Text Size

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

This study is currently recruiting participants.
Verified January 2013 by University of Nebraska
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01776827
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Recurrence of hiatal hernia or GERD symptoms [ Time Frame: 3+ years after initial surgery ] [ Designated as safety issue: No ]
    Patients will be questioned concerning their gastroesophageal reflux symptoms and hernia recurrence will be assessed using a barium swallow and x-rays.


Estimated Enrollment: 70
Study Start Date: May 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776827

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Ernie Prentice, Ph.D.         irbora@unmc.edu    
Principal Investigator: Dmitry Oleynikov, M.D.            
Sponsors and Collaborators
University of Nebraska
LifeCell
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01776827     History of Changes
Other Study ID Numbers: 168-12-FB
Study First Received: January 23, 2013
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
GERD
Hiatal Hernia
Paraesophageal Hernia
Biologic Mesh

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

ClinicalTrials.gov processed this record on May 16, 2013