Trial Outcomes & Findings for The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair (NCT NCT02206828)
NCT ID: NCT02206828
Last Updated: 2025-01-14
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
Various (measured at 1 month, 1 Year & 2 Year)
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Symbotex Composite Mesh
Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Symbotex Composite Mesh
Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Symbotex Composite Mesh
n=100 Participants
Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 13.7 • n=100 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=100 Participants
|
|
Region of Enrollment
France
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Various (measured at 1 month, 1 Year & 2 Year)Population: 6 patients are lost to follow up at 1 year - 7 patients are lost to follow up at 2 year , it is described in the Participant Flow module Outcomes measure reflect Patients who completed each visits
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
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=100 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
n=94 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
n=93 Participants
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
Incidence of Peri-operative and Post-operative Complications
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 yearPain 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
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=82 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
n=79 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
n=76 Participants
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
n=79 Participants
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
n=24 Participants
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
n=3 Participants
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
n=2 Participants
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
Pain Assessment Measured With VAS Score
|
4.7 units on a scale
Standard Deviation 2.5
|
3.9 units on a scale
Standard Deviation 1.8
|
2.0 units on a scale
Standard Deviation 1.7
|
0.8 units on a scale
Standard Deviation 1.8
|
0.2 units on a scale
Standard Deviation 0.7
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Various ( 1 Month, 1 year and 2 Year follow up)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.
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=82 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
n=94 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
n=93 Participants
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
Quality of Life for Patient
Does the abdominal wall seem firm? · Yes
|
0 Participants
|
90 Participants
|
91 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Does the abdominal wall seem firm? · No
|
0 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Does the abdominal wall seem firm? · Not assessed
|
82 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Do you feel a lump? · Yes
|
0 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Do you feel a lump? · No
|
0 Participants
|
87 Participants
|
91 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Do you feel a lump? · Not assessed
|
82 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Do you feel any pain or discomfort? · Yes
|
20 Participants
|
23 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Do you feel any pain or discomfort? · No
|
62 Participants
|
71 Participants
|
81 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Do you feel any pain or discomfort? · Not assessed
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Reoperation needed? · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Reoperation needed? · No
|
82 Participants
|
94 Participants
|
92 Participants
|
—
|
—
|
—
|
—
|
|
Quality of Life for Patient
Reoperation needed? · Not assessed
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Various (1 year and 2 year)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.
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=94 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
n=91 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
Patient Satisfaction
Excellent
|
10 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction
Good
|
73 Participants
|
79 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction
Medium
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Patient Satisfaction
Bad
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 BaselinePopulation: Number of Hernia, some patients exhibits more than 1 hernia (100 patients with 105 ventral hernias) Ease of use: results is based on 100 patients and 105 hernias (100 patients enrolled and having 105 hernias) , However results reported of subjects with missing data or not applicable data respectively;
Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=102 Hernia
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
n=80 Hernia
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
n=102 Hernia
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
n=96 Hernia
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
n=92 Hernia
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)
Satisfying
|
102 Hernia
|
80 Hernia
|
102 Hernia
|
94 Hernia
|
92 Hernia
|
—
|
—
|
|
Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)
Unsatisfying
|
0 Hernia
|
0 Hernia
|
0 Hernia
|
2 Hernia
|
0 Hernia
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 Baselineease 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..
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=100 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
Mesh Handling
Marking eases to place
|
68 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mesh Handling
conformability to the anatomy is useful
|
34 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mesh Handling
Absence of direction for positioning is useful
|
32 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mesh Handling
Prothesis Shape memory eases to place
|
53 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mesh Handling
Mesh transparency eases to place
|
74 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mesh Handling
Mesh easy to re-place
|
51 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mesh Handling
The mesh does not twist during stapling
|
43 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Day 0Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=100 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
Open (Laparotomy)
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
Laparoscopy
|
77 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
Open then Laparoscopy
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Day 0Population: 3 approaches of surgery , thus operative time and hospital stay are provided according to the nature of the surgery the unit of Operative time is in minutes (specify in the title see below) And the unit of hospital stay is in days (speify in the title see below) Missing data on 4 patients.
Operative Time (min) for patients treated for ventral hernia
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=96 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
The Use of Symbotex™ Composite Mesh and Surgery Duration
Open (Laparotomy)
|
67.4 minutes
Standard Deviation 25.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Use of Symbotex™ Composite Mesh and Surgery Duration
Laparoscopy
|
36.2 minutes
Standard Deviation 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Use of Symbotex™ Composite Mesh and Surgery Duration
Open then Laparoscopy
|
68.3 minutes
Standard Deviation 32.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Day 0Population: For 8 patients there is 8 missing data respectively
Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device
Outcome measures
| Measure |
Recurence Rate at 1 Month
n=89 Participants
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 1 Year
Recurrence rate following patients treated for ventral hernia
|
Recurrence Rate at 2 Year
Recurrence rate following patients treated for ventral hernia
|
VAS Pain Assessment Month 1
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment Month 3
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 1 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
VAS Pain Assessment 2 Year
Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|---|---|---|---|---|---|
|
The Use of Symbotex™ Composite Mesh and Hospital Stay Duration
Open (Laparotomy)
|
4.7 days
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Use of Symbotex™ Composite Mesh and Hospital Stay Duration
Laparoscopy
|
1.6 days
Standard Deviation 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Symbotex Composite Mesh
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Symbotex Composite Mesh
n=100 participants at risk
Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach
|
|---|---|
|
Blood and lymphatic system disorders
Seroma
|
6.0%
6/100 • 24 months
|
|
Gastrointestinal disorders
Transitory ileus
|
3.0%
3/100 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place