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

April 1, 2024 updated by: Michael Weitzendorfer, MD, Paracelsus Medical University

A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Oliver O Koch, MD, FEBS
  • Phone Number: +435725551091
  • Email: o.koch@salk.at

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hiatal hernia recurrence rate
Time Frame: 6 months, 1 year, 3 years and 5 years after surgery
Hiatal hernia recurrence rate documented by gastroscopy
6 months, 1 year, 3 years and 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
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.
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
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
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Postoperative complications
Time Frame: 6 months, 1 year, 3 years and 5 years after surgery
Short - term and long - term complications after treatment
6 months, 1 year, 3 years and 5 years after surgery
Length of hospital stay
Time Frame: up to 90 days
Length of hospital stay and mortality rates
up to 90 days
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)
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
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)
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Medical University

Collaborators

Medical University of Vienna
Medical University Innsbruck
Krankenhaus Barmherzige Schwestern Linz
Elisabethinen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phasix™ST - Austria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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