The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
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Details and patient eligibility
About
The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).
Full description
This is an observational multicenter registry study. One hundred consecutive, adult patients scheduled for primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh will be reported in the ClubHernie online database, with standard data captured of all preoperative, perioperative and post-operative data, for patient's outcomes measurements.
Primary Objective:
Evaluate the incidence of peri-operative and post-operative complications, with postoperative evaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month (D30 follow up), 1 year and 2 year follow up after primary and incisional abdominal wall hernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach (such as anticipated device related complications such as pain, recurrence, complications related to adhesions, wound complications, other postoperative complications, (SAE).
This online database consists of a systematic and consecutive data entry of all patients treated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, with standard data captured of all preoperative, perioperative and post-operative data.
The database is required to be completed anonymously. Quality data control of all data captured into the online database will be performed by coherence analysis by Club Hernie authorized representative;A statistical analysis plan will be developed by Covidien.
Study reported device-related events will be reviewed periodically to assess for any potential trends
Enrollment
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Volunteers
Inclusion criteria
- The first one hundred consecutive adult patients scheduled for primary and incisional abdominal wall hernia surgery by Club Hernie members surgeons using Symbotex™Composite Mesh ;- All patients regardless of gender ≥ 18 years of age presenting with ventral hernias.
- Patients will be informed by surgeon with a written information notice of the nature of the observational registry study.
Exclusion criteria
- No exclusion criteria outside the product IFU
Trial design
100 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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