Hiatal Hernia Clinical Trial
Official title:
Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | December 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital of Digestive Diseases |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of complications in all case | five years | Yes |
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