Study of Paraesophageal Hernia Repair With Small Intestine Submucosa

NCT00786084 | Unknown DMC

• 1 other identifier: 21065-A
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Hiatal hernia; PEH; paraesophageal hernia; synthetic mesh; small intestine submucosa

Outcome Measures

Primary Outcomes (1)

• To determine the medium/long-term effect of SIS on recurrence rates after laparoscopic PEH repair.

  One year

Secondary Outcomes (5)

• 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

Study Arms (2)

1

Phase I patients who had a paraesophageal hernia repair with synthetic mesh.

2

Phase I patients who had a paraesophageal hernia repair with small intestine submucosa mesh.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prior enrollment in the Phase I study.

You may qualify if:

• Prior enrollment in Phase I study.

You may not qualify if:

• None.

Sponsors & Collaborators

• University of Washington: lead
• Cook Biotech Incorporated: collaborator
• Washington University School of Medicine: collaborator
• Oregon Health and Science University: collaborator
• The Oregon Clinic: collaborator

Study Sites (4)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Oregon Health & Science University

Portland, Oregon, 92701-3098, United States

Location

The Oregon Clinic, PC

Portland, Oregon, 97227-1655, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 16998356 BACKGROUND

Biospecimen

Retention: NONE RETAINED

None retained.

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Brant K Oelschlager, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 1, 2009

Record last verified: 2009-09

Locations

US (4)