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

NCT ID: NCT00272922

Last Updated: 2007-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia Paraesophageal Hernia

Keywords

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Biomaterials Paraesophageal Hernia Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hernia repair

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Principal Investigators

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Brant K Oelschlager, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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02-1931-A-01 (Institution #)

Identifier Type: -

Identifier Source: org_study_id