Use of Strattice Mesh in Paraesophageal Hernia Surgery

Completed

• Conditions: Paraesophageal Hiatal Hernia; Esophageal Hernia; Hiatal Hernia; Hernia, Paraesophageal; Hernia, Esophageal; Sliding Esophageal Hernia; Sliding Hiatal Hernia

• Registration Number: NCT01678157
• Lead Sponsor: University of Nebraska

Brief Summary

The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair.

Detailed Description

Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (\>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.

Study Timeline

• Study Start: 2012-03-05
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-03
• Primary Completion: 2015-05-01
• Study Completion: 2015-05-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Documented symptomatic paraesophageal hernia.
• Greater than 5 cm hiatal hernia on upper gastrointestinal study.
• Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.
• Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.
• Consenting adult 19 years of age or older
• Must be able to participate in follow-up evaluation.
• Free of cognitive impairment

Exclusion Criteria

• Children and adolescents (19 years of age or younger).
• Pregnant and breast feeding patients.
• Vulnerable subjects such as pregnant women, children less than 19 years age, and decisionally impaired persons.
• Patients with previous operation of the esophagus or stomach.
• Patients with associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease).
• Patients with emergent operation for acute gastric volvulus.
• Patients with known sensitivity to porcine material.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	1 year post-surgery	A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any

Secondary Outcome Measures

Name	Time	Method
Recurrence of reflux symptoms	2 weeks, 6 months and 1 year post-surgery	Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test

Trial Locations

Locations (1)

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