JOURNAL OF ENDOUROLOGY Volume 28, Number 7, July 2014 ª Mary Ann Liebert, Inc. Pp. 814–818 DOI: 10.1089/end.2014.0069

Evaluation of a Novel Trocar-Site Closure and Comparison with a Standard Carter-Thomason Closure Device Michael del Junco, BA,* Zhamshid Okhunov,* Samuel Juncal, Renai Yoon, and Jaime Landman, MD

Abstract

Purpose: The aim of this study was to evaluate and compare a novel trocars-site closure device, the WECK EFx Endo Fascial Closure System (EFx) with the Carter-Thomason CloseSure System (CT) for the closure of laparoscopic trocar site defects created by a 12-mm dilating trocar. Methods: We created standardized laparoscopic trocars-site abdominal wall defects in cadaver models using a standard 12-mm laparoscopic dilating trocar. Trocar defects were closed in a randomized fashion using one of the two closure systems. We recorded time and number of attempts needed for complete defect closure. In addition, we recorded the ability to maintain pneumoperitoneum, endoscopic visualization, safety, security, and facility based on the surgeon’s subjective evaluations. We compared outcomes for the EFx and CT closure systems. Results: We created 72 standardized laparoscopic trocars-site abdominal wall defects. The mean time needed for complete defect closure was 98.53 seconds ( – 28.9) for the EFx compared with 133.61 seconds ( – 54.61) for the CT (P < 0.001). The mean number of attempts needed to achieve complete defect closure were 1.19 (1– 3) for the EFx and 1.19 (1–2) for the CT (P = 0.50). Mean scores for safety were 2.92 for EFx vs 2.19 for CT (P < 0.001). Mean scores for facility were 2.97 vs 1.83 for EFx and CT, respectively (P < 0.001). Mean scores for maintenance of pneumoperitoneum were 1.97 for EFx vs 2.33 for CT (P = 0.022). No significant difference was observed between the EFx and the CT systems for endoscopic visualization (2.28 vs 2.50, P = 0.080). Conclusions: In this in vitro cadaver trial, the EFx was superior in terms of time needed to complete defect closure, safety, and facility. CT was superior in terms of maintenance of pneumoperitoneum. Both systems were equal in the number of attempts needed to complete the defect closure and endoscopic visualization.

Introduction

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aparoscopic trocar site hernias (TSH) continue to be a source of morbidity with an incidence of 1% to 3%.1–3 TSH are significant, because they often necessitate surgical intervention for resolution. Known patient risk factors for TSH include advanced age, female sex, obesity, and wound infections. Technical factors such as larger trocar diameter and trocar design have also been shown to be associated with the occurrence of TSH.4–8 In addition, perioperative factors such as prolonged surgical procedure time with excessive trocar manipulation are significant contributors to an increased risk of TSH.3,8,9 Since the first reported TSH in 1968,10 continuous efforts have been made to reduce the risk by improving the efficacy, safety, and cosmetic effects of trocars-site closure methods. Various fascial closure systems have been developed and are currently used in clinical practice.11–14 The Carter-Thomason CloseSure System (CT) (CooperSurgical Inc., Trumbull, CT) is among the most commonly used fascial closure de-

vices in contemporary surgical practice. Limitations of the CT and its associated cost, however, have prompted surgeons to pursue improved alternatives. As such, we evaluated a novel system for fascial closure, the WECK EFx Endo Fascial Closure System (EFx) (Teleflex Medical, Research Triangle Park, NC). The EFx was introduced to facilitate the closure of 10 to15 mm trocars-site defects and, to date, research evaluating this novel trocars-site closure technique is scarce. The aim of this study was to evaluate and compare the EFx with the CT for the closure of laparoscopic trocar-site defects created by 12-mm dilating trocar-cannula systems in a cadaver model. Methods Study design

Institutional Review Board approval was gained to conduct the study. We evaluated and compared two fascial closure systems, EFx and CT n an in vitro evaluation using two

Department of Urology, University of California, Irvine. *Both authors contributed equally to this article.

