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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01776827

Enrollment

Registered

2013-01-28

Start date

2012-05-22

Completion date

2015-02-11

Last updated

2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease, Hiatal Hernia, Paraesophageal Hernia

Keywords

GERD, Hiatal Hernia, Paraesophageal Hernia, Biologic Mesh

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results