A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hiatal Hernia
- Sponsor
- Paracelsus Medical University
- Enrollment
- 165
- Primary Endpoint
- Hiatal hernia recurrence rate
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Michael Weitzendorfer, MD
Dr. Michael Weitzendorfer, PhD
Paracelsus Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hiatal hernia recurrence rate
Time Frame: 6 months, 1 year, 3 years and 5 years after surgery
Hiatal hernia recurrence rate documented by gastroscopy
Secondary Outcomes
- Symptoms related to Gastroesophageal Reflux Disease (GERD)(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Postoperative complications(6 months, 1 year, 3 years and 5 years after surgery)
- Predictive parameters for treatment response or failure I(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Quality of Life evaluated by questionnaire(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Length of hospital stay(up to 90 days)
- Predictive parameters for treatment response or failure II(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)