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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
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.
Hiatal hernia recurrence rate
Hiatal hernia recurrence rate documented by gastroscopy
Time frame: 6 months, 1 year, 3 years and 5 years after surgery
Quality of Life evaluated by questionnaire
Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)
Time frame: 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.
Time frame: 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
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Postoperative complications
Short - term and long - term complications after treatment
Time frame: 6 months, 1 year, 3 years and 5 years after surgery
Length of hospital stay
Length of hospital stay and mortality rates
Time frame: up to 90 days
Predictive parameters for treatment response or failure I
Weight (in kilograms)
Time frame: 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)
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
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