9 Minutes for Tandem Colonoscopy Withdrawal

Colorectal Adenoma Clinical Trial

Official title:

Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797065
• Other study ID #: withdrawal time-2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 5, 2021

Study information

• Verified date: January 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 733
• Est. completion date: December 5, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Polyp
• Colorectal Adenoma

Intervention

Procedure:
• 6-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.
• 9-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.

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (16)

Lead Sponsor

Collaborator

Changhai Hospital

Af?liated Hospital of North Sichuan Medical College, Heilongjiang provincial hospital, Leqing People's Hospital, No.85 Hospital, Changning, Shanghai, China, Qinghai People's Hospital, Seventh Medical Center of PLA Army General Hospital, Shanghai 8th People's Hospital, Shanxi Provincial People's Hospital, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of the Medical College, Shihezi University, The General Hospital of Eastern Theater Command, The Second Hospital of Hebei Medical University, Yantaishan Hospital of Yantai City, Yantai, China, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma miss rate(AMR)	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.	60 minutes
Secondary	advanced adenoma miss rate(AAMR)	AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.	60 minutes
Secondary	adenoma detection rate(ADR)	ADR is the number of patients with at least one adenoma, divided by the total number of patients.	60 minutes
Secondary	adenomas per colonoscopy(APC)	APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.	60 minutes
Secondary	patient-level AMR(pAMR)	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	60 minutes