Lap Pak for Abdominal Retraction

New Technology Review

New TechNology Review Lap Pak for Abdominal Retraction Ganesh Sivarajan, MD,1 Sam S. Chang, MD, FACS,2 Amr Fergany, MD, PhD,3 S. Bruce Malkowicz, MD,4 Gary D. Steinberg, MD,5 Herbert Lepor, MD1 1 New York University School of Medicine, New York, NY; 2Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, TN; 3Sections of Oncology, Laparoscopy and Robotics, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH; 4University of Pennsylvania Health System, Philadelphia, PA; 5 Section of Urology, University of Chicago Medical Center, Chicago, IL Retraction of the bowels during abdominal surgery is generally facilitated by the use of a combination of various retractors along with surgical towels or sponges. The use of surgical towels and sponges may lead to retained foreign bodies or adhesions. In addition, these towels and sponges often require manipulation during long surgical procedures. The ideal way to avoid these problems in abdominal surgery is to develop a technique for retraction of the abdominal contents that eliminates the requirement for these foreign bodies. This article presents the results of a small trial for Lap Pak (Seguro Surgical, Columbia, MD), a disposable radio-opaque device that is made of silicone and retracts the bowels in a cephalad orientation without the need for towels or sponges. [ Rev Urol. 2012;14(3/4):41-47 doi: 10.3909/riu0572] ® © 2013 MedReviews , LLC KEY WORDS Retraction • Postoperative adhesions • Retained foreign bodies • Lap Pak R etraction of the bowels during abdominal surgery is generally facilitated by the use of a combination of various retractors along with surgical towels or sponges. In order to maintain exposure during cases of longer duration, these sponges and towels often require frequent intraoperative manipulations and adjustments.1 Although effective, this technique carries certain risks. Specifically, the liberal use of surgical sponges and towels confers an inherent risk of foreign body retention and the formation of postoperative adhesions. A technique for abdominal retraction that eliminates towels and sponges has the potential to decrease the risk of a retained foreign body and trauma to the intestines, as well as shorten operative time. Vol. 14 No. 3/4 • 2012 • Reviews in Urology • 41 40041700002_RiU0572.indd 41 12/02/13 2:27 PM Lap Pak for Abdominal Retraction continued Retained Foreign Bodies Retained sponges and towels during abdominal surgery are avoidable causes of significant postoperative morbidity, including bowel obstruction, perforation, sepsis, reoperations, and even death.2,3 In addition be delayed for several months or even years before detection occurs secondary to a late complication.7 A recent retrospective case series reported that the time from causative operation to identification of the retained foreign body ranged The surgical sponge is the most frequently encountered retained foreign body overall, and the abdomen and pelvis are the most common sites of retention. to these potential harms, instances of retained foreign bodies have significant medicolegal consequences for surgeons and health care institutions.4,5 The surgical sponge is the most frequently encountered retained foreign body overall, and the abdomen and pelvis are the most common sites of retention.3,4 The frequency of this grave medical error has been estimated to be between 0.3 and 1.0 of every 1000 abdominal operations and 1 in every 8000 to 18,000 inpatient surgeries overall. There is evidence that these reported incidences in the literature may even represent an underestimation secondary to underreporting.3,6-8 For example, the Mayo Clinic (Rochester, MN), a high-volume tertiary surgical referral institution that performs routine postprocedure radiography, reported a true rate of 1 in 5500 operations.9 It is disconcerting that this adverse event continues to occur at a measurable rate despite widespread adoption of stringent protocols regarding the proper tracking and counting of sponges, needles, and instruments. In fact, a recent retrospective, casecontrol study suggested that greater than 1500 instances of retained foreign bodies occur annually in the United States.3 Although the complications associated with these events frequently arise acutely in the early postoperative period, discovery of the foreign body can in some instances from 3 days to 40 years.10 The most common symptoms associated with retained foreign bodies in the abdomen are pain and intestinal obstruction.5,10 In the acute setting, identification often occurs as a result of pain symptoms, bowel obstruction, ileus, or infectious complications.4,11 More delayed presentation can be prompted by the development of fistulae or a mass mimicking a tumor.4,12 In addition to the abovementioned medical complications, to the $579,079 spent on defense costs. Mean and median payments for abdominal cases were $32,500 and $68,857, respectively.14 The occurrence of medical errors such as these often invites unfavorable media attention3 that can impart a significant embarrassment for both institution and surgeon. Several independent risk factors associated with retained surgical foreign bodies have been identified in the literature. Specifically, the risk appears to be greater in surgeries involving an unexpected change intraoperatively, operations involving more than one surgical team, and prolonged or emergent surgeries. Greater body mass index (BMI) has also been associated with greater likelihood of retained foreign bodies.3,4,15 Additional postulated risk factors include the use of small sponges as well as operations in which large numbers of instruments and/or sponges are The most common symptoms associated with retained foreign bodies in the abdomen are pain and intestinal obstruction. In the acute setting, identification often occurs as a result of pain symptoms, bowel obstruction, ileus, or infectious complications. retained foreign bodies result in considerable cost burden on the health care system. With respect to medical costs, the average Medicare payment for an admission related to a retained foreign body has been reported to exceed $60,000. The Affordable Care Act specifically states that surgeries related to foreign bodies are not reimbursable. Furthermore, institutional costs are often surpassed by the medicolegal costs associated with resulting litigation, which have been estimated to average $150,000 or more per case.13 A recent review of closed malpractice claims found that 40 instances of retained foreign bodies generated a total of $2,072,319 in indemnity payments in addition used.4-5,16 Radical cystectomy for invasive bladder cancer fits many of these criteria for retention of surgical foreign bodies. Unfortunately, these errors have been demonstrated to occur even in instances in which instrument and sponge counts, confirmatory radiographs, and radiofrequency tagging were employed.15 The goal of achieving a zero incidence of this potentially catastrophic adverse event will not be realized with strategies aimed simply at identifying these retained foreign bodies prior to completion of the procedure. The most reliable way to eliminate the risk of retained towels or sponges during intra-abdominal procedures is to eliminate their use. 42 • Vol. 14 No. 3/4 • 2012 • Reviews in Urology 40041700002_RiU0572.indd 42 12/02/13 2:27 PM Lap Pak for Abdominal Retraction Postoperative Adhesions Although the risk of retained foreign bodies is certainly concerning on its own, the widespread use of surgical sponges and towels to aid in bowel retraction during abdominal surgery carries the additional potential risk of increased postoperative intra-abdominal adhesion formation. Postoperative adhesions, often defined as the development of abnormal fibrous unions between tissues, are estimated to occur in 93% of patients who have undergone laparotomy and in up to 97% of patients after open pelvic Intra-abdominal procedures.17-22 adhesions causing significant postoperative morbidity occur in approximately 5% of these intraabdominal cases. Intra-abdominal adhesions have been implicated as a frequent cause of small-bowel obstruction, female infertility, chronic pelvic or abdominal pain, and the need for potentially difficult reoperations.23-27 It has been reported that 1% of all surgical admissions and 3% of all laparotomies occur as a direct result of adhesion-related intestinal obstructions.17 Between 49% and 74% of all small bowel obstructions are caused by postoperative adhesions.24,27,28 The annual health care costs associated with managing these intestinal obstructions exceed $3.4 billion.29 Although adhesions typically form within 3 days of abdominal surgery, maximal concentration occurs between 10 and 14 days postoperatively.19 Although approximately 39% of these symptomatic obstructions occur within 1 year of surgery, more than 20% present more than 10 years postoperatively.24 Thus, it is generally accepted that the formation of postoperative adhesions confers an increased lifetime risk of bowel obstruction. Postoperative adhesion formation is widely believed to be the result of peritoneal injury. This process is thought to be exacerbated by a variety of potential intraoperative insults including mechanical trauma, foreign-body interactions, desiccation, and chemical, allergic, or ischemic injury.30 Despite decades of advancements in surgical technique and the adoption of numerous intraoperative measures specifically designed to minimize adhesion formation, little progress has been made in decreasing the incidence of adhesion development or its resultant consequences.23,31,32 One common etiology of mechanical trauma to the bowel is the manipulation and retraction of intra-abdominal structures by surgical sponges, gauze, and towels. This trauma is believed to arise by at least two specific mechanisms: direct mucosal or serosal abrasion and retained remnant fibers left behind after removal of the surgical sponges, gauze, and towels. There is compelling experimental and clinical evidence linking both of these etiologies to the increased formation of adhesions.29,33-35 Clear evidence of the role of these foreign bodies in adhesion formation can be seen in the crosssectional, multi-institutional study that reported that 26% of patients with adhesions had evidence of associated foreign body granulomas on examination.36 It has also been demonstrated in several animal models that the use of less abrasive gauze, silicone, or foamcomposite material may, in fact, result in the formation of fewer postsurgical adhesions.1,33,35 Consequently, it has been postulated that limiting the use of surgical sponges and towels that are abrasive or known to leave behind foreign fibers or lint may help prevent the formation of adhesions after abdominal or pelvic surgery. Alternative strategies for bowel retraction need to be identified in order to replace the use of surgical towels and sponges. An additional avenue of research has focused on the use of antiadhesive agents that could serve as a barrier to prevent adjacent structures from being linked by forming adhesive bands.23 Although several of these agents have shown some promise in preventing adhesions,37-43 results have often been conflicting and none have been able to demonstrate an ability to reduce the frequency of adverse clinical outcomes such as small-bowel obstruction, infertility, or pain in a randomized, controlled trial.23,44-46 Lap Pak The ideal way to avoid the aforementioned problems attributed to sponges and towels in abdominal surgery is to develop a technique for retraction of the abdominal contents that eliminates the requirement for these foreign bodies. Lap Pak (Seguro Surgical, Columbia, MD) is a disposable radio-opaque device that is made of silicone and retracts the bowels in a cephalad orientation without the need for towels or sponges (Figure 1). The device is malleable and has an inverted U cutout that accommodates the root of the mesentery and the sigmoid colon. The inert and atraumatic surfaces of Lap Pak are in direct contact with the intestinal contents. The barrier-like device is secured in place using retractor blades. Initial experience suggests that Lap Pak is easiest to use with a table-mounted Bookwalter RetractorTM (Symmetry Surgical, Nashville, TN) or a table-mounted Bookler RetractorTM (Mediflex Surgical Products, Islip, NY). With experience, Lap Pak also has been successfully used with a Balfour Vol. 14 No. 3/4 • 2012 • Reviews in Urology • 43 40041700002_RiU0572.indd 43 12/02/13 2:27 PM Lap Pak for Abdominal Retraction continued Figure 1. Lap Pak (Seguro Surgical, Columbia, MD). retractor. Another potential advantage of Lap Pak is that it minimizes temperature exchange between the intestinal cavity and ambient environment of the operating room, which helps to maintain the intestinal cavity at near normal body temperature. Initial Experience With Lap Pak Five high-volume urologic oncology surgeons affiliated with The Lahey Clinic (Burlington, MA), the Hospital of the University of Pennsylvania (Philadelphia, PA) Vanderbilt University Medical Center (Nashville, TN), Cleveland Clinic (Celeveland, OH), and the University of Chicago (Chicago, IL) agreed to test Lap Pak during radical cystectomies and urinary diversion. Prior to using the device, all surgeons had the opportunity to discuss its use with the engineer who developed the device. The surgeons agreed to use the device on five cases. After completing the five cases, the surgeons were invited to complete a survey designed to capture several features of the device and its utility. Several of the surgeons completed the survey prior to a scheduled teleconference. Others completed the questionnaire during the teleconference. The responses to the Lap Pak survey are summarized in