Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Phase 4

• Conditions: Hiatal Hernia

• Registration Number: NCT02242526
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15
• Primary Completion: 2019-09
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess for reappearance of hiatal hernia and reflux	6 months, 60 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life questionnaire	Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months	Quality of life questionnaire containing 36 questions

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States