Abdominal Hernia
Conditions
Keywords
Abdominal Hernia, Ventral Hernia, Atraumatic mesh
Brief summary
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate
Detailed description
The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique. All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surg ery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen. All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen. The latest follow up should be completed by 31.03.2022. For both, the retro- and prospective arm, the time needed for the follow-up appointment is approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the questionnaires is estimated to take 20-30 minutes.
Interventions
DIAGNOSTIC_TESTSelective Sonography of the ventral abdominal hernia level
The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)
Sponsors
Spital Limmattal Schlieren
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
retro- and prospective arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 18 years * Initially suffering from ventral abdominal hernia * Performance of open ventral abdominal hernia repair with self-adhering, atraumatic mesh (Adhesix ®) * Informed Consent as documented by signature (Appendix: Informed Consent Form)
Exclusion criteria
* Inability to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrance rate in sonography | 12 months after surgery | The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination and sonography. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers . |
| Recurrance rate clinically | 12 months after surgery | The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire | 12 months after surgery | Clinical subjective outcome 1 |
| Limitations in quality of life questionnaire | 12 months after surgery | Clinical subjective outcome 2 |
| Daily activities measured HerQLes questionnaire | 12 months after surgery | Clinical subjective outcome 3 |
Countries
Switzerland
Outcome results
None listed