Colon Polyps Clinical Trial
Official title:
Impact of 9-minute Withdrawal Time on Adenoma Detection Rate:a Multicenter, Prospective, Randomized Controlled Trial
Verified date | December 2019 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital, Second Military Medical University | Shanghai |
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 |
China,
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 |
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