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A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

Primary Purpose

Hiatal Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
Sponsored by
Paracelsus Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiatal Hernia focused on measuring hiatal hernia, pledgets, mesh, hernia recurrence

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)
  • Written informed consent
  • ≥ 18 years of age

  • Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria:

    • > 5cm hiatal hernia
    • 1/3 of the stomach in the thorax

Exclusion Criteria:

  • Lack of patient consent for study participation
  • Lack of consent to study due to linguistic or mental incomprehension
  • Patients in poor general condition (lack of anesthesia ability)
  • Pregnancy
  • Prior surgery on the stomach or gastroesophageal junction
  • Simultaneous surgery because of another illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Sutures only

    Absorbable Mesh

    Pledgeted sutures

    Arm Description

    Patients with a large hiatal hernia undergo the cruroplasty with sutures only. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.

    Patients with a large hiatal hernia undergo the cruroplasty with mesh implantation. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.

    Patients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.

    Outcomes

    Primary Outcome Measures

    Hiatal hernia recurrence rate
    Hiatal hernia recurrence rate documented by gastroscopy

    Secondary Outcome Measures

    Quality of Life evaluated by questionnaire
    Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)
    Symptoms related to Gastroesophageal Reflux Disease (GERD)
    Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.
    Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)
    Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale
    Postoperative complications
    Short - term and long - term complications after treatment
    Length of hospital stay
    Length of hospital stay and mortality rates
    Predictive parameters for treatment response or failure I
    Weight (in kilograms)
    Predictive parameters for treatment response or failure II
    Height (in meters)

    Full Information

    First Posted
    September 17, 2020
    Last Updated
    March 28, 2023
    Sponsor
    Paracelsus Medical University
    Collaborators
    Medical University Innsbruck, Medical University of Vienna, Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04591860
    Brief Title
    A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
    Official Title
    A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2027 (Anticipated)
    Study Completion Date
    May 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Paracelsus Medical University
    Collaborators
    Medical University Innsbruck, Medical University of Vienna, Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh). The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hiatal Hernia
    Keywords
    hiatal hernia, pledgets, mesh, hernia recurrence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh). The study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up 6 months, 1 year, 3 years and 5 years after the operation using standardized questionnaires and gastroscopy.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    165 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sutures only
    Arm Type
    Active Comparator
    Arm Description
    Patients with a large hiatal hernia undergo the cruroplasty with sutures only. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.
    Arm Title
    Absorbable Mesh
    Arm Type
    Active Comparator
    Arm Description
    Patients with a large hiatal hernia undergo the cruroplasty with mesh implantation. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.
    Arm Title
    Pledgeted sutures
    Arm Type
    Active Comparator
    Arm Description
    Patients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.
    Intervention Type
    Device
    Intervention Name(s)
    Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
    Intervention Description
    Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.
    Primary Outcome Measure Information:
    Title
    Hiatal hernia recurrence rate
    Description
    Hiatal hernia recurrence rate documented by gastroscopy
    Time Frame
    6 months, 1 year, 3 years and 5 years after surgery
    Secondary Outcome Measure Information:
    Title
    Quality of Life evaluated by questionnaire
    Description
    Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)
    Time Frame
    Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
    Title
    Symptoms related to Gastroesophageal Reflux Disease (GERD)
    Description
    Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.
    Time Frame
    Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
    Title
    Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)
    Description
    Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale
    Time Frame
    Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
    Title
    Postoperative complications
    Description
    Short - term and long - term complications after treatment
    Time Frame
    6 months, 1 year, 3 years and 5 years after surgery
    Title
    Length of hospital stay
    Description
    Length of hospital stay and mortality rates
    Time Frame
    up to 90 days
    Title
    Predictive parameters for treatment response or failure I
    Description
    Weight (in kilograms)
    Time Frame
    Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
    Title
    Predictive parameters for treatment response or failure II
    Description
    Height (in meters)
    Time Frame
    Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted) Written informed consent ≥ 18 years of age Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria: > 5cm hiatal hernia 1/3 of the stomach in the thorax Exclusion Criteria: Lack of patient consent for study participation Lack of consent to study due to linguistic or mental incomprehension Patients in poor general condition (lack of anesthesia ability) Pregnancy Prior surgery on the stomach or gastroesophageal junction Simultaneous surgery because of another illness
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Weitzendorfer, MD, PhD
    Phone
    +435725551078
    Email
    m.weitzendorfer@salk.at
    First Name & Middle Initial & Last Name or Official Title & Degree
    Oliver O Koch, MD, FEBS
    Phone
    +435725551091
    Email
    o.koch@salk.at

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33567462
    Citation
    Koch O, von Rahden BHA, Wykypiel H, Schoppmann SF, Fugger R, Rosanelli G, Emmanuel K, Weitzendorfer M. [Planning and Design of a Prospective Randomised Multi-Centre Trial on the Repair of Large Hiatal Hernias with Sutures vs. Pledgeted Sutures vs. Absorbable Mesh]. Zentralbl Chir. 2021 Apr;146(2):204-209. doi: 10.1055/a-1369-9694. Epub 2021 Feb 10. German.
    Results Reference
    derived

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    A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

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