Clinical trial NCT02206828: The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Official title: Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Incisional Hernia
Keywords: HERNIA
SYMCHRO
SOFRADIM
REGISTRY
SYMBOTEX
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients scheduled for primary and incisional abdominal wall hernia surgeries

Brief summary: 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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Peri-operative and Post-operative Complications
timeFrame: Various (measured at 1 month, 1 Year & 2 Year)
Secondary outcomes:
measure: Pain Assessment Measured With VAS Score
timeFrame: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
measure: Quality of Life for Patient
timeFrame: Various ( 1 Month, 1 year and 2 Year follow up)
measure: Patient Satisfaction
timeFrame: Various (1 year and 2 year)
measure: Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)
timeFrame: Day 0 Baseline
measure: Mesh Handling
timeFrame: Day 0 Baseline
measure: The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
timeFrame: Baseline Day 0
measure: The Use of Symbotex™ Composite Mesh and Surgery Duration
timeFrame: Baseline Day 0
measure: The Use of Symbotex™ Composite Mesh and Hospital Stay Duration
timeFrame: Baseline Day 0
Other outcomes:
Locations:
city: Montrouge
country: France
facility: Club Hernie association represented by Dr Gillion, in his capacity as President
Study officials:
affiliation: ICMJE
name: Jean-François Gillion
role: PRINCIPAL_INVESTIGATOR
References: