Trial record 18 of 21 for:    Open Studies | "Hernia, Diaphragmatic"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by University of Nebraska.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of Nebraska Identifier:
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013

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.

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 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)

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.


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
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Please refer to this study by its identifier: NCT01776827

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

No publications provided

Responsible Party: University of Nebraska 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:
Hiatal Hernia
Paraesophageal Hernia
Biologic Mesh

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia, Hiatal
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Hernia, Diaphragmatic
Pathological Conditions, Anatomical processed this record on October 13, 2015