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

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

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Internal Hernia Paraesophageal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Recurrence of hiatal hernia or GERD symptoms

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

LifeCell

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Jan 28, 2013
Registry last updated: Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed