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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| Medical University of Vienna | OTHER |
| Krankenhaus Barmherzige Schwestern Linz | OTHER |
| Elisabethinen Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sutures only | Active Comparator | 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. |
|
| Absorbable Mesh | Active Comparator | 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. |
|
| Pledgeted sutures | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Weitzendorfer, MD, PhD | Contact | +435725551078 | m.weitzendorfer@salk.at | |
| Oliver O Koch, MD, FEBS | Contact | +435725551091 | o.koch@salk.at |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33567462 | Derived | 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. |
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| OTHER |
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.
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|
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 |
| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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