9 Minutes for Colonoscopy Withdrawal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1027 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2019-07-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Colon Polyps Colorectal Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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9-minute withdrawal group

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.

Group Type EXPERIMENTAL

9-minute withdrawal

Intervention Type PROCEDURE

Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw

6-minute withdrawal group

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.

Group Type ACTIVE_COMPARATOR

6-minute withdrawal

Intervention Type PROCEDURE

Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw

Interventions

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9-minute withdrawal

Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw

Intervention Type PROCEDURE

6-minute withdrawal

Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No