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

Cook Group Incorporated1 site in 1 country150 target enrollmentJuly 2002

ConditionsHernia Paraesophageal Hernia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hernia
Sponsor: Cook Group Incorporated
Enrollment: 150
Locations: 1
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

July 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Eligibility 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