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
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal||Device: PROLENE Polypropylene Tacking Mesh Device: ProGrip Self-fixating Mesh||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||November 30, 2015|
|Actual Study Completion Date :||November 30, 2015|
Active Comparator: PROLENE Polypropylene Tacking Mesh
Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.
Device: PROLENE Polypropylene Tacking Mesh
Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
Active Comparator: ProGrip Self-fixating Mesh
Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery
Device: 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
- Mean Operative Time [ Time Frame: First incision to closure, approximately one hour ]Length of time needed to complete surgery.
- Number of Participants With Early Postoperative Complications [ Time Frame: Within 30 days ]Any complication which occurred within 30 days after the operation.
- Pain Score at Baseline [ Time Frame: baseline ]Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
- Pain Score at One Week [ Time Frame: One Week Postoperative ]Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
- Pain Score at Four Weeks [ Time Frame: Four Weeks Postoperative ]Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247985
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905-0001|
|Principal Investigator:||David Farley||Mayo Clinic|