Trial Outcomes & Findings for ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention (NCT NCT03912662)
NCT ID: NCT03912662
Last Updated: 2025-12-03
Results Overview
Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
24 months
Results posted on
2025-12-03
Participant Flow
A subject is considered enrolled in the study when it is confirmed they meet all pre-operative inclusion and no exclusion criteria, the Informed Consent Form is signed and they have been implanted with the device.
Participant milestones
| Measure |
Patients Consented for POETRY Study
Patients consented for POETRY Study and may recieve ProGrip™ Self-Gripping Polyester Mesh.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Enrolled (Received Study Device)
|
32
|
|
Overall Study
Safety Analysis Set
|
32
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Patients Consented for POETRY Study
Patients consented for POETRY Study and may recieve ProGrip™ Self-Gripping Polyester Mesh.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Adverse Event and Death
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Screen Failure: Subjects who provide study consent, but then were determined to be ineligible.
|
1
|
|
Overall Study
Mesh Removal
|
1
|
|
Overall Study
Discontinued: Eligible consented subjects who did not undergo the procedure with the study device.
|
2
|
|
Overall Study
Early study termination
|
20
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
n=32 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled who received the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 13.19 • n=32 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=32 Participants
|
|
Weight
|
73.6 kg
STANDARD_DEVIATION 17.96 • n=32 Participants
|
|
Height
|
169.5 cm
STANDARD_DEVIATION 9.26 • n=32 Participants
|
|
BMI
|
25.5 kg/m^2
STANDARD_DEVIATION 5.66 • n=32 Participants
|
|
Work
Unemployed
|
16 Participants
n=32 Participants
|
|
Work
Administrative work
|
4 Participants
n=32 Participants
|
|
Work
Moderately physical labor
|
5 Participants
n=32 Participants
|
|
Work
Physical labor
|
3 Participants
n=32 Participants
|
|
Work
Not Provided
|
4 Participants
n=32 Participants
|
|
Sport Activity
None
|
14 Participants
n=32 Participants
|
|
Sport Activity
Intense (>1x/week)
|
3 Participants
n=32 Participants
|
|
Sport Activity
Moderate (1x/week)
|
14 Participants
n=32 Participants
|
|
Sport Activity
Sporadic
|
1 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=4 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Incisional Hernia Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: From the surgery to the 24-month visitPopulation: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=32 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Adverse Event
Total Number of Adverse Events
|
39 Adverse Events
|
|
Adverse Event
AEs by reason for Seriousness: Hospitalization
|
18 Adverse Events
|
|
Adverse Event
AEs by reason for Seriousness: Death
|
2 Adverse Events
|
|
Adverse Event
AEs by reason for Seriousness: Life threatening illness or injury
|
8 Adverse Events
|
|
Adverse Event
AEs by reason for Seriousness: Permanent impairment of a body structure or body function
|
1 Adverse Events
|
|
Adverse Event
AEs by reason for Seriousness: Medical or surgical intervention
|
19 Adverse Events
|
|
Adverse Event
AEs by Relation to Study Device: Not Related
|
31 Adverse Events
|
|
Adverse Event
AEs by Relation to Index Procedure: Not Related
|
12 Adverse Events
|
|
Adverse Event
AEs by Relation to Index Procedure: Related
|
27 Adverse Events
|
|
Adverse Event
AEs by Relation to Mesh Placement Procedure: Not Related
|
24 Adverse Events
|
|
Adverse Event
AEs by Relation to Mesh Placement Procedure: Related
|
4 Adverse Events
|
|
Adverse Event
Number of Index Procedure related AEs
|
27 Adverse Events
|
|
Adverse Event
Number of Index Procedure related SAEs
|
14 Adverse Events
|
|
Adverse Event
Number of AEs with action taken
|
38 Adverse Events
|
|
Adverse Event
AEs by Relation to Study Device: Related
|
8 Adverse Events
|
|
Adverse Event
Number of SAEs
|
25 Adverse Events
|
|
Adverse Event
Number of non-Serious AEs
|
14 Adverse Events
|
|
Adverse Event
Number of Device-Related AEs
|
8 Adverse Events
|
|
Adverse Event
Number of Mesh Placement Procedure-related AEs
|
5 Adverse Events
|
|
Adverse Event
Number of Device-related SAEs
|
6 Adverse Events
|
|
Adverse Event
Number of Mesh Placement Procedure-related SAEs
|
3 Adverse Events
|
SECONDARY outcome
Timeframe: From the surgery to the 24-month visitPopulation: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
Time to incisional hernia occurrence from the surgery to the 24-month visit
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=32 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Time to Incisional Hernia Occurrence
|
384 Days to hernia occurrence
Interval 384.0 to 384.0
|
SECONDARY outcome
Timeframe: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
Post-operative pain at the site of the surgery was measured at days 0, 1, 8 and months 1, 12, 24 using a Visual Analog Scale - a psychometric response scale (0-10) (0 no pain, 10 the worst) either during systematic clinical visit or by phone call when a subject is already discharged. (Worst pain experienced over the last 24 hours).
