Bowel Preparation for Inpatient Colonoscopy | NCT01169220

Studies
Bowel Preparation for Inpatient Colonoscopy

NCT01169220

Sponsor

Santa Clara Valley Health & Hospital System

Status

Completed

Last Update Posted

Oct 5, 2017Actual

Enrollment

55Actual

Phase

Phase 4

Conditions

Gastrointestinal Hemorrhage
Colon Cancer
Diverticulosis

Interventions

Go-Lytely
Go Lytely

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

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

Jul 2010

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jul 20, 2010

First Submission Date that Met QC Criteria

Jul 23, 2010

First Posted Date

Jul 26, 2010Estimated

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

Oct 3, 2017

Last Update Posted Date

Oct 5, 2017Actual

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

This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Split prep	Experimental		Drug: Go Lytely
Whole prep	Active Comparator		Drug: Go-Lytely

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Go-Lytely	Drug	Bowel cleansing agent	Whole prep
Go Lytely

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of colon cleansing		24 hours from study enrollment

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction		24 hours from study enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any diagnosis for which colonoscopy is indicated

Exclusion Criteria:

ileus
severe colitis/toxic megacolon
gastric retention
bowel perforation
gastrointestinal obstruction
gastroparesis that precludes oral bowel preparation
pregnant or lactating women
allergy to polyethylene glycol.
unable to give consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Clara Valley Medical Center		San Jose	California	95128	United States

Type	Date	Date Unknown
Release	Sep 20, 2021
Reset	Oct 15, 2021
Release	Oct 25, 2022
Reset	Nov 15, 2022

Submission Tracking

Estimated Results First Submitted Date

Sep 20, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 20, 2021			Oct 15, 2021
Oct 25, 2022

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage
D003110	Colonic Neoplasms
D004240	Diverticulum

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided