Long-term Outcome of Laparoscopic Hiatal Hernia Repair Wi... | NCT01776827

Studies
Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital

NCT01776827

Sponsor

University of Nebraska

Status

Completed

Last Update Posted

Sep 5, 2023Actual

Enrollment

69Actual

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease
Hiatal Hernia
Paraesophageal Hernia

Interventions

Not provided

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

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 2023

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

May 22, 2012Actual

Primary Completion Date

Jun 1, 2014Actual

Completion Date

Feb 11, 2015Actual

First Submitted Date

Jan 23, 2013

First Submission Date that Met QC Criteria

Jan 25, 2013

First Posted Date

Jan 28, 2013Estimated

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 30, 2023

Last Update Posted Date

Sep 5, 2023Actual

Name	Class
LifeCell	INDUSTRY

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

To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh.

Detailed Description

To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh. A barium swallow test with x-rays will be performed to look for recurrence of hiatal hernia. If the participants are symptomatic, additional medical therapy will be provided as deemed appropriate.

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

69Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of hiatal hernia or GERD symptoms	Patients will be questioned concerning their gastroesophageal reflux symptoms and hernia recurrence will be assessed using a barium swallow and x-rays.	3+ years after initial surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who underwent paraesophageal hernia repair at UNMC.
Greater than 19 years of age
Not pregnant

Exclusion Criteria:

Children and adolescents
Pregnant and breast-feeding patients
Vulnerable subjects such as decisionally impaired persons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent paraesophageal hernia repair at the University of Nebraska Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dmitry Oleynikov, MD	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D006551	Hernia, Hiatal

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided