Evaluation of the Quality of Bowel Cleansing in a Real Cl... | NCT02839824

Studies
Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting

NCT02839824

Sponsor

Casen Recordati S.L.

Status

Completed

Last Update Posted

Jan 26, 2018Actual

Enrollment

412Actual

Phase

Not provided

Conditions

Bowel Preparation for Colonoscopy

Interventions

Bowel preparation

Countries

Spain

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

Jan 2018

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

Sep 15, 2016Actual

Primary Completion Date

Mar 6, 2017Actual

Completion Date

Mar 6, 2017Actual

First Submitted Date

Jul 14, 2016

First Submission Date that Met QC Criteria

Jul 18, 2016

First Posted Date

Jul 21, 2016Estimated

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

Jan 24, 2018

Last Update Posted Date

Jan 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials.

For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

412Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bowel preparation	Procedure	Bowel preparation for bowel cleansing in a real clinical practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with adequate colon cleansing	Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5	Through study completion, an average of 6 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients with adequate colon cleansing of different administration schedules	Percentage of patients with punctuation in BBPS ≥ 5 in each administration schedule	Through study completion, an average of 6 months
Identify factors influencing bowel cleansing quality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80 years
Subjects who have been performed a colonoscopy

Exclusion Criteria:

Subjects being previously performed colon surgery.
Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy.
Subjects with extreme limitations due to disease.
Subjects in who Boston Bowel Preparation Scale (BBPS) is not available
Subjects who have undergone a colonoscopy during their participation in another clinical study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients who have been performed a colonoscopy and who have received a bowel cleansing agent according to the investigator criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana Bargalló, MD	Clínica de Medicina Integral Diagonal, Gastroenterology department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica de Medicina Integral Diagonal		Esplugues de Llobregat	Barcelona	08950	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002400	Cathartics

Ancestor Terms

ID	Term
D005765	Gastrointestinal Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided