Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

Naval Military Medical University

Status: Unknown

Conditions: Colorectal Adenoma; Colorectal Polyp

Treatments: Behavioral: Abdominal Compression; Device: Guidance of Magnetic Endoscopic Imaging (MEI) System

Study type: Interventional

Funder types: Other

Identifiers

NCT01919463

SINOCOLO2013

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Control Group

No Intervention group

Description:

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 Group 2 (Monitoring)

Experimental group

Description:

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.

Treatment:

Behavioral: Abdominal Compression

Experimental Group 1 (Guiding)

Experimental group

Description:

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.

Treatment:

Device: Guidance of Magnetic Endoscopic Imaging (MEI) System

Behavioral: Abdominal Compression