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Use of Strattice Mesh in Paraesophageal Hernia Surgery

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
Dmitry Oleynikov MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01678157
First received: August 29, 2012
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Esophageal Hernia
Hernia, Esophageal
Hernia, Paraesophageal
Hiatal Hernia
Paraesophageal Hiatal Hernia
Sliding Esophageal Hernia
Sliding Hiatal Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Hernia recurrence [ Time Frame: 1 year post-surgery ] [ Designated as safety issue: No ]
    A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any


Secondary Outcome Measures:
  • Recurrence of reflux symptoms [ Time Frame: 2 weeks, 6 months and 1 year post-surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: March 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678157

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5126
Sponsors and Collaborators
University of Nebraska
LifeCell
  More Information

No publications provided

Responsible Party: Dmitry Oleynikov MD, Professor of Surgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT01678157     History of Changes
Other Study ID Numbers: 314-11FB
Study First Received: August 29, 2012
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration
United States: University of Nebraska Institutional Review Board

Keywords provided by University of Nebraska:
Esophageal Hernia
Hernia, Esophageal
Hernia, Paraesophageal
Hiatal Hernia
 Paraesophageal Hiatal Hernia
Sliding Esophageal Hernia
Sliding Hiatal Hernia

Additional relevant MeSH terms:
Esophageal Diseases
Hernia
Hernia, Hiatal
Gastrointestinal Diseases
 Digestive System Diseases
Pathological Conditions, Anatomical
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on May 22, 2013