Use of Strattice Mesh in Paraesophageal Hernia Surgery

NCT ID: NCT01678157

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-05
• Study Completion Date: 2015-05-01

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.

Conditions

Esophageal Hernia; Hernia, Esophageal; Hernia, Paraesophageal; Hiatal Hernia; Paraesophageal Hiatal Hernia; Sliding Esophageal Hernia; Sliding Hiatal Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Documented symptomatic paraesophageal hernia

1. Documented symptomatic paraesophageal hernia.

2. Greater than 5 cm hiatal hernia on upper gastrointestinal study.

3. Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.

4. 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.

5. Consenting adult 19 years of age or older

6. Must be able to participate in follow-up evaluation.

7. Free of cognitive impairment

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeCell

INDUSTRY

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dmitry Oleynikov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0314-11-FB

Identifier Type: -

Identifier Source: org_study_id