NCT02105025

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
612

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

March 28, 2014

Last Update Submit

May 5, 2014

Conditions

Keywords

insertion time

Outcome Measures

Primary Outcomes (1)

  • Cecal intubation time

    Total time of colonoscope intubation from anus to cecum.

    up to 4 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopic center, Xi jing Hospital of Digestive

Xi’an, Shanxi, 710032, China

Location

Related Publications (1)

  • Jia H, Wang L, Luo H, Yao S, Wang X, Zhang L, Huang R, Liu Z, Kang X, Pan Y, Guo X. Difficult colonoscopy score identifies the difficult patients undergoing unsedated colonoscopy. BMC Gastroenterol. 2015 Apr 9;15:46. doi: 10.1186/s12876-015-0273-7.

Related Links

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 7, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations