A Novel Clinically Usable Point Score To Prejudge The Complexity Of Colonoscopy

May 5, 2014 updated by: Yanglin Pan, Air Force Military Medical University, China
Colonoscopy is the current common method for management of colorectal diseases, and effectiveness of colonoscopy associate with complication rate. A lot of patients were failed because of technical difficulty, those required more than 10 min to intubate the cecum are consider as difficult colonoscopy, in such condition, specialized equipment or maneuvers may be required for a successful colonoscopy. Thus, it is important to set up a clinical model to predict the technical difficulty of the examination in preoperational stage.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

612

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Endoscopic center, Xi jing Hospital of Digestive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a prospective study involving only one tertiary center in China. The patients were enrolled from the Endoscopy Center of Xi jing Hospital of Digestive Diseases in China.

Description

Inclusion Criteria:

  • patients aged 18-90 years old who undergoing colonoscopy without sedation

Exclusion Criteria:

  • no bowel preparation or colon cleansing by enema only
  • no need to reach cecum
  • prior finding of severe colon stenosis or obstructing tumour
  • history of colectomy
  • unstable hemodynamics
  • pregnant
  • unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cecal intubation time
Time Frame: up to 4 months
Total time of colonoscope intubation from anus to cecum.
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20131023-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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