Hiatal Hernia
Conditions
Keywords
hiatal hernia, pledgets, mesh, hernia recurrence
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.
Interventions
DEVICELaparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
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.
Sponsors
Medical University Innsbruck
Medical University of Vienna
Krankenhaus Barmherzige Schwestern Linz
Elisabethinen Hospital
Paracelsus Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hiatal hernia recurrence rate | 6 months, 1 year, 3 years and 5 years after surgery | Hiatal hernia recurrence rate documented by gastroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms related to Gastroesophageal Reflux Disease (GERD) | Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery | Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale. |
| Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD) | Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery | Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale |
| Postoperative complications | 6 months, 1 year, 3 years and 5 years after surgery | Short - term and long - term complications after treatment |
| Quality of Life evaluated by questionnaire | Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery | Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI) |
| Predictive parameters for treatment response or failure I | Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery | Weight (in kilograms) |
| Predictive parameters for treatment response or failure II | Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery | Height (in meters) |
| Length of hospital stay | up to 90 days | Length of hospital stay and mortality rates |
Contacts
Primary ContactMichael Weitzendorfer, MD, PhD
Backup ContactOliver O Koch, MD, FEBS
Outcome results
None listed