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Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

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ClinicalTrials.gov Identifier: NCT03247985
Recruitment Status : Completed
First Posted : August 14, 2017
Results First Posted : November 17, 2017
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
David R. Farley, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hernia, Inguinal
Interventions Device: PROLENE Polypropylene Tacking Mesh
Device: ProGrip Self-fixating Mesh
Enrollment 38
Recruitment Details Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.
Pre-assignment Details  
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Period Title: Overall Study
Started 19 19
Completed 19 19
Not Completed 0 0
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh Total
Hide Arm/Group Description

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
58  (11) 55  (11) 55  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
19
 100.0%
19
 100.0%
38
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 19 participants 38 participants
30  (10) 30  (4) 30  (9)
Site of Hernia  
Measure Type: Count of Participants
Unit of measure:  Participants
Unilateral Number Analyzed 19 participants 19 participants 38 participants
3
  15.8%
8
  42.1%
11
  28.9%
Bilateral Number Analyzed 19 participants 19 participants 38 participants
16
  84.2%
11
  57.9%
27
  71.1%
1.Primary Outcome
Title Mean Operative Time
Hide Description Length of time needed to complete surgery.
Time Frame First incision to closure, approximately one hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description:

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: minutes
Bilateral 69  (6.5) 84  (7.8)
Unilateral 40  (12) 66  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROLENE Polypropylene Tacking Mesh, ProGrip Self-fixating Mesh
Comments Comparison between groups for bilateral operative time.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PROLENE Polypropylene Tacking Mesh, ProGrip Self-fixating Mesh
Comments Comparison between groups for unilateral operative time.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Early Postoperative Complications
Hide Description Any complication which occurred within 30 days after the operation.
Time Frame Within 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description:

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: participants
Overnight admittance to hospital 2 1
Urinary retention 1 1
Skin infection 1 0
Recurrence of hernia 0 1
3.Secondary Outcome
Title Pain Score at Baseline
Hide Description Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description:

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.13  (1.196) 1.5  (1.29)
4.Secondary Outcome
Title Pain Score at One Week
Hide Description Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time Frame One Week Postoperative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description:

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (0.904) 0.8  (0.747)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROLENE Polypropylene Tacking Mesh, ProGrip Self-fixating Mesh
Comments A p-value of 0.05 was considered statistically significant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Pain Score at Four Weeks
Hide Description Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time Frame Four Weeks Postoperative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description:

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (0.236) 0.3  (0.757)
Time Frame One month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Hide Arm/Group Description

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of “Velcro” to the soft tissue surfaces resulting in self-fixation

All-Cause Mortality
PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/19 (10.53%)      1/19 (5.26%)    
Renal and urinary disorders     
Admission to hospital  [1]  2/19 (10.53%)  2 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
Bladder catheterization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PROLENE Polypropylene Tacking Mesh ProGrip Self-fixating Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      2/19 (10.53%)    
Gastrointestinal disorders     
Inguinal Hernia Recurrence   0/19 (0.00%)  0 1/19 (5.26%)  1
Renal and urinary disorders     
Urinary Retention   1/19 (5.26%)  1 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
The small sample size limits the power to reflect statistical differences. This study had a large number of bilateral repairs reflecting the inherent referral bias of our practice.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David R. Farley
Organization: Mayo Clinic
Phone: 507-284-7565
Responsible Party: David R. Farley, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03247985     History of Changes
Other Study ID Numbers: 13-003616
First Submitted: August 10, 2017
First Posted: August 14, 2017
Results First Submitted: October 19, 2017
Results First Posted: November 17, 2017
Last Update Posted: June 15, 2018