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EVALUATION OF A NOVEL TROCAR-SITE CLOSURE

male cadaver torsos. The fresh frozen torsos were obtained from our institutional willed body program. We created pneumoperitoneum using a Veress needle and introduced a 10-mm laparoscopic camera via a standard trocar for direct endoscopic visualization. In each cadaver, we created 36 standardized 12-mm skin incisions in the abdomen. The incision size was measured using a digital caliper. After creation of the standardized incision, we deployed a 12-mm dilating Ethicon Endopath Xcel trocar-cannula system (Ethicon Endosurgery Inc., Cincinnati, OH) through each incision. The trocar insertion site was random, and each defect was separated by at least a 5-cm distance. After the insertion of each trocar-cannula system, we removed the obturator from the trocar, closed the stopcock valve, and confirmed the integrity of the pneumoperitoneum before beginning the experiment. We used a computer generated randomization list to randomize the closure devices for each defect. Under direct laparoscopic visualization, we closed 72 laparoscopic defects in a randomized manner—36 with the EFx and 36 with the CT. We confirmed proper trocars-site defect closure via laparoscopic visualization and direct manual palpation. Quantitative measurements

We measured and recorded the time needed for complete defect closure, and the number of attempts needed to close the defect properly was collected and compared between the two systems. The time (seconds) needed for complete defect closure was measured from the time the system first made contact with the skin until each respective suture was cut indicating complete closure was executed. Each closure attempt was recorded until complete and proper wound closure was executed. Qualitative measurements

The qualitative variables such as safety, security, and facility were rated according to Nakada and associates15 and categories of Below Average ( + ), Satisfactory (+ +) or Excellent (+ + +) were assigned. Safety. This was determined by any injuries to bowel, vessels, or other abdominal structures. This variable was evaluated during fascial closure, system insertion, and trocar closure under direct laparoscopic vision. Security. The security of each closure site was assessed for quality by manual and visual evaluation under endoscopic control for any closure defects or failures. In addition, presence or absence of air leakage was evaluated after each complete trocars-site closure. Facility. This was measured based on the need for any additional instrumentation during complete trocars-site closure in addition to the trocars-site closure systems and the suture. When necessary, auxiliary instrumentation and assistance were provided. All procedures were performed by two urologists with laparoscopic experience. Exhaustive practice was performed with each fascial closure system before the study experimental procedure. Each urologist performed a total of 36 randomly assigned laparoscopic trocars-site defects with the two devices.

815 Closure techniques EFx. The EFx is composed of two components (Figs. 1A, 1B): The tapered WECK EFx introducer and the suture passer. In this technique, the introducer and suture passer are manipulated by a single surgeon, which allows for singlesurgeon unassisted trocars-site closure. The EFx was inserted into the respective trocars-site defect in its closed and locked position (Fig. 1C). Next, while holding the device securely, the ring handle, located at the head of the device, is rotated to the unlocked position. Then the ring handle is pulled away from the device to fully open the two approximation wings located at the base of the device. The ring handle is rotated to the locked position to secure the approximation wings in the open position. The approximation wings are gently retracted to ensure that the wings are adjacent to the abdominal wall and perpendicular to the site defect (Fig. 1D). One end of a suture material is loaded into the notched portion of the suture passer, located above the needlepoint tip. The suture passer loaded with a suture material is inserted into the guide channel, located along the body of the device, and then through the silicone depth control pads of the approximation wings, located at the base of the device (Fig. 1E). The suture passer should be advanced until the black triangle located on the suture handle passer makes contact with the EFx introducer. Once the suture is passed on one side of the introducer, the suture passer is removed from the silicone control pads and guide channel. The opposite end of the existing suture is loaded into the notched portion of the suture passer, and the same process is repeated on the opposite side (Fig. 1F). Once the suture is passed on both sides, the loop of suture is removed from each guide channel, and the ring handle is rotated to the unlocked position (Fig. 1G). While holding the device securely, the ring handle is pushed into the EFx device to close the approximation wings. The ring handle is rotated to the locked position, and the device is removed completely from the trocars-site defect (Fig. 1H). The suture ends are removed from the silicone control pads, and standard knottying techniques are used to secure and close the trocar site defect (Fig. 1I). CT. This system, as described before, has two components: The cone-shaped pilot guide (5 mm and 10/12 mm) and the suture passer with recessed hinged jaw.13,14 For this study, we used the 10/12-mm pilot guide.12,13 The CT closure technique is started with the insertion of the pilot guide into the trocars-site defect. The guide holes located at the head of the pilot guide are oriented so that they are perpendicular to the defect. The hinged jaws of the suture passer are opened by pulling back on the thumb ring, and one end of a suture is loaded in the hinged jaw and then the thumb ring is released. Under direct visualization, the suture passer with attached suture is introduced through the pilot guide. After crossing the abdominal wall and peritoneum, the thumb ring is pulled back to release the suture, and the suture passer is retracted. With the hinged jaw closed, the suture passer is inserted through the opposite guide hole. The hinged jaw is then opened to grab the end of the indwelling suture material and pull through the pilot guide. Finally, the pilot guide is removed from the trocars-site defect, and the trocars-site defect is secured and closed with standard knot-tying techniques.

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FIG. 1. WECK EFx Endo Fascial Closure System. Used with permission. ª2013 Teleflex Medical.

Results

A total of 72 12-mm laparoscopic trocars-site defects were created and closed in two male cadaver models. There were no injuries to bowel, intra-abdominal vessels, or visceral organs noted during the study. The mean number of attempts needed to achieve complete fascial and peritoneal closure were 1.19 (range 1–3) for the EFx and 1.19 (range 1–2) for the CT (P = 0.50). The mean time needed for complete fascial and peritoneal closure was 98.53 seconds ( – 28.9) for EFx compared with 133.61 seconds ( – 54.61) for the CT (P < 0.001). The mean evaluation scores for maintenance of pneumoperitoneum, endoscopic visualization, safety, security, and facility were calculated from the surgeon’s subjective evaluations for each respective closure system. The EFx was subjectively rated as safer with the mean score of 2.92 compared with the CT with the mean score of 2.19, (P < 0.001). The EFx was rated significantly higher for facility with the mean score of 2.97 vs 1.83 for the CT, (P < 0.001). The EFx needed assistant or additional instruments only in 3% of trocar-site closures, whereas 77.8% of trocar-site closures requested assistance with additional instruments when CT was used (P < 0.001). The EFx was rated inferior, however, for the maintenance of pneumoperitoneum with the mean score of 1.97 vs 2.33 for the CT, (P = 0.022). There was no significant difference observed between the EFx and the CT systems for endoscopic visualization (2.28 vs 2.50, P = 0.080). Table 1 demonstrates the distribution of

average, satisfactory, and excellent scores for safety, air leakage, endoscopic visualization, facility, and number of attempts for two devices compared in this study. Discussion

Since its introduction, laparoscopic urologic surgery has evolved considerably to become a routine surgical practice.16 Trocar insertion is a prerequisite of laparoscopic surgery, and improper or incomplete fascial closure of the resulting trocars-site defect can lead to the development of trocar-site herniation. TSH are associated with significant complications including bowel or omentum incarceration and can have deleterious outcomes necessitating additional surgical interventions.1–3 A variety of trocar closure techniques and systems have been developed to facilitate proper fascial and peritoneal closure after laparoscopic procedures. In a comprehensive literature review of various techniques and devices used in the closure of trocars-site defects, we identified more than 16 original methods for trocar site closure.2,12,17–24 As a result, trocars-site closure systems such as the CT are conventionally used to facilitate the proper closure of fascial defects. Our study demonstrated that the trocars-site closure was achieved significantly faster when the EFx was used with the mean time of 1.6 minutes compared with 2.23 minutes for the CT. Moreover, 67% trocars-site defects were closed under its respective mean closure time (98.53 sec) with the EFx. In comparison, only 30% of trocars-site defects were closed

EVALUATION OF A NOVEL TROCAR-SITE CLOSURE

Table 1. Qualitative Breakdown of Port-Site Closure Systems WECK EFx Safety (mean, SD) Average (%) Satisfactory (%) Excellent (%) Air leakage (mean, SD) Average (%) Satisfactory (%) Excellent (%) Endoscopic visualization (mean, SD) Average (%) Satisfactory (%) Excellent (%) Facility (mean, SD) Average (%) Satisfactory (%) Excellent (%) Attempts (mean, SD) 1 (%) 2 (%) 3 (%)

CarterThomason

P value

2.92 ( – 0.368) 2.19 ( – 0.749) < 0.001 2.8 19.4 2.8 41.7 94.4 38.9 1.97 ( – 0.878) 2.33 ( – 0.862) 0.022 38.9 25.0 25.0 16.7 36.1 58.3 2.28 ( – 0.779) 2.50 ( – 0.655)

0.080

19.4 8.3 33.3 33.3 47.2 58.3 2.97 ( – 0.166) 1.83 ( – 0.775) < 0.001 0.0 2.8 97.2 1.19 (1–3)

38.9 38.9 22.2 1.19 (1–2)

86.1 8.33 5.56

80.6 19.4 0.0

0.500

SD = standard deviation.

under the same time when the CT technique was used. Similar results were demonstrated in a study performed by Nakada and colleagues,15 comparing five of the most commonly used methods for trocars-site closure. The study demonstrated that the standard hand-sutured method was the fastest and the CT system was the second in terms of time to complete the trocars-site closure. These findings were later confirmed in a randomized clinical study performed by Elashry and coworkers.12 In this study, the authors evaluated the closure of 95 12-mm trocarsite defects using one of eight randomly assigned trocar-site closure techniques including the standard hand-suture technique, the CT, Maciol suture needle, eXit Disposable Puncture Closure device, and other commonly used methods. Of those tested, the CT device had the second fastest mean closure time of 2.5 minutes with the range of 0.6 to 5 minutes with no intraoperative complications and success rate of 100%. In contrast, the standard hand closure technique had a significantly faster mean closure time of 1.9 minutes, superior to all other trocar closure techniques. The hand closure technique, however, was associated with a trocars-site complication rate of 50% and success in only 50% of patients. Trocar-site bleeding was the most common complication that occurred during this closure method. The safety profile is typically considered the most important factor to consider when evaluating any surgical equipment. During our study, there were no injuries to bowel, vessels, or underlying visceral organs observed in either techniques used. The EFx, however, was rated significantly

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higher for safety features. When the CT system is used for trocars-site closure, the suture passer is inserted into the pilot guide hole at a 45-degree angle and two holes are directed in the opposite direction, which creates significant lateral excursion of the suture passer. It makes it challenging to pick up the suture from the opposite side of the pilot guide when the suture passer is directed in the other direction and its movement is significantly limited. This often necessitates using additional instruments or deeper insertion of the suture passer, which potentially increases the risk of intra-abdominal injuries and adds to the operative time. Seventy-eight percent of trocar closures with the CT necessitated the use of additional instruments, with an assistant needed to grasp the suture and pass it to the CT device. In contrast, the EFx uses a simplified approach to pass the two ends of the suture through the silicone control pads, close the approximation wings, and completely remove the device. When using the EFx, the ring handle, which is responsible for locking and unlocking the system and approximation wings, is not immediately intuitive, but has a short learning curve. The EFx system allows a single surgeon to be self-sufficient, and in the current study, only 2.8% percent of trocars-site closures using the EFx needed additional instruments and assistance. Despite the short learning curve associated with the novel EFx technique, there was no difference in the mean number of attempts to achieve proper trocars-site closure between the two systems. Both the EFx and the CT produced precise and secure trocars-site closures, demonstrating no significant difference in the surgeon’s evaluation of endoscopic visualization of facial closures. In the current study, we demonstrated that the CT was rated superior in security and air leakage compared with the EFx. Similarly, Nakada and colleagues15 in an in vitro study demonstrated that the CT system was the most efficient in terms of closure security and air-leakage compared with four other methods evaluated in the study. Elashry and coworkers12 also confirmed these findings in a clinical setting with a group of patients who underwent different laparoscopic surgeries. Clinical evaluation will be needed to determine whether there is any clinical difference between the two devices with regard to the quality of the closure created. Cost is of increasing importance in healthcare delivery. With regard to the direct University of California, Irvine price, a single CT device ranges in price from approximately $100 to $233 for the CT and the CTXL, respectively. In comparison, a single EFx device retails at approximately $100. These prices do not represent the national average sales price of each device. The purchase price of each respective trocar closure system, however, should not be the only consideration when selecting a trocars-site closure system. The trocar closure system must also be easy-to-use, safe, and efficient and produce proper fascial and peritoneal closure, for which the device is designed. The principal limitation of this study was its in vitro design. Although this study was conducted in a laboratory setting, we used fresh frozen cadaver models to simulate the live human tissue as close as possible, which enables us to apply these definitive conclusions in the clinical setting. Further prospective randomized clinical evaluations with longer follow-up protocols are needed to assess the outcomes that both the EFx and CT will have on the development of TSH.

