Clinical trial NCT04797065: 9 Minutes for Tandem Colonoscopy Withdrawal
Official title: Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Colorectal Adenoma
Keywords: withdrawal time
adenoma miss rate
tandem colonoscopy
adenoma detection rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: No.85 Hospital, Changning, Shanghai, China
name: Yantaishan Hospital of Yantai City, Yantai, China
name: Seventh Medical Center of PLA Army General Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: The First Affiliated Hospital of the Medical College, Shihezi University
name: Shanghai 8th People's Hospital
name: Shanxi Provincial People's Hospital
name: Qinghai People's Hospital
name: Leqing People's Hospital
name: Afﬁliated Hospital of North Sichuan Medical College
name: Zhejiang University
name: Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
name: The General Hospital of Eastern Theater Command
name: Heilongjiang provincial hospital
name: The Second Hospital of Hebei Medical University
First posted: 2021-03-15
Enrollment: 733
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: adenoma miss rate(AMR)
timeFrame: 60 minutes
Secondary outcomes:
measure: advanced adenoma miss rate(AAMR)
timeFrame: 60 minutes
measure: adenoma detection rate(ADR)
timeFrame: 60 minutes
measure: adenomas per colonoscopy(APC)
timeFrame: 60 minutes
measure: patient-level AMR(pAMR)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, 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.
citation: Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.