A Novel Clinically Usable Point Score To Prejudge The Com... | NCT02105025

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

NCT02105025

Sponsor

Air Force Military Medical University, China

Status

Completed

Last Update Posted

May 6, 2014Estimated

Enrollment

612Actual

Phase

Not provided

Conditions

Insertion Time

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 4, 2014

First Posted Date

Apr 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2014

Last Update Posted Date

May 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanglin Pan, Associated professor, Air Force Military Medical University, ChinaPrincipal Investigator

Lead Sponsor

Air Force Military Medical University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

612Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopic center, Xi jing Hospital of Digestive		Xi’an	Shanxi	710032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25886845	Derived	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.