Overview

This trial is active, not recruiting.

Conditions primary and incisional abdominal wall, hernia surgeries using symbotex™ composite mesh by open or laparoscopic approach
Sponsor Medtronic - MITG
Start date July 2014
End date July 2017
Trial size 100 participants
Trial identifier NCT02206828, COVSYMB0441

Summary

The aim of this Observational Registry Study is to assess the short- and long-term clinicaloutcomes 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Only 1 group not predetermined

Primary Outcomes

Measure
Evaluate the incidence of peri-operative and post-operative complications, with postoperative evaluations occurring
time frame: 2 Year follow up

Secondary Outcomes

Measure
Description and assessment of the use of Symbotex™ Composite Mesh , surgeon's satisfaction, Quality of life and patient satisfaction...).
time frame: 2 Year follow up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Description This is an observational multicenter registry Study. One hundred consecutive, adult patients scheduled for primary and incisional abdominalwall hernia surgeries using Symbotex™ Composite Mesh will be reported in the ClubHernie online database, with standard data captured of all preoperative, perioperative andpost-operative data, for patient's outcomes measurements. Primary Objective: Evaluate the incidence of peri-operative and post-operative complications, with postoperativeevaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month(D30 follow up), 1Year and 2 Year follow up after primary and incisional abdominal wallhernia surgeries using Symbotex™ Composite Mesh by open or laparoscopic approach(such as anticipated device related complications such as pain, recurrence, complicationsrelated to adhesions, wound complications, other postoperative complications, SAE…). This online database consists of a systematic and consecutive data entry of all patientstreated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, withstandard 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic - MITG.