Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
Status unconfirmed
Conditions studied: Hiatal Hernia, Paraesophageal Hernia
In brief
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.
Key facts
- Study ID
- NCT00786084
- Run by
- University of Washington
- People needed
- 108
- Starts
- 2008-09-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2009-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior enrollment in Phase I study.
You may not qualify if…
- None.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
- Oregon Health & Science University — Portland, Oregon, United States
- The Oregon Clinic, PC — Portland, Oregon, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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