Clinical Study on the Safety of SAFIL® MESH

Ventral Hernia Clinical Trial

— SAFIL_MESH  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947202
• Other study ID #: AAG-O-H-2040
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Abdominal Hernia
• Abdominal Wall Defect
• Fascial Hernia
• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia
• Ventral Hernia

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