Use of Strattice Mesh in Paraesophageal Hernia Surgery

NCT01678157 | Completed DMC

• 1 other identifier: 0314-11-FB
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hernia recurrence

  A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any

  1 year post-surgery

Secondary Outcomes (1)

• Recurrence of reflux symptoms

  2 weeks, 6 months and 1 year post-surgery

Study Arms (1)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• LifeCell: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitry Oleynikov, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 3, 2012
• Study Start: March 5, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

US (1)