Examining Techniques on Adenoma Miss Rate in Proximal Colon (SINOCOLO2017)

Naval Military Medical University

Status: Unknown

Conditions: Colorectal Adenoma; Colorectal Polyp

Treatments: Procedure: Retroflexion; Procedure: Re-examination

Study type: Interventional

Funder types: Other

Identifiers

NCT03355443

SINOCOLO2017

2017YFC1308802 (Other Grant/Funding Number)

Details and patient eligibility

About

The primary aim of this study is

• to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.

Other aims include to explore the data below when re-examination or retroflexion is used.

• Adenoma detection rate, ADR
• Polyp miss rate, PMR
• Polyp detection rate, PDR
• Withdrawal time, WT

Full description

AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)

Enrollment: 600 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result

Exclusion criteria

• Pregnant female patients
• Patients received colonoscopy in the past 5 years
• 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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600 participants in 2 patient groups

Re-examination Group

Active Comparator group

Description:

Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method.

Treatment:

Procedure: Re-examination

Retroflexion Group

Experimental group

Description:

Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method.

Treatment:

Procedure: Retroflexion