- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02206828
The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair (SymCHro)
Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montrouge, France, 92120
- Club Hernie association represented by Dr Gillion, in his capacity as President
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1 GROUP
Only 1 group not predetermined
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Peri-operative and Post-operative Complications
Time Frame: Various (measured at 1 month, 1 Year & 2 Year)
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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 |
Various (measured at 1 month, 1 Year & 2 Year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment Measured With VAS Score
Time Frame: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
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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 |
Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
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Quality of Life for Patient
Time Frame: Various ( 1 Month, 1 year and 2 Year follow up)
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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.
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Various ( 1 Month, 1 year and 2 Year follow up)
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Patient Satisfaction
Time Frame: Various (1 year and 2 year)
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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.
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Various (1 year and 2 year)
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Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)
Time Frame: Day 0 Baseline
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Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia
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Day 0 Baseline
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Mesh Handling
Time Frame: Day 0 Baseline
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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..
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Day 0 Baseline
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The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
Time Frame: Baseline Day 0
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Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh
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Baseline Day 0
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The Use of Symbotex™ Composite Mesh and Surgery Duration
Time Frame: Baseline Day 0
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Operative Time (min) for patients treated for ventral hernia
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Baseline Day 0
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The Use of Symbotex™ Composite Mesh and Hospital Stay Duration
Time Frame: Baseline Day 0
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Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device
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Baseline Day 0
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-François Gillion, ICMJE
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVSYMB0441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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