Colon Polyps, Colorectal Adenomas
Conditions
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.
Interventions
PROCEDURE9-minute withdrawal
Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw
PROCEDURE6-minute withdrawal
Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw
Sponsors
No.85 Hospital, Changning, Shanghai, China
The Second Clinical Medical College of Jinan University
Qinghai People's Hospital
Shaanxi Provincial People's Hospital
Shanghai 8th People's Hospital
Yantaishan Hospital of Yantai City
First Affiliated Hospital of Harbin Medical University
Changzhi People's Hospital
Ningbo Medical Center Li Huili Eastern Hospital
The Third People's Hospital of Datong
The First Affiliated Hospital of the Medical College, Shihezi University
The First Affiliated Hospital of Dalian Medical University
Seventh Medical Center of PLA Army General Hospital
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate(ADR) | 30mins | ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adenomas per colonoscopy(APC) | 30mins | APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies. |
Countries
China
Outcome results
None listed