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

Hiatal Hernia Clinical Trial

Official title:

Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02328248
• Other study ID #: HH-001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 28, 2014
• Last updated: December 26, 2014
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia, Hiatal
• Hiatal Hernia

Intervention

Procedure:
• Biological patch
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of complications in all case		five years	Yes