Colon Polyp, Colorectal Adenoma
Conditions
Keywords
withdrawal time, adenoma miss rate, tandem colonoscopy, adenoma detection rate
Brief summary
A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.
Interventions
PROCEDURE6-minute then 9-minute withdrawal
Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 2 minutes then in 3 minutes during each colonic segment. In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes.
PROCEDURE9-minute then 6-minute withdrawal
Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 3 minutes then in 2 minutes during each colonic segment. In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes.
Sponsors
No.85 Hospital, Changning, Shanghai, China
Yantaishan Hospital of Yantai City, Yantai, China
Seventh Medical Center of PLA Army General Hospital
The First Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of the Medical College, Shihezi University
Shanghai 8th People's Hospital
Shanxi Provincial People's Hospital
Qinghai People's Hospital
Leqing People's Hospital
Affiliated Hospital of North Sichuan Medical College
Zhejiang University
Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
The General Hospital of Eastern Theater Command
Heilongjiang provincial hospital
The Second Hospital of Hebei Medical University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose age is between 40-75. * Patients who have indications for screening * Patients who have signed inform consent form.
Exclusion criteria
* Patients who have undergone colonic resection or polypectomy * Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination * Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days * Patients with inflammatory bowel diseases * Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests * Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis). * Patients with pregnancy, severe chronic cardiopulmonary and renal disease. * Patients with failed cecal intubation * Patients with poor BPQ that necessitated a second bowel preparation * Patients with therapeutic colonoscopy for existing lesions * Patients refusing to participate or to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma miss rate(AMR) | 60 minutes | Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| advanced adenoma miss rate(AAMR) | 60 minutes | AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass. |
| adenoma detection rate(ADR) | 60 minutes | ADR is the number of patients with at least one adenoma, divided by the total number of patients. |
| adenomas per colonoscopy(APC) | 60 minutes | APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies. |
| patient-level AMR(pAMR) | 60 minutes | the number of participants with adenomas detected only during the second-pass colonoscopy divided by the total number of participants with adenomas detected during the tandem colonoscopy |
Countries
China
Outcome results
None listed