K44.0
Conditions
Interventions
Group 1: Data are retrospectively collected at four observation points:
1. preoperative without proton pump inhibitor (PPI) treatment (T0Med-),
2. preoperative with optimized PPI treatment (T0Med+),
Sponsors
Praxis
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusive criteria for all patients from 1/2007-12/2016: 1. substantial impairment of daily life caused by symptoms of hiatal instability regardless of size (giant hernia) or preceded fundoplication, age =15 years; 2. increasing A, B, C, or D symptoms; 3. cardia insufficiency, hiatal hernia, total organ dislocation, esophagitis with Savary Miller grade = 2 or Los-Angeles classification grade = B on endoscopy; 4. histopathologic findings of reflux esophagitis, ulceration, Barrett metaplasia, or dysplasia; 5. insufficient proton pump inhibitor (PPI) medication or adverse effects; and 6. availability of pathologic findings of pH measurement, manometry, X-ray contrast swallow, computed tomography (CT), or magnetic resonance imaging (MRI). The indication for surgery was based on criteria 1 and 2 (mandatory) and at least one or more additional criteria. Patient’s physical status was classified by the physical status classification system of the American Society of Anesthesiologists (ASA).
Exclusion criteria
Exclusion criteria: Exclusion criteria were: age <15 years, suspicion of achalasia or malignancy, comorbidity that did not justify operative treatment, and doubts in diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary aim is to evaluate the effect of the laparoscopic oesophago-hiatal DeltaMesh enhancement in symptomatic hiatal hernia patients on Quality of Life and improvement of symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary aim is to analyze kind and frequency of postoperative complications and the number of hiatal hernia recurrency. | — |
Countries
Germany
Contacts
Public ContactEckhard Löhde
Praxis
Outcome results
None listed