Balloon Blunt-Tip Trocar for Laparoscopic Cholecystectomy: Improvement over the Traditional Hasson and Veress Needle Methods

Transcription

1 JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES Volume 11, Number 2, 2001 Mary Ann Liebert, Inc. Balloon Blunt-Tip Trocar for Laparoscopic Cholecystectomy: Improvement over the Traditional Hasson and Veress Needle Methods THOMAS R. BERNIK, M.D., 1 SUSAN M. TROCCIOLA, M.D., 1 DAVID A. MAYER, M.D., 2 JOSEPH PATANE, M.D., 1 CHRISTOPHER J. CZURA, M.S., 1 and MARC K. WALLACK, M.D. 1 ABSTRACT Background and Purpose: Laparoscopic cholecystectomy (LC) is a routine procedure for most general surgeons, yet the technical aspects of gaining access to the peritoneal cavity continue to be quite diverse. We describe a prospective review of 180 LCs using three access techniques: open balloon blunt-tip trocar (BBTT), open Hasson (HA), and closed Veress needle (VN). We favor the BBTT because it is designed to avoid all sharp instrumentation and offers superior seal and mobility, as well as expeditious and easy abdominal access. Patients and Methods: The techniques and devices were evaluated prospectively with regard to simplicity of access, leakage of carbon dioxide, access time, and complications. All patients underwent LC by one of two Board-certified surgeons. Results: The mean time to insertion of the laparoscope for the BBTT ( minutes) was significantly less than the insertion time for the VN technique ( minutes, P, 0.05). The insertion time for the BBTT was also less than for the standard HA approach ( minutes; P, 0.05). There were no visceral or vascular injuries noted, but CO 2 leakage and subcutaneous insufflation of gas experienced in the standard HA and VN groups resulted in lengthened operative times. One patient in the BBTT group experienced a postoperative port-site herniation, which was repaired primarily without consequence. Conclusion: The BBTT is an established, safe alternative to blind access for LC. Our technique is simple and rapid and avoids most of the technical difficulties encountered by other open access devices. We believe this method provides surgeons with an option that is efficient and easier to perform than most other conventional open-access laparoscopic techniques. INTRODUCTION IN RECENT YEARS, laparoscopy has become the preferred technique for many surgical procedures. Surgeons continually attempt to maximize efficiency while maintaining high standards of safety. Access to the abdomen is the initial operative step in laparoscopic abdominal surgery. Because of the wide variability in techniques as well as safety, laparoscopic abdominal access has been a topic of debate since the first documented laparoscopic procedures. Pneumoperitoneum may be established either via a closed or an open method. The closed method, 1 Department of Surgery, Saint Vincents Hospital, New York, New York. 2 Department of Surgery, Huntington Hospital, Huntington, New York. 73

2 74 BERNIK ET AL. FIG. 1. Blunt-tip trocar with balloon inflated and external sponge collar. (Veress needle; VN) is used in approximately 97% of all laparoscopic procedures, with only 3% being performed by the open technique. 1 The presumed reasons for this discrepancy lie in the belief that the closed system is fast and easy to use. The perception that closed access is simpler and faster is currently being challenged. At present, surgeons use a wide variety of disposable and nondisposable instruments and have developed numerous variations to the commonly used open Hasson access (HA) method. 2,3 In this article, we describe a modified version of the open technique using a blunt trocar that allows safe, controlled access without leakage of pneumoperitoneal gas or lengthening of operative time. We prospectively compare the balloon blunt-tip trocar (BBTT), HA, and VN methods for obtaining laparoscopic abdominal access. Patients PATIENTS AND METHODS Between December 1996 and September 1999, 180 patients underwent elective or semielective laparoscopic cholecystectomy (LC), during which abdominal access was obtained using one of three methods. The patients were randomized to one of three groups: in Group I (N 5 118), a BBTT and balloon cuff (10-mm Blunt Tip Surgical Trocar; U.S. Surgical Norwalk, CT) was employed. The trocar has a blunt-tip obturator with an internal balloon (Fig. 1) that assures an airtight peritoneal seal and stable sleeve positioning (Fig. 2). An external sponge collar seals the abdominal wall and provides additional trocar stability, as well as sustained pneumoperitoneum. Patients in Group II (N 5 34) underwent a standard HA FIG. 2. Intra-abdominal view of balloon peritoneal seal.

