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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

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date April 2, 2024
Estimated Study Start Date  ICMJE May 1, 2024
Estimated Primary Completion Date May 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)		 Hiatal hernia recurrence rate [ Time Frame: 6 months, 1 year, 3 years and 5 years after surgery ]
Hiatal hernia recurrence rate documented by gastroscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • 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)
  • 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.
  • 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
  • Postoperative complications [ Time Frame: 6 months, 1 year, 3 years and 5 years after surgery ]
    Short - term and long - term complications after treatment
  • Length of hospital stay [ Time Frame: up to 90 days ]
    Length of hospital stay and mortality rates
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
Official Title  ICMJE A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Hiatal Hernia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

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

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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2020)		 165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2027
Estimated Primary Completion Date May 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Weitzendorfer, MD, PhD +435725551078 m.weitzendorfer@salk.at
Contact: Oliver O Koch, MD, FEBS +435725551091 o.koch@salk.at
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04591860
Other Study ID Numbers  ICMJE Phasix™ST - Austria
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Michael Weitzendorfer, MD, Paracelsus Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Paracelsus Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Medical University Innsbruck
  • Medical University of Vienna
  • Krankenhaus Barmherzige Schwestern Linz
  • Elisabethinen Hospital
Investigators  ICMJE Not Provided
PRS Account Paracelsus Medical University
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP