Incidence, risks & costs

Port Site Herniation is a specific complication of laparoscopic surgery which is often underestimated.2

Up to 5.2% of patients undergoing laparoscopic surgery will experience a port-site hernia.4

A clinical study of patients showed that these rates can be as high as 25.9% three years post procedure.5

Port site herniation is costly

For example, in the United States alone, there are:

~64,000 procedures to repair port‑site hernias each year,6 which cost…

~$7,000 per additional surgery to address the herniation.7 That may add a burden of up to…

~$446M on the U.S. healthcare system.8

Port site herniation: An increasingly frequent complication, yet preventable

Minimally Invasive Surgery (MIS) using laparoscopic or catheter-based techniques has become an increasingly common alternative to traditional open surgery.9,10

With a higher number of MIS procedures, the incidence of port site herniation is only expected to rise11

The recommendation is to close all defects larger than 10mm.12

Risk factors for port-site hernias include:4

  • Inconsistent closures
  • Larger sized trocars (10 mm and greater)
  • Long procedures
  • Trocar location
  • Age
  • High BMI

Reducing risks

All fascial defects larger than 10 mm should be closed to prevent port site herniation4

5 mm fascia capture on either side of the trocar has been shown to reduce the potential risk for herniation3

Special attention to fascial closure techniques (hand suturing, suture passers and wound closure devices) is important as results can be inconsistent13,14

OUR SOLUTION TO PORT SITE CLOSURE CHALLENGES

Consistent 5 mm Bite

In abdominal wound closure, small 5 mm bites have been shown to reduce incisional hernias.13–16,†

The VersaOne™ fascial closure device system is an all-in-one3 system designed for consistent port site closure. It allows surgeons to close fascia 5 mm on either side of trocar wound.11

The VersaOne™ fascial closure system maintains the pneumoperitoneum within the abdominal cavity by eliminating the need to remove a trocar before closure begins, delivering:

  • Added procedural efficiency3,†
  • Ease of use3
  • † Compared to the competitive closure device, suture passers, and hand sutures.

  • 1. Mikhail, Emad & Hart, Stuart. (2014). Laparoscopic port closure. Surgical technology international. 24. 27-33. Helgstrand F, Rosenberg J, Bisgaard T. Trocar site hernia after laparoscopic surgery: a qualitative systematic review. Hernia. 2010;15(2):113–121.

  • 2. Mohan Venkatesh Pulle*, Rahul Siddhartha, Ashish Dey, Tarun Mittal, Vinod K. Malik, Port site hernia in laparoscopic surgery: Mechanism, prevention and management

  • 3. Based on internal validation report #RE00098009 rev A, DoubleTime VersaOne™ fascial closure system Miami lab VOC report: 13 out of 16 surgeons surveyed agreed. March28, 2017.

  • 4. Helgstrand F, Rosenberg J, Bisgaard T. Trocar site hernia after laparoscopic surgery: a qualitative systematic review. Hernia. 2010;15(2):113–121.

  • 5. Comajuncosas J, Hermoso J, Gris P, et al. Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg.2014;207(1):1–6.

  • 6. Based on the Medicare national average for 2017; $6,970 outpatient reimbursement; laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed).

  • 7. Based on internal U.S. data, Market model hernia procedure. 2017.

  • 8. Based on a calculation of $446 million for the number of procedures (64,000) multiplied by cost per additional surgery ($6,970).

  • 9. Fullum TM, Lapado JA, Borah BJ. Gunnarsson CL. Comparison of the clinical and economic outcomes between open and minimally invasive appendectomy and colectomy: evidence from a large commercial payer database. Surg Endosc. 2010;28:845-853

  • 10. Fitch, K & Engel, T & Bochner, A. (2015). Cost Differences Between Open and Minimally Invasive Surgery. Managed care (Langhorne, Pa.). 24. 40-48

  • 11. Nadler RB, McDougall E, Bullock AD, Ludwig MA, Brunt LM. Fascial closure of laparoscopic port sites: a new technique. Urology. 1995;45(6):1046–1048.

  • 12. Shaher, Z, Port closure techniques Surgical Endoscopy [Surg Endosc] 2007 Aug; Vol. 21 (8), pp. 1264-74

  • 13. Based on internal report #RE00079705, Fascial closure system bite size verification. Nov. 5, 2014.

  • 14. Eid GM, Collins J. Application of a trocar wound closure system designed for laparoscopic procedures in morbidly obese patients. Obes Surg. 2005;15(6):871–873.

  • 15. Muysoms FE, Antoniou SA, Bury K, et al. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015;19:1–24.

  • 16. Harris HW, Hope WH, Adrales G, et al. Contemporary concepts in hernia prevention: Selected proceedings from the 2017 International Symposium on Prevention of Incisional Hernias. Surgery. 2018;164(2):319–326.

  • 17. Deerenberg EB, Harlaar JJ, Kleinrensink GJ, et al. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial; Lancet. 2015; 386:1254–1260.

  • 18. Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009;14 (11):1056 – 1059.

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