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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):
David R. Farley, Mayo Clinic

Brief Summary:
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Device: PROLENE Polypropylene Tacking Mesh Device: ProGrip Self-fixating Mesh Not Applicable

Detailed Description:
Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mean Operative Time [ Time Frame: First incision to closure, approximately one hour ]
    Length of time needed to complete surgery.

  2. Early Postoperative Complication [ Time Frame: Within 30 days ]
    Any complication which occurred within 30 days after the operation.


Secondary Outcome Measures :
  1. 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).

  2. Pain Score at One Week [ Time Frame: One Week ]
    Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).

  3. Pain Score at Four Weeks [ Time Frame: Four Weeks ]
    Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.

Exclusion Criteria:

- Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.


Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Farley Mayo Clinic

Responsible Party: David R. Farley, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03247985     History of Changes
Other Study ID Numbers: 13-003616
First Posted: August 14, 2017    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by David R. Farley, Mayo Clinic:
Mesh
Repair
Peritoneal

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal