9 Minutes for Tandem Colonoscopy Withdrawal

NCT04797065 | Completed DMC

• 1 other identifier: withdrawal time-2
• Study Type: interventional
• Target: 733
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyp; Colorectal Adenoma

Keywords

withdrawal time; adenoma miss rate; tandem colonoscopy; adenoma detection rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• advanced adenoma miss rate(AAMR)

  60 minutes

• adenoma detection rate(ADR)

  60 minutes

• adenomas per colonoscopy(APC)

  60 minutes

• patient-level AMR(pAMR)

  60 minutes

Study Arms (2)

6-minute then 9-minute withdrawal

EXPERIMENTAL

Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the segmental withdrawal. At 6-minute withdrawal, the left colon, transverse colon and right colon will take 2 minutes each. Then at 9-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 3 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.

Procedure: 6-minute then 9-minute withdrawal

9-minute then 6-minute withdrawal

ACTIVE COMPARATOR

Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the segmental withdrawal. At 9-minute withdrawal, the left colon, transverse colon and right colon will take 3 minutes each. Then at 6-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 2 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.

Procedure: 9-minute then 6-minute withdrawal

Interventions

6-minute then 9-minute withdrawal PROCEDURE

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.

6-minute then 9-minute withdrawal

9-minute then 6-minute withdrawal PROCEDURE

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.

9-minute then 6-minute withdrawal

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose age is between 40-75.
• Patients who have indications for screening
• Patients who have signed inform consent form.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (3)

• 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.

  PMID: 33220526 BACKGROUND

• 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.

  PMID: 30738046 BACKGROUND

• Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.

  PMID: 36219172 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaoshen Li, M.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Dept

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: March 1, 2021
• Primary Completion: November 5, 2021
• Study Completion: December 5, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

CN (1)