NCT05069571

Brief Summary

Exploring the relationship between the percentage of overspeed of colonoscopy withdrawal and the rate of adenoma detection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

September 24, 2021

Last Update Submit

September 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    3 months

Secondary Outcomes (1)

  • Proportion of withdrawal overspeed

    3 months

Interventions

Collecting the colonoscopy videos and analyzing the correlation between withdrawal overspeed proportion and adenoma detection rate.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients need to receive the colonoscopy examination.

You may qualify if:

  • Males or females who are over 18 years old (inclusive);
  • Enteroscopy and related examinations are needed to further clarify the characteristics of digestive tract diseases;
  • Able to read, understand and sign the informed consent form;
  • The researcher believes that the subject can understand the process of the clinical research, is willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

You may not qualify if:

  • Participated in other clinical trials, signed an informed consent form and within the follow-up period of other clinical trials;
  • Abuse of drugs or alcohol or mental disorders in the last 5 years;
  • Women during pregnancy or breastfeeding;
  • Subjects with previous history of bowel surgery;
  • The investigator believes that the subject is not suitable for enteroscopy and related examinations;
  • The investigator believes that the subject is not suitable for high-risk diseases or other special circumstances to participate in clinical trials.
  • Patients with gastrointestinal bleeding;
  • Known or highly suspected allergy to any ingredient of bowel cleansing agent;
  • Restricted activities or any mental or physical condition impairs their ability to drink intestinal cleansing preparations;
  • Known or suspected intestinal obstruction or perforation, toxic megacolon, most colectomy, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure or end, renal insufficiency, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Honggang Yu, Doctor

CONTACT

Liwen Yao, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 6, 2021

Study Start

March 1, 2020

Primary Completion

November 1, 2021

Study Completion

February 1, 2022

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations