Ventral Incisional Hernia
Conditions
Keywords
HERNIA, SYMCHRO, SOFRADIM, REGISTRY, SYMBOTEX
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
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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.. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symbotex Composite Mesh Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Symbotex Composite Mesh | — |
|---|---|---|
| Age, Continuous | 62.0 Years STANDARD_DEVIATION 13.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 100 participants | — |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 49 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 9 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
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
Time frame: Various (measured at 1 month, 1 Year & 2 Year)
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recurence Rate at 1 Month | Incidence of Peri-operative and Post-operative Complications | 0 Participants |
| Recurrence Rate at 1 Year | Incidence of Peri-operative and Post-operative Complications | 1 Participants |
| Recurrence Rate at 2 Year | Incidence of Peri-operative and Post-operative Complications | 0 Participants |
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..
Time frame: Day 0 Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Recurence Rate at 1 Month | Mesh Handling | Marking eases to place | 68 participants |
| Recurence Rate at 1 Month | Mesh Handling | conformability to the anatomy is useful | 34 participants |
| Recurence Rate at 1 Month | Mesh Handling | Absence of direction for positioning is useful | 32 participants |
| Recurence Rate at 1 Month | Mesh Handling | Prothesis Shape memory eases to place | 53 participants |
| Recurence Rate at 1 Month | Mesh Handling | Mesh transparency eases to place | 74 participants |
| Recurence Rate at 1 Month | Mesh Handling | Mesh easy to re-place | 51 participants |
| Recurence Rate at 1 Month | Mesh Handling | The mesh does not twist during stapling | 43 participants |
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
Time frame: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recurence Rate at 1 Month | Pain Assessment Measured With VAS Score | 4.7 units on a scale | Standard Deviation 2.5 |
| Recurrence Rate at 1 Year | Pain Assessment Measured With VAS Score | 3.9 units on a scale | Standard Deviation 1.8 |
| Recurrence Rate at 2 Year | Pain Assessment Measured With VAS Score | 2.0 units on a scale | Standard Deviation 1.7 |
| VAS Pain Assessment Month 1 | Pain Assessment Measured With VAS Score | 0.8 units on a scale | Standard Deviation 1.8 |
| VAS Pain Assessment Month 3 | Pain Assessment Measured With VAS Score | 0.2 units on a scale | Standard Deviation 0.7 |
| VAS Pain Assessment 1 Year | Pain Assessment Measured With VAS Score | 0.0 units on a scale | Standard Deviation 0 |
| VAS Pain Assessment 2 Year | Pain Assessment Measured With VAS Score | 0.0 units on a scale | Standard Deviation 0 |
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.
Time frame: Various (1 year and 2 year)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recurence Rate at 1 Month | Patient Satisfaction | Excellent | 10 Participants |
| Recurence Rate at 1 Month | Patient Satisfaction | Good | 73 Participants |
| Recurence Rate at 1 Month | Patient Satisfaction | Medium | 7 Participants |
| Recurence Rate at 1 Month | Patient Satisfaction | Bad | 4 Participants |
| Recurrence Rate at 1 Year | Patient Satisfaction | Bad | 2 Participants |
| Recurrence Rate at 1 Year | Patient Satisfaction | Excellent | 7 Participants |
| Recurrence Rate at 1 Year | Patient Satisfaction | Medium | 3 Participants |
| Recurrence Rate at 1 Year | Patient Satisfaction | Good | 79 Participants |
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.
Time frame: Various ( 1 Month, 1 year and 2 Year follow up)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Recurence Rate at 1 Month | Quality of Life for Patient | Does the abdominal wall seem firm? | Yes | 0 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Does the abdominal wall seem firm? | No | 0 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Does the abdominal wall seem firm? | Not assessed | 82 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Do you feel a lump? | Yes | 0 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Do you feel a lump? | No | 0 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Do you feel a lump? | Not assessed | 82 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Do you feel any pain or discomfort? | Yes | 20 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Do you feel any pain or discomfort? | No | 62 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Do you feel any pain or discomfort? | Not assessed | 0 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Reoperation needed? | Yes | 0 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Reoperation needed? | No | 82 Participants |
| Recurence Rate at 1 Month | Quality of Life for Patient | Reoperation needed? | Not assessed | 0 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Reoperation needed? | Not assessed | 0 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Does the abdominal wall seem firm? | Yes | 90 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Do you feel any pain or discomfort? | Yes | 23 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Do you feel any pain or discomfort? | Not assessed | 0 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Does the abdominal wall seem firm? | No | 4 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Do you feel a lump? | Not assessed | 0 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Reoperation needed? | No | 94 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Does the abdominal wall seem firm? | Not assessed | 0 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Do you feel any pain or discomfort? | No | 71 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Do you feel a lump? | No | 87 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Do you feel a lump? | Yes | 7 Participants |
| Recurrence Rate at 1 Year | Quality of Life for Patient | Reoperation needed? | Yes | 0 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Do you feel a lump? | Yes | 2 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Do you feel a lump? | No | 91 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Reoperation needed? | Yes | 1 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Do you feel a lump? | Not assessed | 0 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Do you feel any pain or discomfort? | Yes | 12 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Do you feel any pain or discomfort? | No | 81 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Reoperation needed? | No | 92 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Does the abdominal wall seem firm? | Yes | 91 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Does the abdominal wall seem firm? | No | 2 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Do you feel any pain or discomfort? | Not assessed | 0 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Does the abdominal wall seem firm? | Not assessed | 0 Participants |
| Recurrence Rate at 2 Year | Quality of Life for Patient | Reoperation needed? | Not assessed | 0 Participants |
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
Time frame: Day 0 Baseline
Population: 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;
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Recurence Rate at 1 Month | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Unsatisfying | 0 Hernia |
| Recurence Rate at 1 Month | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Satisfying | 102 Hernia |
| Recurrence Rate at 1 Year | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Satisfying | 80 Hernia |
| Recurrence Rate at 1 Year | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Unsatisfying | 0 Hernia |
| Recurrence Rate at 2 Year | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Unsatisfying | 0 Hernia |
| Recurrence Rate at 2 Year | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Satisfying | 102 Hernia |
| VAS Pain Assessment Month 1 | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Satisfying | 94 Hernia |
| VAS Pain Assessment Month 1 | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Unsatisfying | 2 Hernia |
| VAS Pain Assessment Month 3 | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Unsatisfying | 0 Hernia |
| VAS Pain Assessment Month 3 | Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) | Satisfying | 92 Hernia |
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
Time frame: Baseline Day 0
Population: For 8 patients there is 8 missing data respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh and Hospital Stay Duration | Open (Laparotomy) | 4.7 days | Standard Deviation 2 |
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh and Hospital Stay Duration | Laparoscopy | 1.6 days | Standard Deviation 1.6 |
Secondary
The Use of Symbotex™ Composite Mesh and Surgery Duration
Operative Time (min) for patients treated for ventral hernia
Time frame: Baseline Day 0
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh and Surgery Duration | Open (Laparotomy) | 67.4 minutes | Standard Deviation 25.8 |
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh and Surgery Duration | Laparoscopy | 36.2 minutes | Standard Deviation 23.5 |
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh and Surgery Duration | Open then Laparoscopy | 68.3 minutes | Standard Deviation 32.1 |
Secondary
The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh
Time frame: Baseline Day 0
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair | Open (Laparotomy) | 20 Participants |
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair | Laparoscopy | 77 Participants |
| Recurence Rate at 1 Month | The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair | Open then Laparoscopy | 3 Participants |