3 BLUNT-TIP TROCAR FOR CHOLECYSTECTOMY 75 TABLE 1. DEMOGRAPHICS OF PATIENTS ACCORDING TO ACCESS METHOD method with a 10-mm Blunt Port Trocar and fascial sutures. Abdominal access for Group III (N 5 28) was achieved with a VN (Surgineedle 120 mm), followed by Versaport 10-mm Trocar (U.S. Surgical) insertion. The Visiport optical trocar was not evaluated in this series. Of 180 patients, 133 were women and 47 were men (Table 1). Among these patients, 12% were considered obese, with a body mass index (BMI) Obese patients were not subclassified as to degree of obesity. Sixteen percent of the patients had previous abdominal surgery, with nine patients having a midline laparotomy incision. The time of insertion was recorded as the time from skin incision to the placement of the laparoscope in the abdominal cavity. The overall operative time (time of skin incision to skin closure), total hospital stay, and postoperative hospital stay were noted. Patients considered obese were reviewed with respect to the difficulty of gaining assess and time to abdominal access. All postoperative complications were recorded. Statistical analysis was performed using Student s t-test. Description of Procedure Group I Group II Group III (BBTT) (HA) (VN) (N 5 118) (N 5 34) (N 5 28) M/F 24/94 14/20 9/19 Mean age Male Female Obese Previous abdominal surgery All patients underwent general endotracheal intubation. Patients in the early series were regularly catheterized prior to surgical intervention. It later became apparent that Foley catheterization for blunt-tip trocar laparoscopy was optional, as no sharp instrumentation was being used. Omission of the catheter decreased the potential for urinary infection or other catheter-related complications. Patients were encouraged to void preoperatively. In Groups I and II, a 15- to 20-mm vertical or horizontal incision was made infraumbilically or supraumbilically, as dictated by previous surgery. Subcutaneous tissues were spread using S retractors until the fascia was visible. Kocher clamps were applied to the fascia bilaterally. The abdominal wall was elevated, and a 6- to 8-mm vertical incision was made with a scalpel in the linea alba. Crile artery forceps were then used to bluntly puncture the peritoneum. The peritoneal opening was probed manually to ensure that there were no adhesions to the anterior abdominal wall. For Group I patients, the blunt-tip trocar was then inserted and the balloon inflated with 30 cc of air. With gentle traction on the balloon, the external sponge was pressed firmly against the anterior abdominal wall, ensuring a tight pneumoperitoneal seal. The external sponge was snapped in place and locked in position. In Group II patients, the abdominal wall was elevated with Kocher clamps. Bilateral full-thickness fascial sutures were placed and secured to the trocar. The gas source was attached and CO 2 insufflated into the peritoneal cavity. The blunt trocar was removed and the laparoscope passed into the sleeve, determining proper intraperitoneal placement. For Group III patients, the fascia was exposed in a similar fashion. The Veress needle was introduced into the abdominal cavity and confirmed by a saline gravity flow test. Following insufflation of CO 2, the Veress needle was removed and the sharp 10-mm trocar inserted. On completion of all laparoscopic procedures, the fascia in both 10-mm ports was closed using absorbable suture in interrupted figure-of-eight fashion. RESULTS The mean operative time for all patients was 59 minutes (men 57 minutes; women 60 minutes) and was shortest in Group I (Table 2). The mean access time, or time from incision to insertion of the laparoscope, for all groups was seconds (range seconds) and was shortest for Group I. There was a significant difference observed in the time to abdominal access between the BBTT group and the HA and VN groups (P, 0.05). Seven patients required supraumbilical access because of infraumbilical scarring, with no significant difference in access time. Five patients required conversion to an open cholecystectomy because of inability to remove the gallbladder safely laparoscopically. These patients were included in the study because initial abdominal access in TABLE 2. ACCESS AND OPERATIVE TIMES AND HOSPITAL STAY ACCORDING TO TYPE OF ACCESS Group I Group II Group III Access time (sec) (mean 6 SD) Mean operative time (min) 2. Total hospital stay (days) Postop stay (days)

