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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2022
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Hernioplasty
Hernioplasty is the repair of the defect using mesh patches.

Locations

Country Name City State
Spain Hospital Galdakao-Usansolo Galdakao Bizkaia
Spain Hospital Universitario de Salamanca Salamanca

Sponsors (2)

Lead Sponsor Collaborator
Aesculap AG B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

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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