9 Minutes for Colonoscopy Withdrawal

Naval Military Medical University

Status: Completed

Conditions: Colon Polyps; Colorectal Adenomas

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03399045

withdrawal time-1

Details and patient eligibility

About

A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.

Enrollment: 1,027 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients whose age is between 40-85.
• Patients who have indications for screening, surveillance and diagnostic colonoscopy.
• Patients who have signed inform consent form

Exclusion criteria

• Patients who have undergone colonic resection
• Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
• Patients with severe chronic cardiopulmonary and renal disease.
• Patients who are unwilling or unable to consent.
• Patients who are not suitable for colonoscopy
• Patients who received urgent or therapeutic colonoscopy
• Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
• Patients who are taking aspirin, clopidogrel or other anticoagulants
• Patients with Aronchick score > 3

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,027 participants in 2 patient groups

9-minute withdrawal group

Experimental group

Description:

Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included in the 9 minutes.

Treatment:

Procedure: 9-minute withdrawal

6-minute withdrawal group

Active Comparator group

Description:

Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy willwill not be included in the 9 minutes.

Treatment:

Procedure: 6-minute withdrawal