Study of Paraesophageal Hernia Repair With Small Intestine Submucosa (PEH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Cook Biotech Incorporated
Washington University School of Medicine
Oregon Health and Science University
The Oregon Clinic
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00786084
First received: November 4, 2008
Last updated: September 30, 2009
Last verified: September 2009
  Purpose

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.


Condition
Hiatal Hernia
Paraesophageal Hernia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Randomized Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestine Submucosa (SIS)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To determine the medium/long-term effect of SIS on recurrence rates after laparoscopic PEH repair. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the objective durability of laparoscopic PEH repair with and without SIS [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Determine medium/long-term symptomatic outcomes of laparoscopic PEH repair with and without SIS [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Determine medium/long-term QOL outcomes of laparoscopic PEH repair with and without SIS [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Determine the incidence of long-term complications of SIS mesh for PEH repair (i.e. dysphagia, erosion, infection) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Determine the durability of laparoscopic paraesophageal hernia repair with regard to a) anatomic recurrence b) symptom control [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

None retained.


Estimated Enrollment: 108
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Traditionally paraesophageal hernias were repaired by thoracotomy or laparotomy with morbidity around 20% and mortality of 2%.1,2 The advent and later popularization of antireflux operations via the minimally invasive approach led to the development of a similar (laparoscopic) approach to the treatment of paraesophageal hernia. This approach called for the excision of the sac, a thorough esophageal mobilization, primary closure of the hiatus and a Nissen fundoplication. 3,4 Laparoscopy appears to have some of the benefits of thoracotomy (the hiatus can be accessed easier, the esophagus can be dissected under direct vision and high mobilization of the esophagus is possible) and some of the advantages of the laparotomy (less morbidity, no need to collapse the lung, no need for postoperative chest tube). In fact, most PEH are currently repaired via a laparoscopic approach.

Hashemi et al in 2000 reported that patients who had had a repair of a paraesophageal hernia via the laparoscopic approach had a higher recurrence rate when compared to those operated on via thoracotomy and laparotomy.5 The only other study comparing open and laparoscopic repair revealed a higher incidence of recurrence in the open repair group (8% vs. 0%),6 but was also based solely on symptoms. Case series of LPEHR which evaluate recurrent hiatal hernia by x-ray or endoscopy have found the recurrence rate to be between 12-42%,3,5,7 suggesting significant room for improvement.

It is not surprising that primary repair of the paraesophageal hiatal hernia by suturing the pillars of the diaphragm together under tension is at significant risk for disruption. With the development and wide application of mesh materials for tension-free repair of inguinal and ventral hernias, many surgeons have applied the technique of tension-free closure with a mesh to the hiatal hernia. Two randomized trials have demonstrated a significant reduction in recurrence rates by using synthetic mesh in large hiatal hernia repairs.8,9 However, there are potential problems introduced by using synthetic mesh at the dynamic hiatus such as mesh erosion, ulceration, stricture, and dysphagia.9,10,11 Recently, a number of biomaterials have been developed for hernia repair. The idea behind them is that a biologic scaffold, usually containing extracellular collagen, serves as a temporary matrix, thus strengthening a natural hernia closure.12,13 One such mesh is derived from porcine small intestinal submucosa (SIS) (Cook Surgical Indianapolis, IN). A pilot study using SIS for PEH repair suggested that is was safe and possibly effective in reducing recurrence.14 We then organized and carried out a multi-center randomized trial comparing primary repair of the crura and buttressing a primary repair with SIS mesh during laparoscopic PEH repair. The results at 6 months after operation demonstrated a nearly 3-fold reduction in the recurrence rate with the use of mesh (26% to 9%).15 Furthermore, there were no mesh related complications such as dysphagia, infection, or erosion. These results have been met with tempered enthusiasm in the surgical community. The only question in many surgeon's minds is whether buttressed repair of the hiatus is durable. To answer this question we need to complete longer term follow-up in these patients.

The aim of this study is to determine if the use of SIS to reinforce the closure of the hiatus in patients with paraesophageal hernias results in a lower recurrence rate at 2.5-5 years after operation, and results in improved outcomes, without an increase in the complication rate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prior enrollment in the Phase I study.

Criteria

Inclusion criteria:

  • Prior enrollment in Phase I study.

Exclusion criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786084

Locations
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 92701-3098
The Oregon Clinic, PC
Portland, Oregon, United States, 97227-1655
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Cook Biotech Incorporated
Washington University School of Medicine
Oregon Health and Science University
The Oregon Clinic
Investigators
Principal Investigator: Brant K Oelschlager, MD University of Washington
  More Information

Publications:
Responsible Party: Brant Oelschlager, MD/Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00786084     History of Changes
Other Study ID Numbers: 21065-A
Study First Received: November 4, 2008
Last Updated: September 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Hiatal hernia
PEH
paraesophageal hernia
synthetic mesh
small intestine submucosa

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

ClinicalTrials.gov processed this record on October 19, 2014