Use of Strattice Mesh in Paraesophageal Hernia Surgery (Strattice)

Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults over 19 years of age with paraesophageal hernia greater than 5 cm.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Documented symptomatic paraesophageal hernia; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of reflux symptoms	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	2 weeks, 6 months and 1 year post-surgery

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: LifeCell
• Investigators: Principal Investigator: Dmitry Oleynikov, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimated): September 3, 2012

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hiatal Hernia; Esophageal Hernia; Hernia, Esophageal; Hernia, Paraesophageal; Paraesophageal Hiatal Hernia; Sliding Esophageal Hernia; Sliding Hiatal Hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: 0314-11-FB