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Use of Strattice Mesh in Paraesophageal Hernia Surgery (Strattice)

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ClinicalTrials.gov Identifier: NCT01678157
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : December 7, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Esophageal Hernia Hernia, Esophageal Hernia, Paraesophageal Hiatal Hernia 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 Design

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia
Study Start Date : March 2012
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dmitry Oleynikov MD, Professor of Surgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT01678157     History of Changes
Other Study ID Numbers: 314-11FB
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic