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

Primary Purpose

Hiatal Hernia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Biological patch
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiatal Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Biological patch

    Plastic patch

    Arm Description

    Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically

    Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically

    Outcomes

    Primary Outcome Measures

    The incidence of complications in all case

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2014
    Last Updated
    December 26, 2014
    Sponsor
    Xijing Hospital of Digestive Diseases
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02328248
    Brief Title
    Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias
    Official Title
    Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xijing Hospital of Digestive Diseases

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    observation indicator: incidence rate of complications, postoperative hospital stay readmission rate in 1st month after operation recurrence rate after operation hospitalization costs 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hiatal Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Biological patch
    Arm Type
    Experimental
    Arm Description
    Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically
    Arm Title
    Plastic patch
    Arm Type
    Placebo Comparator
    Arm Description
    Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically
    Intervention Type
    Procedure
    Intervention Name(s)
    Biological patch
    Intervention Description
    Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
    Primary Outcome Measure Information:
    Title
    The incidence of complications in all case
    Time Frame
    five years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaonan Liu, Ph.D
    Organizational Affiliation
    Xijing Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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