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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

ConditionHiatal Hernia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParacelsus Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)

Written informed consent

≥ 18 years of age

> 5cm hiatal hernia

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Sutures onlyActive comparator 1 intervention
Group B: Absorbable MeshActive comparator 1 intervention
Group C: Pledgeted suturesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hiatal hernia recurrence rate

Hiatal hernia recurrence rate documented by gastroscopy

Time frame
6 months, 1 year, 3 years and 5 years after surgery

Secondary outcomes

1

Quality of Life evaluated by questionnaire

Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)

Time frame
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
2

Symptoms related to Gastroesophageal Reflux Disease (GERD)

Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.

Time frame
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
3

Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)

Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale

Time frame
Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
4

Postoperative complications

Short - term and long - term complications after treatment

Time frame
6 months, 1 year, 3 years and 5 years after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paracelsus Medical University

Lead sponsor

Medical University Innsbruck

Collaborator

Medical University of Vienna

Collaborator

Krankenhaus Barmherzige Schwestern Linz

Collaborator

Elisabethinen Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: