Clinical trial NCT03399045: 9 Minutes for Colonoscopy Withdrawal
Official title: Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyps
Colorectal Adenomas
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: No.85 Hospital, Changning, Shanghai, China
name: The Second Clinical Medical College of Jinan University
name: Qinghai People's Hospital
name: Shaanxi Provincial People's Hospital
name: Shanghai 8th People's Hospital
name: Yantaishan Hospital of Yantai City
name: First Affiliated Hospital of Harbin Medical University
name: Changzhi People's Hospital
name: Ningbo Medical Center Li Huili Eastern Hospital
name: The Third People's Hospital of Datong
name: The First Affiliated Hospital of the Medical College, Shihezi University
name: The First Affiliated Hospital of Dalian Medical University
name: Seventh Medical Center of PLA Army General Hospital
First posted: 2018-01-16
Enrollment: 1027
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: adenoma detection rate(ADR)
timeFrame: 30mins
Secondary outcomes:
measure: adenomas per colonoscopy(APC)
timeFrame: 30mins
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Li Zhaoshen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao S, Yang X, Wang S, Meng Q, Wang R, Bo L, Chang X, Pan P, Xia T, Yang F, Yao J, Zheng J, Sheng J, Zhao X, Tang S, Wang Y, Wang Y, Gong A, Chen W, Shen J, Zhu X, Wang S, Yan C, Yang Y, Zhu Y, Ma RJ, Wang R, Ma Y, Li Z, Bai Y. Impact of 9-Minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e168-e181. doi: 10.1016/j.cgh.2020.11.019. Epub 2020 Nov 19.