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Not yet recruiting NCT04591860

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

No phase Interventional Hiatal Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet.
Who it may be relevant to
Registry conditions: Hiatal Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Hiatal hernia recurrence rate [Time frame: 6 months, 1 year, 3 years and 5 years after surgery]
Secondary outcome measures (7)
  • Quality of Life evaluated by questionnaire [Time frame: 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]
  • 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]
  • Postoperative complications [Time frame: 6 months, 1 year, 3 years and 5 years after surgery]
  • Length of hospital stay [Time frame: 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]
  • Predictive parameters for treatment response or failure II [Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 33567462

Identifiers

NCT: NCT04591860 · Phasix™ST - Austria

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