9 Minutes for Colonoscopy Withdrawal

Colon Polyps Clinical Trial

Official title:

Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399045
• Other study ID #: withdrawal time-1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: July 6, 2019

Study information

• Verified date: December 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1027
• Est. completion date: July 6, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Polyps
• Colorectal Adenomas

Intervention

Procedure:
• 9-minute withdrawal
Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw
• 6-minute withdrawal
Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (14)

Lead Sponsor

Collaborator

Changhai Hospital

Changzhi People's Hospital, First Affiliated Hospital of Harbin Medical University, Ningbo Medical Center Li Huili Eastern Hospital, No.85 Hospital, Changning, Shanghai, China, Qinghai Provincial People's Hospital, Shaanxi Provincial People's Hospital, Shanghai 8th People's Hospital, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of the Medical College, Shihezi University, The Second Clinical Medical College of Jinan University, The Seventh Medical Center of the PLA General Hospital, The Third People's Hospital of Datong, Yantaishan Hospital of Yantai City

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma detection rate(ADR)	ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.	30mins
Secondary	adenomas per colonoscopy(APC)	APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.	30mins