Table 1. The theoretical advantage of Lap Pak is to reduce the risk of retained foreign bodies (sponges, towels) and to minimize trauma to the bowel secondary to abdominal packing with sponges or towels. One of the goals of the survey was to determine whether a group of experienced urologic oncology surgeons believed these were legitimate clinical opportunities of the device. Four (80%) of the surgeons evaluating the device thought that the potential for decreasing retained foreign bodies in the abdomen was a potential advantage of Lap Pak and three surgeons (60%) indicated TABLE 1 Responses to Lap Pak Survey Do you feel that decreasing the risk of leaving a foreign body in the abdominal cavity is a significant advantage of Lap Pak? Yes 4 (80%) No 1 (20%) Do you feel that decreasing trauma to the bowel elicited by towels or lap pads is a significant potential advantage of Lap Pak? Yes 3 (60%) No 2 (40%) What is your overall impression of Lap Pak? Favorable 3 (60%) Neutral 2 (40%) Unfavorable 0 Approximately what percentage of cases did Lap Pak work effectively? 0 0 20% 2 (40%) 40% 0 60% 1 (20%) 80% 0 100% 2 (40%) What was your impression of the impact of Lap Pak on the bowel (edema/abrasions) relative to packing with towels or lap pads? Improved 3 (60%) No difference 2 (40%) Worse 0 Would you routinely use Lap Pak for future cases requiring abdominal packing? Yes 3 (60%) No 2 (40%) 44 • Vol. 14 No. 3/4 • 2012 • Reviews in Urology 40041700002_RiU0572.indd 44 12/02/13 2:27 PM Lap Pak for Abdominal Retraction that decreasing trauma to the bowel was a legitimate advantage. The three surgeons who expressed the opinion that Lap Pak offered the potential for decreasing trauma to the bowel actually reported less bowel trauma associated with the use of Lap Pak. A second objective was to assess the performance of Lap Pak. Overall, three of the surgeons (60%) had an overall favorable impression of Lap Pak in terms of its performance during radical cystectomies. Two of the surgeons (40%) had a neutral impression of Lap Pak and none of the surgeons expressed a negative impression. Three of the surgeons indicated they would use the current version of Lap Pak on all future abdominal cases that required abdominal packing. Overall, Lap Pak provided effective retraction of the abdominal contents in 75% of all cases investigated by the surgeons. The surgeons who did not have a favorable impression of Lap Pak used a Balfour retractor for exposure. It was also reported that the device was slightly more cumbersome to position in patients with very low and very high BMIs. The relationship between ease of use and BMI was not universally observed. Discussion There is compelling evidence in laboratory animals that direct contact between the intestines and towels or sponges during surgical procedures is a source of iatrogenic injury to the bowel. Furthermore, retained towels and sponges during abdominal surgery results in serious postoperative morbidity and potential mortality and risks the reputation of the surgeon and institution. Lap Pak was developed with the intent of decreasing these known consequences of sponges and towels when used for facilitating surgical exposure during major abdominal surgery. Radical cystectomy with pelvic lymphadenectomy and urinary diversion is a major abdominal surgical procedure that requires cephalad packing of the abdominal content in order to gain access to the bladder and retroperitoneum. For this review, five high-volume urologic oncology surgeons were invited to participate in the first testing of Lap Pak. The surgeons agreed to perform five radical cystectomies using the device without any prior training sessions. Prior to the first procedure, the technique for intraoperative placement retractor. The Balfour retractor has a single blade for cephalad exposure which may not be adequate to hold Lap Pak securely in place. Those surgeons using retractors that had two cephalad-oriented limbs all thought Lap Pak facilitated exposure and were both willing and enthusiastic about using the device on future cases. At the moment, Lap Pak comes in only one size primarily because of the limited variability in the dimensions of the adult abdominal cavity. Based on preliminary experience, additional sizes may be required for patients at the extremes of BMI. At the moment, Lap Pak comes in only one size primarily because of the limited variability in the dimensions of the adult abdominal cavity. Based on preliminary experience, additional sizes may be required for patients at the extremes of BMI. of the device was reviewed with the engineer who developed the