Ventral Incisional HerniaSymCHroNCT02206828
The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
An observational study of Ventral Incisional Hernia, run by Medtronic - MITG at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Incisional Hernia
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2014to 22 May 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients scheduled for primary and incisional abdominal wall hernia surgeries
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria outside the product IFU
Trial locations and contacts
1 site in 1 country.
France1 site
Club Hernie association represented by Dr Gillion, in his capacity as President
Montrouge, 92120
About this study
Official title: Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
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).
Read the 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
- Conditions
- Ventral Incisional Hernia
- Keywords
- HERNIA, SYMCHRO, SOFRADIM, REGISTRY, SYMBOTEX
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 GROUP | Only 1 group not predetermined |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Various (measured at 1 month, 1 Year & 2 Year)
Secondary outcomes (8)
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
Measured: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
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.
Measured: 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.
Measured: 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
Measured: 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..
Measured: 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
Measured: Baseline Day 0
The Use of Symbotex™ Composite Mesh and Surgery Duration
Operative Time (min) for patients treated for ventral hernia
Measured: 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
Measured: Baseline Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study start25 Jun 2014
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-François Gillion, Principal investigator, ICMJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206828
- Sponsor's protocol ID
- COVSYMB0441
- Acronym
- SymCHro
- Status last verified
- Dec 2024
- First submitted
- 21 Jul 2014
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02206828
- Acronym / sponsor ID
- SymCHro / COVSYMB0441
- Conditions
- Ventral Incisional Hernia
- Keywords
- HERNIA, SYMCHRO, SOFRADIM, REGISTRY, SYMBOTEX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 GROUP | – | –Only 1 group not predetermined |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients scheduled for primary and incisional abdominal wall hernia surgeries
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria outside the product IFU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Peri-operative and Post-operative Complications
Time frame: 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
8 secondary outcomes
Pain Assessment Measured With VAS Score
Time frame: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
Quality of Life for Patient
Time frame: Various ( 1 Month, 1 year and 2 Year follow up)
Patient Satisfaction
Time frame: Various (1 year and 2 year)
Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)
Time frame: Day 0 Baseline
Mesh Handling
Time frame: Day 0 Baseline
The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
Time frame: Baseline Day 0
The Use of Symbotex™ Composite Mesh and Surgery Duration
Time frame: Baseline Day 0
The Use of Symbotex™ Composite Mesh and Hospital Stay Duration
Time frame: Baseline Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Gillion principal investigator
ICMJE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Incisional Hernia, run by Medtronic - MITG at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Peri-operative and Post-operative Complications (time frame: Various (measured at 1 month, 1 Year & 2 Year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.