An observational study in Abdominal Wall Defect, Ventral Hernia and Abdominal Hernia, sponsored by Aesculap AG. Completed at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by Aesculap AG (part of B. Braun) · Observational
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
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
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's enrollment of 152 is above the median of 132 across 65 observational studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Hernioplasty
Hernioplasty is the repair of the defect using mesh patches.
Hernia rate
Rate of hernias occuring during follow-up of retrospectively included patients
Time frame: at one follow-up 12-30 months after initial intervention
Intra-operative complications
Retrospective documentation of Number of Participants with intraoperative Complications
Time frame: intraoperatively
Post-operative complications
Number of retrospectively included participants having complications during follow-up of
Time frame: at one follow-up 12-30 months after initial intervention
Reintervention rate
Complications leading to reintervention during follow-up of retrospectively included patients
Time frame: at one follow-up 12-30 months after initial intervention
Demographic data of the patient: age
Retrospective documentation of Demographic data of the patient for descriptive purposes: age of patients at time of surgery
Time frame: preoperatively
Demographic data of the patient: sex
Retrospective documentation of Demographic data of the patient for descriptive purposes: sex
Time frame: preoperatively
Demographic data of the patient: weight
Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index
Time frame: preoperatively
Demographic data of the patient: height
Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index
Time frame: preoperatively
Demographic data of the patient: general health status
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)
Time frame: preoperatively
Demographic data of the patient: risk factors
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)
Time frame: preoperatively
Surgery details: Type of intervention
Retrospective documentation of surgery details for descriptive purposes: Type of intervention (elective / emergency)
Time frame: intraoperative
Surgery details: access
Retrospective documentation of surgery details for descriptive purposes: access (open / laparoscopic / laparoscopic with conversion)
Time frame: intraoperative
Surgery details: anesthetics
Retrospective documentation of surgery details for descriptive purposes: anesthetics (general / regional / local)
Time frame: intraoperative
Surgery details: duration of surgery
Retrospective documentation of surgery details for descriptive purposes: duration of surgery
Time frame: intraoperative
Surgery details: details on implanted mesh
Retrospective documentation of surgery details for descriptive purposes: details on implanted mesh (number / sizes)
Time frame: intraoperative
Surgery details: closure technology
Retrospective documentation of surgery details for descriptive purposes: closure technology (absorbable suture, non absorbable suture, single-knot, continuous suture, adhesives)
Time frame: intraoperative
Ran from Jul 2021 to primary completion in Nov 2021, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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