N/A
Completed N=100
The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Ventral Incisional Hernia
Source: ClinicalTrials.gov NCT02206828 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Incidence of Peri-operative and Post-operative Complications — 0; 1; 0 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Peri-operative and Post-operative Complications |
0; 1; 0 | — |
| SECONDARY Pain Assessment Measured With VAS Score |
4.7; 3.9; 2.0; 0.8; 0.2; 0.0 | — |
| SECONDARY Quality of Life for Patient |
0; 90; 91; 0; 4; 2 | — |
| SECONDARY Patient Satisfaction |
10; 7; 73; 79; 7; 3 | — |
| SECONDARY Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use) |
102; 80; 102; 94; 92; 0 | — |
| SECONDARY Mesh Handling |
68; 34; 32; 53; 74; 51 | — |
| SECONDARY The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair |
20; 77; 3 | — |
| SECONDARY The Use of Symbotex™ Composite Mesh and Surgery Duration |
67.4; 36.2; 68.3 | — |
| SECONDARY The Use of Symbotex™ Composite Mesh and Hospital Stay Duration |
4.7; 1.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02206828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.