Abdominal Hernia, Abdominal Wall Defect, Fascial Hernia, Ventral Hernia
Conditions
Keywords
Reinforcement of Soft Tissues, Hernioplasty, mesh repair
Brief summary
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
Detailed description
The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020
Interventions
DEVICEHernioplasty
Hernioplasty is the repair of the defect using mesh patches.
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia rate | at one follow-up 12-30 months after initial intervention | Rate of hernias occuring during follow-up of retrospectively included patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative complications | intraoperatively | Retrospective documentation of Number of Participants with intraoperative Complications |
| Post-operative complications | at one follow-up 12-30 months after initial intervention | Number of retrospectively included participants having complications during follow-up of |
| Reintervention rate | at one follow-up 12-30 months after initial intervention | Complications leading to reintervention during follow-up of retrospectively included patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic data of the patient: sex | preoperatively | Retrospective documentation of Demographic data of the patient for descriptive purposes: sex |
| Demographic data of the patient: weight | preoperatively | Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index |
| Demographic data of the patient: height | preoperatively | Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index |
| Demographic data of the patient: general health status | preoperatively | Retrospective documentation of Demographic data of the patient for descriptive purposes: general health status according to ASA classification (ASA I: healthy patient; ASA II: A patient with mild systemic disease; ASA III: A patient with severe systemic disease; ASA IV: A patient with severe systemic disease that is a constant threat to life; ASA V: A moribund patient who is not expected to survive without the operation) |
| Surgery details: duration of surgery | intraoperative | Retrospective documentation of surgery details for descriptive purposes: duration of surgery |
| Surgery details: Type of intervention | intraoperative | Retrospective documentation of surgery details for descriptive purposes: Type of intervention (elective / emergency) |
| Surgery details: access | intraoperative | Retrospective documentation of surgery details for descriptive purposes: access (open / laparoscopic / laparoscopic with conversion) |
| Surgery details: anesthetics | intraoperative | Retrospective documentation of surgery details for descriptive purposes: anesthetics (general / regional / local) |
| Demographic data of the patient: risk factors | preoperatively | Retrospective documentation of Demographic data of the patient for descriptive purposes: risk factors (smoker, alcohol abuse, previous surgery of abdominal hernia, chronic immunosuppression, chronic cortison treatment, abdominal aortic aneurysm, anticoagulantic treatment) |
| Surgery details: details on implanted mesh | intraoperative | Retrospective documentation of surgery details for descriptive purposes: details on implanted mesh (number / sizes) |
| Surgery details: closure technology | intraoperative | Retrospective documentation of surgery details for descriptive purposes: closure technology (absorbable suture, non absorbable suture, single-knot, continuous suture, adhesives) |
| Demographic data of the patient: age | preoperatively | Retrospective documentation of Demographic data of the patient for descriptive purposes: age of patients at time of surgery |
Countries
Spain
Outcome results
None listed