Ventral Hernia Clinical Trial
— SAFIL_MESHOfficial title:
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
NCT number | NCT04947202 |
Other study ID # | AAG-O-H-2040 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | November 30, 2021 |
Verified date | January 2022 |
Source | Aesculap AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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
Status | Completed |
Enrollment | 152 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh Exclusion Criteria: - No exclusion criteria have been set. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Galdakao-Usansolo | Galdakao | Bizkaia |
Spain | Hospital Universitario de Salamanca | Salamanca |
Lead Sponsor | Collaborator |
---|---|
Aesculap AG | B.Braun Surgical SA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic data of the patient: age | Retrospective documentation of Demographic data of the patient for descriptive purposes: age of patients at time of surgery | preoperatively | |
Other | Demographic data of the patient: sex | Retrospective documentation of Demographic data of the patient for descriptive purposes: sex | preoperatively | |
Other | 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 | preoperatively | |
Other | 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 | preoperatively | |
Other | 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) | preoperatively | |
Other | 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) | preoperatively | |
Other | Surgery details: Type of intervention | Retrospective documentation of surgery details for descriptive purposes:
Type of intervention (elective / emergency) |
intraoperative | |
Other | Surgery details: access | Retrospective documentation of surgery details for descriptive purposes:
access (open / laparoscopic / laparoscopic with conversion) |
intraoperative | |
Other | Surgery details: anesthetics | Retrospective documentation of surgery details for descriptive purposes:
anesthetics (general / regional / local) |
intraoperative | |
Other | Surgery details: duration of surgery | Retrospective documentation of surgery details for descriptive purposes:
duration of surgery |
intraoperative | |
Other | Surgery details: details on implanted mesh | Retrospective documentation of surgery details for descriptive purposes:
details on implanted mesh (number / sizes) |
intraoperative | |
Other | Surgery details: closure technology | Retrospective documentation of surgery details for descriptive purposes:
closure technology (absorbable suture, non absorbable suture, single-knot, continuous suture, adhesives) |
intraoperative | |
Primary | Hernia rate | Rate of hernias occuring during follow-up of retrospectively included patients | at one follow-up 12-30 months after initial intervention | |
Secondary | Intra-operative complications | Retrospective documentation of Number of Participants with intraoperative Complications | intraoperatively | |
Secondary | Post-operative complications | Number of retrospectively included participants having complications during follow-up of | at one follow-up 12-30 months after initial intervention | |
Secondary | Reintervention rate | Complications leading to reintervention during follow-up of retrospectively included patients | at one follow-up 12-30 months after initial intervention |
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