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Completed

NCT Number: NCT03247985

Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

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.

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROLENE Polypropylene Tacking Mesh

Device

Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

ProGrip Self-fixating Mesh

Device

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 outcomes

  1. Mean Operative Time

    Time frame: First incision to closure, approximately one hour

    Length of time needed to complete surgery.

  2. Number of Participants With Early Postoperative Complications

    Time frame: Within 30 days

    Any complication which occurred within 30 days after the operation.

Secondary outcomes

  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 Postoperative

    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 Postoperative

    Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2017
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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