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NCT Number: NCT04591860

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

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.

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Key information

Conditions

Hiatal Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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 outcomes

  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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Weitzendorfer, MD, PhD

CONTACT

[email protected]

+435725551078

Oliver O Koch, MD, FEBS

CONTACT

[email protected]

+435725551091

Sponsors and collaborators

Lead sponsor

Paracelsus Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2020
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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