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

Not Applicable

Completed

• Conditions: Hernia; Paraesophageal Hernia

• Registration Number: NCT00272922
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-09
• Study Completion: 2006-07
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-17
• Last Update Posted: 2007-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States