The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair

Completed

Conditions: Ventral Incisional Hernia

Registration Number: NCT02206828

Lead Sponsor: Medtronic - MITG

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Peri-operative and Post-operative Complications	Various (measured at 1 month, 1 Year & 2 Year)	Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair. All peri-, intra- and post- operative complications

Secondary Outcome Measures

Name	Time	Method
The Use of Symbotex™ Composite Mesh and Surgery Duration	Baseline Day 0	Operative Time (min) for patients treated for ventral hernia
The Use of Symbotex™ Composite Mesh and Hospital Stay Duration	Baseline Day 0	Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device
Quality of Life for Patient	Various ( 1 Month, 1 year and 2 Year follow up)	Quality of Life of patients treated for ventral hernia For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.
Patient Satisfaction	Various (1 year and 2 year)	Patient satisfaction For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.
Pain Assessment Measured With VAS Score	Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year	Pain assessment measured with VAS\* score \*VAS: The postoperative pain is assessed using a 0-10 Visual Analogue Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3; Moderate pain for VAS score \> 3 and \> 6 ; Severe pain for VAS scores \> 6
Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)	Day 0 Baseline	Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia
Mesh Handling	Day 0 Baseline	ease of use / mesh Handling Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia- Participant reflect surgeon who asses the feature of the mesh (for example, 68 surgeons agree that marking eases to place the mesh, 34 surgeons agree that the mesh is conformable to the anatomy etc..
The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair	Baseline Day 0	Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh