Intubation Techniques on Colonoscopy Quality (SINOCOLO2013) (SINOCOLO2013)

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

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 Overview

• Status: Unknown
• Conditions: Colorectal Adenoma; Colorectal Polyp
• Intervention / Treatment: Behavioral: Abdominal Compression; Device: Guidance of Magnetic Endoscopic Imaging (MEI) System

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: En-Da Yu, M.D.; Phone Number: 08615921509177
      • Principal Investigator: En-Da Yu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: MEI System (Olympas, Tokyo, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the procedure, up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	At the end of the procedure, up to 1 hour

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: En-Da Yu, M.D., Changhai hospital, Shanghai, China

Publications and helpful links

General Publications

• Shah SG, Saunders BP, Brooker JC, Williams CB. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers. Gastrointest Endosc. 2000 Jul;52(1):1-8. doi: 10.1067/mge.2000.107296.
• Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
• Cheung HY, Chung CC, Kwok SY, Tsang WW, Li MK. Improvement in colonoscopy performance with adjunctive magnetic endoscope imaging: a randomized controlled trial. Endoscopy. 2006 Mar;38(3):214-7. doi: 10.1055/s-2005-921172.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Colonoscopy; Lower Gastrointestinal Tract; Magnetic Endoscopic Imaging; Abdominal Compression
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: SINOCOLO2013