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

Ventral Incisional Hernia Clinical Trial

— SymCHro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206828
• Other study ID #: COVSYMB0441
• Status: Completed
• Start date: June 25, 2014
• Est. completion date: May 22, 2017

Study information

• Verified date: October 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Incisional Hernia

Locations

Country	Name	City	State
France	Club Hernie association represented by Dr Gillion, in his capacity as President	Montrouge

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Various (measured at 1 month, 1 Year & 2 Year)
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	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.	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.	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	Day 0 Baseline
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..	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	Baseline Day 0
Secondary	The Use of Symbotex™ Composite Mesh and Surgery Duration	Operative Time (min) for patients treated for ventral hernia	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	Baseline Day 0