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

Central Contacts

En-Da Yu, M.D.

CONTACT

08615921509177 endayu@yeah.net

Data from ClinicalTrials.gov

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