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

Sponsor

Paracelsus Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04591860

Collaborator

Medical University Innsbruck (Other), Medical University of Vienna (Other), Krankenhaus Barmherzige Schwestern Linz (Other), Elisabethinen Hospital (Other)

165

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable 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.

Condition or Disease	Intervention/Treatment	Phase
Hiatal Hernia	Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

165 participants

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.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

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

Hiatal hernia recurrence rate [6 months, 1 year, 3 years and 5 years after surgery]
Hiatal hernia recurrence rate documented by gastroscopy

Secondary Outcome Measures

Quality of Life evaluated by questionnaire [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) [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) [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 [6 months, 1 year, 3 years and 5 years after surgery]
Short - term and long - term complications after treatment
Length of hospital stay [up to 90 days]
Length of hospital stay and mortality rates
Predictive parameters for treatment response or failure I [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 [Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery]
Height (in meters)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Weitzendorfer, MD, Dr. Michael Weitzendorfer, PhD, Paracelsus Medical University

ClinicalTrials.gov Identifier:

NCT04591860

Other Study ID Numbers:

Phasix™ST - Austria

First Posted:

Oct 19, 2020

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Weitzendorfer, MD, Dr. Michael Weitzendorfer, PhD, Paracelsus Medical University

Additional relevant MeSH terms:

Hernia

Hernia, Hiatal

Study Results

No Results Posted as of Apr 20, 2022