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Study of Paraesophageal Hernia Repair With Small Intestine Submucosa

NCT00786084 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2009-10-01

No results posted yet for this study

Summary

In 2006 this research group reported their initial findings of a multi-center prospective trial comparing primary repair and primary repair buttressed with a biologic mesh made from porcine small intestinal submucosa (SIS). We were able to accrue 108 patients from 7/2002-3/2005 and followed each patient over 6 months and performed an UGI to check the durability of the repair and rule out a recurrence. The results suggested a significant benefit for the use of SIS mesh in the short-term, with the primary group having a 26% recurrence rate and the mesh group a 9% recurrence rate.

While these results are encouraging, it is important to know what is the durability and the longer term benefits of the use of SIS mesh. For this reason we propose a follow-up of the original study patients with the same outcome measures (symptom questionnaire, SF-36, and UGI). This should give us a very good idea about the long-term success of laparoscopic PEH repair with primary and SIS mesh.

Conditions

  • Hiatal Hernia
  • Paraesophageal Hernia

Sponsors & Collaborators

  • Cook Biotech Incorporated

    collaborator INDUSTRY

  • Washington University School of Medicine

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • The Oregon Clinic

    collaborator OTHER

  • University of Washington

    lead OTHER

Principal Investigators

  • Brant K Oelschlager, MD · University of Washington

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00786084 on ClinicalTrials.gov