9 Minutes for Tandem Colonoscopy Withdrawal

Naval Military Medical University

Status: Completed

Conditions: Colorectal Adenoma; Colon Polyp

Treatments: Procedure: 9-minute then 6-minute withdrawal; Procedure: 6-minute then 9-minute withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT04797065

withdrawal time-2

Details and patient eligibility

About

A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.

Enrollment: 733 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients whose age is between 40-75.
• Patients who have indications for screening
• Patients who have signed inform consent form.

Exclusion criteria

• Patients who have undergone colonic resection or polypectomy
• Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
• Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days
• Patients with inflammatory bowel diseases
• Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
• Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
• Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
• Patients with failed cecal intubation
• Patients with poor BPQ that necessitated a second bowel preparation
• Patients with therapeutic colonoscopy for existing lesions
• Patients refusing to participate or to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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733 participants in 2 patient groups

6-minute then 9-minute withdrawal

Experimental group

Description:

Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the segmental withdrawal. At 6-minute withdrawal, the left colon, transverse colon and right colon will take 2 minutes each. Then at 9-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 3 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.

Treatment:

Procedure: 6-minute then 9-minute withdrawal

9-minute then 6-minute withdrawal

Active Comparator group

Description:

Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the segmental withdrawal. At 9-minute withdrawal, the left colon, transverse colon and right colon will take 3 minutes each. Then at 6-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 2 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.

Treatment:

Procedure: 9-minute then 6-minute withdrawal