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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Active Comparator | Participants will be randomized to Tacking Mesh for their inguinal hernia surgery. |
|
| ProGrip Self-fixating Mesh | Active Comparator | Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROLENE Polypropylene Tacking Mesh | Device | Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Operative Time | Length of time needed to complete surgery. | First incision to closure, approximately one hour |
| Number of Participants With Early Postoperative Complications | Any complication which occurred within 30 days after the operation. | Within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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). |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| David Farley | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905-0001 | United States |
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Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | ProGrip Self-fixating Mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Operative Time | Length of time needed to complete surgery. | Posted | Mean | Standard Deviation | minutes | First incision to closure, approximately one hour |
|
One month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admission to hospital | Renal and urinary disorders | Systematic Assessment | Bladder catheterization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
The small sample size limits the power to reflect statistical differences. This study had a large number of bilateral repairs reflecting the inherent referral bias of our practice.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David R. Farley | Mayo Clinic | 507-284-7565 | farley.david@mayo.edu |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
|
| One Week Postoperative |
| 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 |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Site of Hernia | Count of Participants | Participants |
|
|
|
|
| Primary | Number of Participants With Early Postoperative Complications | Any complication which occurred within 30 days after the operation. | Posted | Number | participants | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | Four Weeks Postoperative |
|
|
|
| 0 |
| 19 |
| 2 |
| 19 |
| 1 |
| 19 |
| EG001 | 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 | 0 | 19 | 1 | 19 | 2 | 19 |
|
| Inguinal Hernia Recurrence | Gastrointestinal disorders | Systematic Assessment |
|
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| Skin infection |
|
| Recurrence of hernia |
|