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NCT Number: NCT04797065

9 Minutes for Tandem Colonoscopy Withdrawal

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.

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Key information

Conditions

Colon Polyp Colonic Polyps Colorectal Adenoma Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. adenoma miss rate(AMR)

    Time frame: 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 outcomes

  1. advanced adenoma miss rate(AAMR)

    Time frame: 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.

  2. adenoma detection rate(ADR)

    Time frame: 60 minutes

    ADR is the number of patients with at least one adenoma, divided by the total number of patients.

  3. adenomas per colonoscopy(APC)

    Time frame: 60 minutes

    APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.

  4. patient-level AMR(pAMR)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Affiliated Hospital of North Sichuan Medical College
  • Heilongjiang Provicial 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 Affilated Hospital of the Medical College, Shihezi University
  • The First Affiliated Hospital of Dalian Medical University
  • The General Hospital of Eastern Theater Command
  • The Second Hospital of Hebei Medical University
  • Yantaishan Hospital of Yantai City, Yantai, China
  • Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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