9 Minutes for Tandem Colonoscopy Withdrawal

Not Applicable

Completed

• Conditions: Colon Polyp; Colorectal Adenoma
• Interventions: Procedure: 6-minute then 9-minute withdrawal; Procedure: 9-minute then 6-minute withdrawal

• Registration Number: NCT04797065
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Primary Completion: 2021-11-05
• Study Completion: 2021-12-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-29
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 733

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
6-minute then 9-minute withdrawal	6-minute then 9-minute withdrawal	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.
9-minute then 6-minute withdrawal	9-minute then 6-minute withdrawal	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.

Primary Outcome Measures

Name	Time	Method
adenoma miss rate(AMR)	60 minutes	Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.

Secondary Outcome Measures

Name	Time	Method
adenoma detection rate(ADR)	60 minutes	ADR is the number of patients with at least one adenoma, divided by the total number of patients.
advanced adenoma miss rate(AAMR)	60 minutes	AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.
adenomas per colonoscopy(APC)	60 minutes	APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.
patient-level AMR(pAMR)	60 minutes	the number of participants with adenomas detected only during the second-pass colonoscopy divided by the total number of participants with adenomas detected during the tandem colonoscopy

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China