NCT02328248

Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias

Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.

Detailed description

observation indicator: 1. incidence rate of complications, 2. postoperative hospital stay 3. readmission rate in 1st month after operation 4. recurrence rate after operation 5. hospitalization costs 6. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Conditions

• Hiatal Hernia

Interventions

Type	Name	Description
PROCEDURE	Biological patch	Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2014-12-31
• Last updated: 2014-12-31