818 Conclusions

Both the EFx and CT devices provided proper and reproducible fascial and peritoneal closure of laparoscopic trocarssite defects created by 12-mm dilating trocar-cannula systems. The EFx system was superior to CT in terms of time, facility, cost, and safety profile. The CT provided excellent and secure fascial closures with significantly less air leakage. Prospective clinical trials are needed to confirm these findings. Future comparative evaluations of the EFx with the CT in a clinical setting should be performed to confirm our findings. Disclosure Statement

The study was supported by Teleflex Medical. For the authors, no competing financial interests exist. References

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14. Spalding SC, Ponsky TA, Oristian E. A new Dual-hemostat technique to facilitate the closure of small laparoscopic trocar incisions. Surg Endosc 2003;17:164–165. 15. Nakada SY, McDougall EM, Gardner SM, et al. Comparison of newer laparoscopic port closure techniques in the porcine model. J Endourol 1995;9:397–401. 16. Kavoussi LR, Kerbl K, Capelouto CC, et al. Laparoscopic nephrectomy for renal neoplasms. Urology 1993;42: 603–609. 17. Chapman WH 3rd. Trocar site closure: A new and easy technique. J Laparoendosc Adv Surg Tech A 1999;9:499–502. 18. Chatzipapas IK, Hart RJ, Magos A. Simple technique for rectus sheath closure after laparoscopic surgery using straight needles, with review of the literature. J Laparoendosc Adv Surg Tech A 1999;9:205–209. 19. Conlon KC, Curtin J. A simple technique for the closure of laparoscopic trocar wounds. J Am Coll Surg 1995;181: 565–566. 20. Durkin DJ, Horner J. Further modification of the dualhemostat port closure technique. Surg Endosc 2005;19: 1002. 21. Earle DB. A simple and inexpensive technique for closing trocar sites and grasping sutures. J Laparoendosc Adv Surg Tech A 1999;9:81–85. 22. Farina Perez LA, Zungri Telo E. [Closure of laparoscopic access ports using a Reverdin needle: A new use for an old instrument]. (Spa) Actas Urol Esp 2003;27:168–169. 23. Fasolino A, Colarieti G, Fasolino MC, Pastore E. [The use of Foley’s catheter and suturing to control abdominal wall haemorrhage provoked by the trochar. Comparative study]. (Ita) Minerva Ginecol 2002;54:443–445. 24. Jones JL, Thompson RJ, Benrubi GI. Suture placement for hemostasis during laparoscopy using the Stamey needle. J Am Assoc Gynecol Laparosc 1995;2:445–447.

Address correspondence to: Jaime Landman, MD Department of Urology University of California, Irvine 333 City Boulevard West, Suite 2100 Orange, CA 92868 E-mail: [email protected]

Abbreviations Used CT ¼ Carter-Thomason CloseSure System EFx ¼ WECK EFx Endo Fascial Closure System TSH ¼ trocar-site hernia

Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device.

The aim of this study was to evaluate and compare a novel trocars-site closure device, the WECK EFx™ Endo Fascial Closure System (EFx) with the Carter...
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