Usage of Biological Patch Versus Plastic in the Laparosco... | NCT02328248

Studies
Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias

NCT02328248

Sponsor

Xijing Hospital of Digestive Diseases

Status

Unknown status

Last Update Posted

Dec 31, 2014Estimated

Enrollment

150Estimated

Phase

Phase 2Phase 3

Conditions

Hiatal Hernia

Interventions

Biological patch

Countries

Not provided

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Jul 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Nov 28, 2014

First Submission Date that Met QC Criteria

Dec 26, 2014

First Posted Date

Dec 31, 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

Dec 26, 2014

Last Update Posted Date

Dec 31, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaonan Liu, associate professor, Xijing Hospital of Digestive DiseasesPrincipal Investigator

Lead Sponsor

Xijing Hospital of Digestive DiseasesOTHER

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 this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.

Detailed Description

observation indicator:

incidence rate of complications,
postoperative hospital stay
readmission rate in 1st month after operation
recurrence rate after operation
hospitalization costs
Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological patch	Experimental	Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically	Procedure: Biological patch
Plastic patch	Placebo Comparator	Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological patch	Procedure	Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically	Biological patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of complications in all case		five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Hiatal hernia
Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
randomly select patch agreed by patients and family members

Exclusion Criteria:

Poor general condition
severe organ dysfunction
No-tolerate anesthesia
No-suitable for operation
Emergency operation needed
Serious adverse events appeared during the operation
Sever intraperitoneal adhesion existed
glucocorticoid with long-term use
immunocompromised patients
spirit disease patients
automatically exit
women who pregnant

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Xiaonan Liu, Ph.D	Xijing Hospital	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D006551	Hernia, Hiatal

Ancestor Terms

ID	Term
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia
D006547	Hernia
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided