Trial Outcomes & Findings for Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair (NCT NCT03247985)

NCT ID: NCT03247985

Last Updated: 2018-06-15

Results Overview

Length of time needed to complete surgery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: First incision to closure, approximately one hour
• Results posted on: 2018-06-15

Participant Flow

Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.

Participant milestones

Measure	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
Overall Study STARTED	19	19
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PROLENE Polypropylene Tacking Mesh n=19 Participants 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 n=19 Participants 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 n=38 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 11 • n=19 Participants	55 years STANDARD_DEVIATION 11 • n=19 Participants	55 years STANDARD_DEVIATION 11 • n=38 Participants
Sex: Female, Male Female	0 Participants n=19 Participants	0 Participants n=19 Participants	0 Participants n=38 Participants
Sex: Female, Male Male	19 Participants n=19 Participants	19 Participants n=19 Participants	38 Participants n=38 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	19 participants n=19 Participants	19 participants n=19 Participants	38 participants n=38 Participants
Body Mass Index (BMI)	30 kg/m^2 STANDARD_DEVIATION 10 • n=19 Participants	30 kg/m^2 STANDARD_DEVIATION 4 • n=19 Participants	30 kg/m^2 STANDARD_DEVIATION 9 • n=38 Participants
Site of Hernia Unilateral	3 Participants n=19 Participants	8 Participants n=19 Participants	11 Participants n=38 Participants
Site of Hernia Bilateral	16 Participants n=19 Participants	11 Participants n=19 Participants	27 Participants n=38 Participants

PRIMARY outcome

Timeframe: First incision to closure, approximately one hour

Length of time needed to complete surgery.

Outcome measures

Measure	PROLENE Polypropylene Tacking Mesh n=19 Participants 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 n=19 Participants 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
Mean Operative Time Bilateral	69 minutes Standard Deviation 6.5	84 minutes Standard Deviation 7.8
Mean Operative Time Unilateral	40 minutes Standard Deviation 12	66 minutes Standard Deviation 7

PRIMARY outcome

Timeframe: Within 30 days

Any complication which occurred within 30 days after the operation.

Outcome measures

Measure	PROLENE Polypropylene Tacking Mesh n=19 Participants 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 n=19 Participants 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
Number of Participants With Early Postoperative Complications Overnight admittance to hospital	2 participants	1 participants
Number of Participants With Early Postoperative Complications Urinary retention	1 participants	1 participants
Number of Participants With Early Postoperative Complications Skin infection	1 participants	0 participants
Number of Participants With Early Postoperative Complications Recurrence of hernia	0 participants	1 participants

SECONDARY outcome

Timeframe: baseline

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

Outcome measures

Measure	PROLENE Polypropylene Tacking Mesh n=19 Participants 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 n=19 Participants 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
Pain Score at Baseline	1.13 units on a scale Standard Deviation 1.196	1.5 units on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	PROLENE Polypropylene Tacking Mesh n=19 Participants 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 n=19 Participants 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
Pain Score at One Week	1.1 units on a scale Standard Deviation 0.904	0.8 units on a scale Standard Deviation 0.747

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	PROLENE Polypropylene Tacking Mesh n=19 Participants 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 n=19 Participants 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
Pain Score at Four Weeks	0.1 units on a scale Standard Deviation 0.236	0.3 units on a scale Standard Deviation 0.757

Adverse Events

PROLENE Polypropylene Tacking Mesh

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

ProGrip Self-fixating Mesh

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROLENE Polypropylene Tacking Mesh n=19 participants at risk 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 n=19 participants at risk 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
Renal and urinary disorders Admission to hospital	10.5% 2/19 • Number of events 2 • One month	5.3% 1/19 • Number of events 1 • One month

Other adverse events

Measure	PROLENE Polypropylene Tacking Mesh n=19 participants at risk 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 n=19 participants at risk 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
Renal and urinary disorders Urinary Retention	5.3% 1/19 • Number of events 1 • One month	5.3% 1/19 • Number of events 1 • One month
Gastrointestinal disorders Inguinal Hernia Recurrence	0.00% 0/19 • One month	5.3% 1/19 • Number of events 1 • One month

Additional Information

Dr. David R. Farley

Mayo Clinic

Phone: 507-284-7565

Email: farley.david@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place