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Completed

NCT Number: NCT02206828

The SymCHro - 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).

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Key information

Conditions

Ventral Incisional Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Club Hernie association represented by Dr Gillion, in his capacity as President

Montrouge, 92120, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain Assessment Measured With VAS Score

    Time frame: 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

  2. Quality of Life for Patient

    Time frame: 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.

  3. Patient Satisfaction

    Time frame: 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.

  4. Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)

    Time frame: Day 0 Baseline

    Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia

  5. Mesh Handling

    Time frame: 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..

  6. The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair

    Time frame: Baseline Day 0

    Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh

  7. The Use of Symbotex™ Composite Mesh and Surgery Duration

    Time frame: Baseline Day 0

    Operative Time (min) for patients treated for ventral hernia

  8. The Use of Symbotex™ Composite Mesh and Hospital Stay Duration

    Time frame: Baseline Day 0

    Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: SymCHro

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2014
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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