Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Hiatal Hernia Clinical Trial

Official title:

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242526
• Other study ID #: SB-568818
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: August 2020

Study information

• Verified date: October 2018
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Description:

Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: August 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female gender

• Age>18 years

• Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.

• Able to give informed consent

• Able and willing to participate in follow-up evaluations

• Upper GI with a documented hiatal hernia greater than 5cm

• Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.

Exclusion Criteria:

• Previous surgery of the esophagus and/or the stomach

• Emergent operation for acute gastric volvulus or strangulation

• Biopsy consistent with malignancy

• Body Mass Index (BMI) over 35kg/m2

• Inability to perform primary closure of crura

• Active smoking

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Device:
• Parietex™ Composite Hiatal Mesh, North Haven, CT
Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.
• Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess for reappearance of hiatal hernia and reflux	Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.	6 months, 60 months
Secondary	Quality of Life questionnaire	Quality of life questionnaire containing 36 questions	Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months