Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

Colorectal Adenoma Clinical Trial

— SINOCOLO2013  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01919463
• Other study ID #: SINOCOLO2013
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2013
• Last updated: March 2, 2015
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2015
• Source: Changhai Hospital
• Contact: En-Da Yu, M.D.
• Phone: 08615921509177
• Email: endayu[@]yeah.net
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Adenoma
• Colorectal Polyp

Intervention

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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Holme Ö, Höie 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No