Hiatal Hernia
Conditions
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
Interventions
PROCEDUREBiological patch
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of complications in all case | five years |
Outcome results
None listed