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=30 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Post-operative Pain at the Site of Surgery
EVA (VAS) Day 0
|
3.8 score on a scale of 0-10
Standard Deviation 2.94
|
|
Post-operative Pain at the Site of Surgery
EVA (VAS) Day 1
|
3.7 score on a scale of 0-10
Standard Deviation 2.73
|
|
Post-operative Pain at the Site of Surgery
EVA (VAS) Month 24
|
0 score on a scale of 0-10
Standard Deviation 0
|
|
Post-operative Pain at the Site of Surgery
EVA (VAS) Day 8
|
1.9 score on a scale of 0-10
Standard Deviation 2.42
|
|
Post-operative Pain at the Site of Surgery
EVA (VAS) Month 1
|
0.4 score on a scale of 0-10
Standard Deviation 0.91
|
|
Post-operative Pain at the Site of Surgery
EVA (VAS) Month 12
|
0.5 score on a scale of 0-10
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Month 1, Month 12, Month 24Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
Assessment with Club Hernie Registry QOL questionnaire of patients treated with ProGrip Self-Gripping Polyester Mesh for suture line mesh reinforcement. . Two sets of self-administered QOL were administered; one for 1 month and one for 12- and 24-month.
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=25 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1 : Post-operative discomfort: No symptoms
|
16 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1 : Post-operative discomfort: Discomfort
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Post-operative discomfort: Other symptoms
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24 : Post-operative discomfort: No symptoms
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Post-operative discomfort: Reduced sensitivity
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Location of symptoms: Not applicable
|
17 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Location of symptoms: Side operated on
|
6 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Location of symptoms: Contralateral
|
2 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Location of symptoms: Elsewhere
|
2 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Location of symptoms: Response missing
|
7 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Timing of symptoms: Not applicable
|
19 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Timing of symptoms: after exertion or end of day
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Timing of symptoms: Anytime
|
2 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Timing of symptoms: During other activities
|
2 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Timing of symptoms: Response missing
|
7 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Frequency of symptoms: Not applicable
|
19 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Frequency of symptoms: Several times per day
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Frequency of symptoms: Often during day
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Impact of symptoms on activities: Not applicable
|
19 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Impact of symptoms on activities: prohibits certain activities
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Impact of symptoms on activities: temporary stop of activities
|
2 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Impact of symptoms on activities: continue activities
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Impact of symptoms on activities: response missing
|
7 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: pre- and post-operative pain: Not applicable
|
21 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: pre- and post-operative pain: post-operative discomfort < Hernia discomfort
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: pre- and post-operative pain: response missing
|
7 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Location of symptoms: Not applicable
|
15 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Location of symptoms: Elsewhere
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Timing of symptoms: Not applicable
|
15 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Timing of symptoms: After exertion or end of day
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Frequency of symptoms: Not applicable
|
15 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Frequency of symptoms: Often during day
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Impact of symptoms on activities: Not applicable
|
15 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: pre- and post-operative pain: Response missing
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Location of symptoms: Not applicable
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Location of symptoms: Bilateral
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Timing of symptoms: Not applicable
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Timing of symptoms: Anytime
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Frequency of symptoms: Not applicable
|
4 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Impact of symptoms on activities: Not applicable
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Impact of symptoms on activities: Does not disrupt activities
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: pre- and post-operative pain: Not applicable
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: pre- and post-operative pain: post-operative discomfort < Hernia discomfort
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Perception of structure of abdominal wall: Solid
|
16 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Perception of lump in abdominal wall: No
|
15 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Perception of lump in abdominal wall: Elsewhere
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Perception of structure of abdominal wall: Solid
|
4 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 24: Perception of lump in abdominal wall: No
|
4 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Post-operative discomfort: Tingling (dyesthesia, hyperesthesia, hyperpathia)
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Post-operative discomfort: Reduced sensitivity
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Post-operative discomfort: Moderated pain per Visual Analog Scale (VAS)
|
3 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Post-operative discomfort: Response missing
|
8 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12 : Post-operative discomfort: No symptoms
|
14 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Post-operative discomfort: Significant pain
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Post-operative discomfort: Other symptoms
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Frequency of symptoms: All day
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Frequency of symptoms: 24 hours a day
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 1: Frequency of symptoms: Response missing
|
7 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: Impact of symptoms on activities: Prohibits certain activities
|
1 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: pre- and post-operative pain: Not applicable
|
14 participants
|
|
Quality of Life Questionnaire (QOL) for Patient
Month 12: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort
|
1 participants
|
SECONDARY outcome
Timeframe: Day 0Population: Surgeons who placed the ProGrip Self-Gripping Polyester Mesh during midline laparotomy procedures.
