NCT00786084|UnknownDMC
Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
PEH
Randomized Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestine Submucosa (SIS)
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PEH
Randomized Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestine Submucosa (SIS)
Sponsor study identifier
observational
108
1 country
4
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 4, 2008
Actual (reported)November 5, 2008
Actual (reported)July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To determine the medium/long-term effect of SIS on recurrence rates after laparoscopic PEH repair.
One year
Determine the objective durability of laparoscopic PEH repair with and without SIS
One year
Determine medium/long-term symptomatic outcomes of laparoscopic PEH repair with and without SIS
One year
Determine medium/long-term QOL outcomes of laparoscopic PEH repair with and without SIS
One year
Determine the incidence of long-term complications of SIS mesh for PEH repair (i.e. dysphagia, erosion, infection)
One year
Determine the durability of laparoscopic paraesophageal hernia repair with regard to a) anatomic recurrence b) symptom control
One year
Phase I patients who had a paraesophageal hernia repair with synthetic mesh.
Phase I patients who had a paraesophageal hernia repair with small intestine submucosa mesh.
Prior enrollment in the Phase I study.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Oregon Health & Science University
Portland, Oregon, 92701-3098, United States
The Oregon Clinic, PC
Portland, Oregon, 97227-1655, United States
University of Washington
Seattle, Washington, 98105, United States
Oelschlager BK, Pellegrini CA, Hunter J, Soper N, Brunt M, Sheppard B, Jobe B, Polissar N, Mitsumori L, Nelson J, Swanstrom L. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surg. 2006 Oct;244(4):481-90. doi: 10.1097/01.sla.0000237759.42831.03.
None retained.
Brant K Oelschlager, MD
University of Washington
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 1, 2009
Record last verified: 2009-09
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Source: ClinicalTrials.gov.
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