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

August 30, 2023 updated by: University of Nebraska
To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of hiatal hernia or GERD symptoms
Time Frame: 3+ years after initial surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

LifeCell

Investigators

  • Principal Investigator: Dmitry Oleynikov, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

February 11, 2015

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimated)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0168-12-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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