Surgeon satisfaction on mesh ease of use and manipulability.
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=26 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Surgeon Satisfaction
Mesh shape memory : Satisfactory
|
24 surgeons
|
|
Surgeon Satisfaction
Mesh shape memory : Unsatisfactory
|
1 surgeons
|
|
Surgeon Satisfaction
Mesh shape memory : Not Stated
|
1 surgeons
|
|
Surgeon Satisfaction
Mesh placement - adhesion to the wall
|
17 surgeons
|
|
Surgeon Satisfaction
Mesh placement - absence of laying direction
|
8 surgeons
|
|
Surgeon Satisfaction
Mesh placement - shape memory
|
5 surgeons
|
|
Surgeon Satisfaction
Mesh placement - transparency
|
8 surgeons
|
|
Surgeon Satisfaction
Mesh placement - easy to reposition
|
12 surgeons
|
|
Surgeon Satisfaction
Flexibility of the Mesh : Satisfactory
|
25 surgeons
|
|
Surgeon Satisfaction
Flexibility of the Mesh : Not Stated
|
1 surgeons
|
|
Surgeon Satisfaction
Cuttable : Satisfactory
|
24 surgeons
|
|
Surgeon Satisfaction
Cuttable : Not Stated
|
2 surgeons
|
SECONDARY outcome
Timeframe: Month 12, Month 24Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement.
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=16 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Patient Satisfaction
Month 12: Repeat Procedure Performed = No
|
14 participants
|
|
Patient Satisfaction
Month 12: Repeat Procedure Performed = Response Missing
|
2 participants
|
|
Patient Satisfaction
Month 12: Strength of abdominal wall = Excellent
|
5 participants
|
|
Patient Satisfaction
Month 12: Strength of abdominal wall = Good
|
5 participants
|
|
Patient Satisfaction
Month 12: Strength of abdominal wall = Moderate
|
1 participants
|
|
Patient Satisfaction
Month 12: Strength of abdominal wall = Poor
|
1 participants
|
|
Patient Satisfaction
Month 12: Strength of abdominal wall = response missing
|
4 participants
|
|
Patient Satisfaction
Month 24: Repeat Procedure Performed = No
|
4 participants
|
|
Patient Satisfaction
Month 24: Strength of abdominal wall = Excellent
|
1 participants
|
|
Patient Satisfaction
Month 24: Strength of abdominal wall = Good
|
3 participants
|
|
Patient Satisfaction
Month 24: Strength of abdominal wall = Poor
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0Population: Surgeons who placed the ProGrip Self-Gripping Polyester Mesh during midline laparotomy procedures.
Time to position the mesh
Outcome measures
| Measure |
Patients Treated With ProGrip Self-Gripping Polyester Mesh: Gripping Polyester Mesh
n=20 Participants
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled receiving the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Surgeon Satisfaction
|
8.0 minutes
Standard Deviation 6.34
|
Adverse Events
Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
Serious events: 10 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
n=32 participants at risk
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled will receive the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Infections and infestations
Septic shock
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
6.2%
2/32 • Number of events 2 • surgery to the 24-month visit
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
2/32 • Number of events 2 • surgery to the 24-month visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Surgical and medical procedures
Small intestinal resection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Vascular disorders
Haematoma
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Vascular disorders
Shock
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Cardiac disorders
Arrhythmia
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Ileus
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Pancreatitis acute
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
General disorders
Swelling
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Infections and infestations
Escherichia infection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
Other adverse events
| Measure |
Patients Treated With ProGrip™ Self-Gripping Polyester Mesh
n=32 participants at risk
ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled will receive the ProGrip™ Self-Gripping Polyester Mesh
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Number of events 2 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Fistula of small intestine
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Ileus
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Pancreatitis acute
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Gastrointestinal disorders
Steatorrhoea
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
General disorders
Inflammation
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
General disorders
Swelling
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Infections and infestations
Escherichia infection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Infections and infestations
Septic shock
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Infections and infestations
Vascular device infection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Seroma
|
6.2%
2/32 • Number of events 2 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
6.2%
2/32 • Number of events 2 • surgery to the 24-month visit
|
|
Investigations
Investigation
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Nervous system disorders
Hypoaesthesia
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
2/32 • Number of events 2 • surgery to the 24-month visit
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Surgical and medical procedures
Small intestinal resection
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Vascular disorders
Deep vein thrombosis
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Vascular disorders
Haematoma
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
|
Vascular disorders
Shock
|
3.1%
1/32 • Number of events 1 • surgery to the 24-month visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place