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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776827
First Posted: January 28, 2013
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LifeCell
Information provided by (Responsible Party):
Dmitry Oleynikov MD, University of Nebraska
  Purpose
To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh at a University Hospital.

Condition
Gastroesophageal Reflux Disease Hiatal Hernia Paraesophageal Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital

Resource links provided by NLM:


Further study details as provided by Dmitry Oleynikov MD, University of Nebraska:

Primary Outcome Measures:
  • 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.


Enrollment: 69
Study Start Date: May 2012
Study Completion Date: February 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent paraesophageal hernia repair at the University of Nebraska Medical Center.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776827


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
LifeCell
  More Information

Responsible Party: Dmitry Oleynikov MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01776827     History of Changes
Other Study ID Numbers: 168-12-FB
First Submitted: January 23, 2013
First Posted: January 28, 2013
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by Dmitry Oleynikov MD, University of Nebraska:
GERD
Hiatal Hernia
Paraesophageal Hernia
Biologic Mesh

Additional relevant MeSH terms:
Hernia
Gastroesophageal Reflux
Hernia, Hiatal
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic