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

Xijing Hospital of Digestive Diseases150 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Hiatal Hernia

Interventions

Biological patchPROCEDURE

Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidence of complications in all case

Time frame: five years

Data from ClinicalTrials.gov

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