device. Of the five surgeons investigating Lap Pak, four (80%) and three (60%) agreed with the premise that decreasing the risk of retained foreign body and minimizing trauma to the bowel was a clinically significant potential benefit of Lap Pak, respectively. Overall, three surgeons (60%) had a favorable experience using Lap Pak. None of the surgeons had a negative impression of the device and two (40%) had a neutral impression. Overall, Lap Pak was used in 23 cases. Of these cases, Lap Pak successfully facilitated exposure in 14 cases (61%). Three (60%) of the surgeons indicated they would use Lap Pak routinely on future radical cystectomy procedures. Two of the five surgeons were less enthusiastic about the potential benefits or the performance of the device. These surgeons used Lap Pak together with a Balfour We recognize that we cannot overgeneralize based on the view of only five surgeons whose experience may differ based on their level of expertise. Nevertheless, the generally favorable initial experience with Lap Pak provides the basis for further investigation of the device in order to optimize its use. It is likely that with further experience, minor adjustments will be made in the design or additional sizes will be required for its more universal role in abdominal surgery. This pilot experience with Lap Pak suggests that the device should not be initially used with a Balfour retractor. Conclusions The majority of surgeons we surveyed had a favorable experience with Lap Pak, and none had a negative impression. Overall, Lap Pak provided an effective method of retaining the bowels for radical cystectomies with pelvic lymphadenectomy and urinary diversions. There was a strong conviction Vol. 14 No. 3/4 • 2012 • Reviews in Urology • 45 40041700002_RiU0572.indd 45 12/02/13 2:27 PM Lap Pak for Abdominal Retraction continued among the surgeons who used Lap Pak that its characteristics had the potential to reduce the risk of retained foreign bodies and most believed that eliminating the use of towels for bowel packing resulted in fewer traumas to the bowels. 12. References 14. 1. 15. 2. 3. 4. 5. 6. 7. 8. 9. 10. Liu BG, Ruben DS, Renz W, et al. Comparison of peritoneal adhesion formation in bowel retraction by cotton towels versus the silicone lap pak device in a rabbit model. Eplasty. 2011;11:e42. Gonzalez-Ojeda A, Rodriguez-Alcantar DA, ArenasMarquez H, et al. Retained foreign bodies following intra-abdominal surgery. Hepatogastroenterology. 1999;46:808-812. Gawande AA, Studdert DM, Orav EJ, et al. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003;348:229-235. Stawicki SP, Evans DC, Cipolla J, et al. 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A technique for abdominal retraction that eliminates towels and sponges has the potential to decrease the risk of a retained foreign body and trauma to the intestines, as well as shorten operative time. • Retained sponges and towels during abdominal surgery are avoidable causes of significant postoperative morbidity, including bowel obstruction, perforation, sepsis, reoperations, and even death. • Lap Pak (Seguro Surgical, Columbia, MD) is a disposable radio-opaque device made of silicone used to retract the bowels in a cephalad orientation without the need for towels or sponges. The device is malleable and has an inverted U cutout that accommodates the root of the mesentery and the sigmoid colon. • The surgeons surveyed for this review had a favorable experience with Lap Pak, and none had a negative impression. Its use provided an effective method of retaining the bowels for radical cystectomies with pelvic lymphadenectomy and urinary diversions. It has the potential to reduce the risk of retained foreign bodies. 46 • Vol. 14 No. 3/4 • 2012 • Reviews in Urology 40041700002_RiU0572.indd 46 12/02/13 2:27 PM Lap Pak for Abdominal Retraction 39. 40. 41. tissue plasminogen activator. Ann R Coll Surg Engl. 1994;76:412-415. Sahin Y, Saglam A. Synergistic effects of carboxymethylcellulose and low molecular weight heparin in reducing adhesion formation in the rat uterine horn model. Acta Obstet Gynecol Scand. 1994;73:70-73. Fazio VW, Cohen Z, Fleshman JW, et al. Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection. Dis Colon Rectum. 2006;49:1-11. Farquhar C, Vandekerckhove P, Watson A, et al. Barrier agents for preventing adhesions after 42. 43. surgery for subfertility. Cochrane Database Syst Rev. 2000;(2):CD000475. Becker JM, Dayton MT, Fazio VW, et al. 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Vol. 14 No. 3/4 • 2012 • Reviews in Urology • 47 40041700002_RiU0572.indd 47 12/02/13 2:27 PM