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NCT01776827 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01776827
Other study ID # 0168-12-FB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 22, 2012
Est. completion date February 11, 2015

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To study the long term outcome of Laparoscopic Hiatal Hernia Repair with human acellular dermal matrix Alloderm (LifeCell, Branchburg, NJ) mesh.

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date February 11, 2015
Est. primary completion date June 1, 2014
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (2)
Lead Sponsor Collaborator
University of Nebraska LifeCell

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence of hiatal hernia or GERD symptoms 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
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