Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

This study has been completed.

First Received: January 4, 2006 Last Updated: October 17, 2007 History of Changes

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00272922

Purpose

The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.

Condition	Intervention
Hernia Paraesophageal Hernia	Device: hernia repair

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Cook:

Estimated Enrollment:	150
Study Start Date:	July 2002
Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years
Documented symptomatic paraesophageal hernia
Ability to participate in follow-up evaluation
Has a telephone
Free of cognitive or speech impairment

Exclusion Criteria:

Patients requiring intra-operative conversion to an open procedure
Unable to close the crura primarily
Short esophagus that requires the surgeon to perform a lengthening procedure
Previous operation of the esphagus or stomach
Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
Intraoperative full-thickness perforation of the esophagus
Emergent operation for acute volvulus
Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or < 70% propagation of peristaltic waves in the distal esophagus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272922

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Cook

Investigators

Principal Investigator:

Brant K Oelschlager, MD

University of Washington

More Information

No publications provided

Study ID Numbers:	02-1931-A-01 (Institution #)
Study First Received:	January 4, 2006
Last Updated:	October 17, 2007
ClinicalTrials.gov Identifier:	NCT00272922 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: University of Washington Human Subjects Review Committee

Keywords provided by Cook:

Biomaterials
Paraesophageal Hernia
Laparoscopy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia, Hiatal
Hernia
Hernia, Diaphragmatic

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia, Hiatal
Hernia
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on September 01, 2009