Trial record 4 of 181 for:    Open Studies | Hernia NOT disc

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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014