NCT02206828

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ventral Incisional Hernia

Timeline

• Start date: 2014-06-25
• Primary completion: 2017-05-22
• Completion: 2017-05-22
• First posted: 2014-08-01
• Last updated: 2025-01-14
• Results posted: 2019-11-01

Locations

1 site across 1 country: France