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An ongoing prospective study evaluating self-gripping mesh (Parietex Progrip) without additional fixation during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: interim analysis at one year

Andrew S Wu, MD, Min Li, MS, Mark Reiner, MD, Brian P Jacob, MD

Mount Sinai Medical Center, New York City

Background: Self-gripping mesh may eliminate the need for any additional fixation devices during inguinal hernia repairs. However, its use and outcomes (quality of life and recurrence rates) are not yet prospectively studied in a controlled fashion for laparoscopic TEP repairs.

Methods: After completing more than 50 laparoscopic inguinal hernia repairs using self-gripping mesh, under an IRB-approved prospective study we began evaluating our next 100 TEPs. Patient demographics and intraoperative data (defect location, size, mesh deployment time) are recorded. Carolinas Comfort Scale ™ (CCS), a validated 0-5 pain and quality of life (QoL) score where a mean score of >1.0 is considered symptomatic pain, is employed to evaluate pain and quality of life in the recovery room and post-operatively at 2 weeks, 6 months, and one year. Morbidities, narcotic usage, days to full activity, days to return to work, and CCS scores for the initial patients enrolled are reported.

Results: Since July 2011, we repaired 93 hernias in 66 patients with self-gripping mesh without any additional fixation. 19 hernias were direct defects (average size 2.8cm), 66 were indirect, and 2 were femoral while 6 were Pantaloon hernias. Two minor intraoperative morbidities (minor bleeding and transient bradycardia) occurred and average mesh deployment time was 198 seconds. Recovery room pain was 1.1 / 5. At the 2 week visit, total average oxycodone/acetaminophen (5mg/325mg) usage was 5.4 tablets, days to full activity was 1.7, and return to work was 4.5 days. 12 small asymptomatic seromas were palpated without any recurrences or groin numbness. All seromas resolved by the 6 month visit. Transient testis discomfort (present at first visit, but not subsequent visits) was reported in 8 patients. Urinary retention was 3%. Mean CCS™ scores for groin pain laying, bending, sitting, walking, and step-climbing were 0.2, 0.6, 0.3, 0.5, and 0.07 respectively. Mean CCS scores greater than 1.0 occurred in 6% of 66 patients at the first post op visit (range 0-1.78), but 0 % of 30 patients at 6 months, and thus far 0% of 11 patients at one year (range 0 – 0.8). Of the first 11 patients over a year out, none have a recurrence or chronic pain.

Conclusions: Results of this study suggest that using self-gripping mesh without additional fixation during laparoscopic TEP repairs for direct, indirect, and femoral hernias is feasible, leading to a durable repair without significant morbidity. CCS™ pain and QoL scores are very favorable at subsequent post-operative visits followed out for over a year.


Session: Podium Presentation

Program Number: S116

930

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