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Completed

NCT Number: NCT01678157

Use of Strattice Mesh in Paraesophageal Hernia Surgery

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Hernia recurrence

    Time frame: 1 year post-surgery

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

Secondary outcomes

  1. Recurrence of reflux symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • LifeCell

Registry information

Official study title

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

Acronym: Strattice

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 3, 2012
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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