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Completed

NCT Number: NCT03399045

9 Minutes for Colonoscopy Withdrawal

A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.

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Key information

Conditions

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

Age range

40 year–85 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 40-85.
  • Patients who have indications for screening, surveillance and diagnostic colonoscopy.
  • Patients who have signed inform consent form

Exclusion criteria

  • Patients who have undergone colonic resection
  • Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
  • Patients with severe chronic cardiopulmonary and renal disease.
  • Patients who are unwilling or unable to consent.
  • Patients who are not suitable for colonoscopy
  • Patients who received urgent or therapeutic colonoscopy
  • Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
  • Patients who are taking aspirin, clopidogrel or other anticoagulants
  • Patients with Aronchick score > 3

Treatment and study plan

9-minute withdrawal

Procedure

Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw

6-minute withdrawal

Procedure

Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw

Primary outcomes

  1. adenoma detection rate(ADR)

    Time frame: 30mins

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

Secondary outcomes

  1. adenomas per colonoscopy(APC)

    Time frame: 30mins

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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Changzhi People's Hospital
  • First Affiliated Hospital of Harbin Medical University
  • Ningbo Medical Center Lihuili Hospital
  • No.85 Hospital, Changning, Shanghai, China
  • Qinghai People's Hospital
  • Seventh Medical Center of PLA Army General Hospital
  • Shaanxi Provincial People's Hospital
  • Shanghai 8th People's Hospital
  • The First Affilated Hospital of the Medical College, Shihezi University
  • The First Affiliated Hospital of Dalian Medical University
  • The Second Clinical Medical College of Jinan University
  • The Third People's Hospital of Datong
  • Yantaishan Hospital of Yantai City

Registry information

Official study title

Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2018
Registry last updated
Jan 2, 2020

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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