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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 : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PROLENE Polypropylene Tacking Mesh

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

ProGrip Self-fixating Mesh

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


Participant Flow:   Overall Study
    PROLENE Polypropylene Tacking Mesh   ProGrip Self-fixating Mesh
STARTED   19   19 
COMPLETED   19   19 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PROLENE Polypropylene Tacking Mesh

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

ProGrip Self-fixating Mesh

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 Total of all reporting groups

Baseline Measures
   PROLENE Polypropylene Tacking Mesh   ProGrip Self-fixating Mesh   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   38 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 19   19   38 
   58  (11)   55  (11)   55  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 19   19   38 
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] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 19   19   38 
United States   19   19   38 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 19   19   38 
   30  (10)   30  (4)   30  (9) 
Site of Hernia 
[Units: Participants]
Count of Participants
     
Unilateral       
Participants Analyzed 
[Units: Participants]
 19   19   38 
Unilateral   3   8   11 
Bilateral       
Participants Analyzed 
[Units: Participants]
 19   19   38 
Bilateral   16   11   27 


  Outcome Measures

1.  Primary:   Mean Operative Time   [ Time Frame: First incision to closure, approximately one hour ]

2.  Primary:   Early Postoperative Complication   [ Time Frame: Within 30 days ]

3.  Secondary:   Pain Score at Baseline   [ Time Frame: baseline ]

4.  Secondary:   Pain Score at One Week   [ Time Frame: One Week ]

5.  Secondary:   Pain Score at Four Weeks   [ Time Frame: Four Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: farley.david@mayo.edu



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: November 17, 2017