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

Phase 2

• Conditions: Hiatal Hernia

• Registration Number: NCT02328248
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief 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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-28
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-26
• Last Update Submitted: 2014-12-26
• Study First Posted: 2014-12-31
• Last Update Posted: 2014-12-31
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

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

Inclusion Criteria

• Clinical diagnosis of Hiatal hernia
• Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
• randomly select patch agreed by patients and family members

Exclusion Criteria

• Poor general condition
• severe organ dysfunction
• No-tolerate anesthesia
• No-suitable for operation
• Emergency operation needed
• Serious adverse events appeared during the operation
• Sever intraperitoneal adhesion existed
• glucocorticoid with long-term use
• immunocompromised patients
• spirit disease patients
• automatically exit
• women who pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of complications in all case	five years