Randomized Control Trial on Seprafilm and Guardix in Prev... | NCT02168426

Studies
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

NCT02168426

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Patient Under Going Colorectal and Stomach Cancer Surgery

Interventions

Guardix
Seprafilm

Countries

South Korea

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

Aug 2015

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

Aug 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 19, 2014

First Posted Date

Jun 20, 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

Aug 28, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Won-Suk Lee, Won-Suk Lee, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

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

The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Guardix	Active Comparator	6g per body	Procedure: Guardix Procedure: Seprafilm
Seprafilm	Active Comparator	1 sheet per body	Procedure: Guardix Procedure: Seprafilm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Guardix	Procedure	Applying 6g of guardix during abdominal surgery	Guardix Seprafilm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ileus rate	Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations	within 60 days

Secondary Outcomes

Measure	Description	Time Frame
adverse effect rate		within 60 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of GI cancer
Operable

Exclusion Criteria:

Withdrew consent
Pregnant
Ascites
Distant metastasis
Liver dysfunction (serum total bilirubin >2.0 mg/dL)
Renal failure (serum creatinine >1.5 mg/dL)
A past history of small bowel obstruction.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000588779	guardix
C118198	Seprafilm

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided