Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247985
• Other study ID #: 13-003616
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: November 30, 2015

Study information

• Verified date: May 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Operative Time	Length of time needed to complete surgery.	First incision to closure, approximately one hour
Primary	Number of Participants With Early Postoperative Complications	Any complication which occurred within 30 days after the operation.	Within 30 days
Secondary	Pain Score at Baseline	Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).	baseline
Secondary	Pain Score at One Week	Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).	One Week Postoperative
Secondary	Pain Score at Four Weeks	Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).	Four Weeks Postoperative