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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328248
Recruitment Status : Unknown
Verified December 2014 by Xiaonan Liu, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaonan Liu, Xijing Hospital of Digestive Diseases

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.

Condition or disease Intervention/treatment Phase
Hiatal Hernia Procedure: Biological patch Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
Study Start Date : July 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biological patch
Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically
Procedure: Biological patch
Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically

Placebo Comparator: Plastic patch
Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically



Primary Outcome Measures :
  1. The incidence of complications in all case [ Time Frame: five years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328248


Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
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Study Chair: Xiaonan Liu, Ph.D Xijing Hospital
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Responsible Party: Xiaonan Liu, associate professor, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02328248    
Other Study ID Numbers: HH-001
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic