Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias
NCT ID: NCT02328248
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2014-07-31
2016-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biological patch
Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically
Biological patch
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
Plastic patch
Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically
No interventions assigned to this group
Interventions
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Biological patch
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Xiaonan Liu
associate professor
Principal Investigators
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Xiaonan Liu, Ph.D
Role: STUDY_CHAIR
Xijing Hospital
Other Identifiers
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HH-001
Identifier Type: -
Identifier Source: org_study_id