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

Completed

• Conditions: Paraesophageal Hernia; Gastroesophageal Reflux Disease; Hiatal Hernia

• Registration Number: NCT01776827
• Lead Sponsor: University of Nebraska

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-05-22
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Primary Completion: 2014-06-01
• Study Completion: 2015-02-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of hiatal hernia or GERD symptoms	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.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States