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

NCT02206828 | Completed Results DMC

• 1 other identifier: COVSYMB0441
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Ventral Incisional Hernia

Keywords

HERNIA; SYMCHRO; SOFRADIM; REGISTRY; SYMBOTEX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain Assessment Measured With VAS Score

  Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year

• Quality of Life for Patient

  Various ( 1 Month, 1 year and 2 Year follow up)

• Patient Satisfaction

  Various (1 year and 2 year)

• Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)

  Day 0 Baseline

• Mesh Handling

  Day 0 Baseline

Study Arms (1)

1 GROUP

Only 1 group not predetermined

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients scheduled for primary and incisional abdominal wall hernia surgeries

You may qualify if:

• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

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

Montrouge, 92120, France

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Djamila Bennat
• Organization: Medtronic

djamila.bennat@medtronic.com

33474089000

Study Officials

• Jean-François Gillion

  ICMJE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: August 1, 2014
• Study Start: June 25, 2014
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: January 14, 2025
• Results First Posted: November 1, 2019

Record last verified: 2024-12

Locations

FR (1)