Hiatal Hernia Clinical Trial
Official title:
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
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.
Status | Not yet recruiting |
Enrollment | 165 |
Est. completion date | May 1, 2027 |
Est. primary completion date | May 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Paracelsus Medical University | Elisabethinen Hospital, Krankenhaus Barmherzige Schwestern Linz, Medical University Innsbruck, Medical University of Vienna |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hiatal hernia recurrence rate | Hiatal hernia recurrence rate documented by gastroscopy | 6 months, 1 year, 3 years and 5 years after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Postoperative complications | Short - term and long - term complications after treatment | 6 months, 1 year, 3 years and 5 years after surgery | |
Secondary | Length of hospital stay | Length of hospital stay and mortality rates | up to 90 days | |
Secondary | 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 | |
Secondary | 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 |
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