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

Xijing Hospital of Digestive Diseases

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hiatal Hernia

Treatments: Procedure: Biological patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02328248

HH-001

Details and patient eligibility

About

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

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups, including a placebo group

Biological patch

Experimental group

Description:

Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically

Treatment:

Procedure: Biological patch

Plastic patch

Placebo Comparator group

Description:

Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically