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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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ClinicalTrials.gov Identifier: NCT04591860
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : April 2, 2024
Sponsor:
Collaborators:
Medical University Innsbruck
Medical University of Vienna
Krankenhaus Barmherzige Schwestern Linz
Elisabethinen Hospital
Information provided by (Responsible Party):
Michael Weitzendorfer, MD, Paracelsus Medical University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hiatal Hernia Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : May 1, 2027
Estimated Study Completion Date : May 1, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sutures only

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.

 Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
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.
Active Comparator: Absorbable Mesh

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.

 Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
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.
Active Comparator: Pledgeted sutures

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.

 Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hiatal hernia recurrence rate [ Time Frame: 6 months, 1 year, 3 years and 5 years after surgery ]
    Hiatal hernia recurrence rate documented by gastroscopy


Secondary Outcome Measures :
  1. Quality of Life evaluated by questionnaire [ Time Frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery ]
    Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)

  2. Symptoms related to Gastroesophageal Reflux Disease (GERD) [ Time Frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery ]
    Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.

  3. Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD) [ Time Frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery ]
    Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale

  4. Postoperative complications [ Time Frame: 6 months, 1 year, 3 years and 5 years after surgery ]
    Short - term and long - term complications after treatment

  5. Length of hospital stay [ Time Frame: up to 90 days ]
    Length of hospital stay and mortality rates

  6. Predictive parameters for treatment response or failure I [ Time Frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery ]
    Weight (in kilograms)

  7. Predictive parameters for treatment response or failure II [ Time Frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery ]
    Height (in meters)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04591860


Contacts
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Contact: Michael Weitzendorfer, MD, PhD +435725551078 m.weitzendorfer@salk.at
Contact: Oliver O Koch, MD, FEBS +435725551091 o.koch@salk.at

Sponsors and Collaborators
Paracelsus Medical University
Medical University Innsbruck
Medical University of Vienna
Krankenhaus Barmherzige Schwestern Linz
Elisabethinen Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Weitzendorfer, MD, Dr. Michael Weitzendorfer, PhD, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT04591860    
Other Study ID Numbers: Phasix™ST - Austria
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Weitzendorfer, MD, Paracelsus Medical University:
hiatal hernia
pledgets
mesh
hernia recurrence
Additional relevant MeSH terms:
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Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic
Internal Hernia