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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02328248
Other study ID # HH-001
Secondary ID
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


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
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