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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 GROUP | Only 1 group not predetermined |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Peri-operative and Post-operative Complications | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment Measured With VAS Score | 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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Inclusion Criteria:
Exclusion Criteria:
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adult patients scheduled for primary and incisional abdominal wall hernia surgeries
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François Gillion | ICMJE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Club Hernie association represented by Dr Gillion, in his capacity as President | Montrouge | 92120 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbotex Composite Mesh | Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
100 patients exhibited ventral hernia
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbotex Composite Mesh | Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Peri-operative and Post-operative Complications | 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 | 6 patients are lost to follow up at 1 year - 7 patients are lost to follow up at 2 year , it is described in the Participant Flow module Outcomes measure reflect Patients who completed each visits | Posted | Count of Participants | Participants | Various (measured at 1 month, 1 Year & 2 Year) |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symbotex Composite Mesh | Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Djamila Bennat | Medtronic | 33474089000 | 1591 | djamila.bennat@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2014 | Sep 4, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2015 | Sep 4, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Quality of Life for Patient | 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. | Various ( 1 Month, 1 year and 2 Year follow up) |
| Patient Satisfaction | 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. | Various (1 year and 2 year) |
| Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia | Day 0 Baseline |
| Mesh Handling | 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.. | Day 0 Baseline |
| The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair | Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh | Baseline Day 0 |
| The Use of Symbotex™ Composite Mesh and Surgery Duration | Operative Time (min) for patients treated for ventral hernia | Baseline Day 0 |
| The Use of Symbotex™ Composite Mesh and Hospital Stay Duration | Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device | Baseline Day 0 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Recurrence Rate at 1 Year |
Recurrence rate following patients treated for ventral hernia |
| OG002 | Recurrence Rate at 2 Year | Recurrence rate following patients treated for ventral hernia |
|
|
| Secondary | Pain Assessment Measured With VAS Score | 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 | Posted | Mean | Standard Deviation | units on a scale | Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year |
|
|
|
| Secondary | Quality of Life for Patient | 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. | Posted | Count of Participants | Participants | Various ( 1 Month, 1 year and 2 Year follow up) |
|
|
|
| Secondary | Patient Satisfaction | 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. | Posted | Count of Participants | Participants | Various (1 year and 2 year) |
|
|
|
| Secondary | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia | Number of Hernia, some patients exhibits more than 1 hernia (100 patients with 105 ventral hernias) Ease of use: results is based on 100 patients and 105 hernias (100 patients enrolled and having 105 hernias) , However results reported of subjects with missing data or not applicable data respectively; | Posted | Count of Units | Hernia | Day 0 Baseline | Hernia | Hernia |
|
|
|
| Secondary | Mesh Handling | 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.. | Posted | Number | participants | Day 0 Baseline |
|
|
|
| Secondary | The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair | Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh | Posted | Count of Participants | Participants | Baseline Day 0 |
|
|
|
| Secondary | The Use of Symbotex™ Composite Mesh and Surgery Duration | Operative Time (min) for patients treated for ventral hernia | 3 approaches of surgery , thus operative time and hospital stay are provided according to the nature of the surgery the unit of Operative time is in minutes (specify in the title see below) And the unit of hospital stay is in days (speify in the title see below) Missing data on 4 patients. | Posted | Mean | Standard Deviation | minutes | Baseline Day 0 |
|
|
|
| Secondary | The Use of Symbotex™ Composite Mesh and Hospital Stay Duration | Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device | For 8 patients there is 8 missing data respectively | Posted | Mean | Standard Deviation | days | Baseline Day 0 |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 9 |
| 100 |
| Transitory ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Not assessed |
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| Do you feel a lump? |
|
| Do you feel any pain or discomfort? |
|
| Reoperation needed? |
|
| Medium |
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| Bad |
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| Hernia |
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| Unsatisfying |
|
| Title | Measurements |
|---|---|
|
| Prothesis Shape memory eases to place |
|
| Mesh transparency eases to place |
|
| Mesh easy to re-place |
|
| The mesh does not twist during stapling |
|
|
| Open then Laparoscopy |
|
|
| Title | Measurements |
|---|---|
|