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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hiatal Hernia

Intervention / Treatment
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* Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sutures only<br>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<br>* 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.<br>|
| Active Comparator: Absorbable Mesh<br>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<br>* 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.<br>|
| Active Comparator: Pledgeted sutures<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hiatal hernia recurrence rate | 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 | 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) | 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) | 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 | Short - term and long - term complications after treatment | 6 months, 1 year, 3 years and 5 years after surgery | 
| Length of hospital stay | Length of hospital stay and mortality rates | up to 90 days | 
| Predictive parameters for treatment response or failure I | 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 | Height (in meters) | Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hiatal hernia, pledgets, mesh, hernia recurrence