4 76 BERNIK ET AL. all five patients was achieved laparoscopically. Six patients underwent laparoscopic cholangiograms with three open common bile duct explorations. Full pneumoperitoneum was established and maintained in all Group I cases, with no instances of CO 2 leakage. Two patients in Group II experienced CO 2 leakage, necessitating approximation of the skin with a towel clamp. The leakage was secondary to trocar sleeve displacement in one patient and an inadequate fascial seal in the other. Both patients were obese. One patient in this group developed moderate, but self-limited, subcutaneous abdominal wall emphysema. In Group III, three patients developed self-limited subcutaneous emphysema necessitating Veress needle repositioning. For the patients who experienced leakage of CO 2, one of whom was obese, the insertion time was lengthened by an average of 23 seconds. Obesity prolonged the time needed for abdominal exposure in all groups by a mean of seconds, with no statistically significant difference between the groups. The obese patients were included in the overall mean access times. The total hospital stay for all patients was an average of 2.2 days, and the mean post-operative hospital stay was 1.5 days (Table 2). There were no significant differences in the length of stay of the three groups. One Group I patient required reoperation for postoperative infraumbilical port-site herniation. The herniation was repaired without incident on postoperative day 2, and the patient was discharged the same day. There were no other operative or perioperative morbidities. DISCUSSION Even though most current literature favors the open access technique because of a presumed increase in safety, there has been little documentation with regard to its efficiency and access time compared with the VN method. Furthermore, few authors have commented on the technical aspects of each procedure and whether these presumed technical advantages or disadvantages balance the increased or decreased risks in safety. Throughout the evolution of laparoscopic access, the closed VN approach persists as the technique of choice for most surgeons, primarily for practical reasons: simplicity and speed. This choice probably reflects the misconception that the alternative open access methods are difficult, necessitate suturing to maintain a pneumoperitoneal seal, require extra hardware, and are more time consuming. We find none of these assumptions to be true. In fact, in our experience, the open technique eliminates the sometimes lengthy process of confirming accurate placement of the VN, as well as the need for establishing complete pneumoperitoneum before laparoscope insertion. With regard to access time, several series have reported favorable results when comparing the closed and open methods. Ohl and associates 5 report an entry time of 149 seconds using the open technique compared with 354 seconds in a VN series reported by Byron and colleagues. 6 Our recorded access time for the BBTT was seconds compared with seconds using the VN approach (P, 0.05). Both the BBTT and the HA abdominal access methods proved to be considerably faster than the VN in our series. This result is in direct contrast to the longstanding belief that VN access is less time consuming than the open techniques. Blunt trocar access laparoscopy is a variation on the open technique first introduced by Hasson in 1971, 2 and over time, it has proved to be one of the safest access techniques for all forms of laparoscopy. The use of blunttip trocars confers several advantages, including absence of sharp instrumentation and the need for blind access to the peritoneum. Since its introduction, there have been many modifications to the Hasson trocar, which have made the open technique simple and rapid. There are a large variety of disposable and nondisposable blunt-tip trocars available. Most require anchoring sutures into the abdominal wall fascia followed by incision of the linea alba and placement of a trocar. The primary disadvantage of this technique is the lack of stability of the trocar sleeve, possibly leading to leakage of CO 2 with loss of pneumoperitoneum or to displacement of the sleeve. The frequent leakage of CO 2 (14% of cases) may significantly delay the procedure. 7 The addition of towel clamps to the skin, commonly used to prevent CO 2 escape, often leads to subcutaneous emphysema and decreased mobility of the laparoscope. These towel clamps are also traumatic and may increase the rates of infection and scarring. Trocar sleeve destabilization can be overcome by securing the device to the fascia with sutures. Placing fascial sutures does add an additional source of sharp instrumentation to a blunt access technique and may increase the risk of bowel injury to some degree. The need for better trocar stabilization led to the development of the BBTT, which maintains the basic principles of open laparoscopy. The BBTT and trocar were originally used for laparoscopic preperitoneal inguinal hernia repairs and were later incorporated for use in other abdominal laparoscopic procedures. This method offers several advantages over other traditional open access devices. For instance, it does not require the use of sharp instruments or of sutures for trocar stability. The trocar is held in place internally by the balloon and externally by the collar-compressed sponge, which ensures maximum stability in all directions with a full range of motion. An atraumatic airtight seal is created, maintaining the pneumoperitoneum with no loss of CO 2 and avoiding the nuisance of subcutaneous emphysema. The sim-

5 BLUNT-TIP TROCAR FOR CHOLECYSTECTOMY 77 plicity and speed of insertion makes this technique particularly appealing. Once the peritoneum is incised under direct vision, the trocar can be inserted and inflated with minimal difficulty. Insertion of the BBTT is 18% faster than the conventional Hasson method (P, 0.05) and 32% faster than VN entry (P, 0.05). Finally, the BBTT method affords all of the advantages of open laparoscopic access, including peri-incisional inspection for visceral injury, removal of larger stones, and absence of need for bladder catheterization. We find no specific disadvantages intrinsic to the balloon trocar or its use. Although laparoscopic access in the obese patient can be challenging regardless of the method employed, we experienced no difficulty in using the BBTT in these cases. We acknowledge that securing a blunt trocar sleeve during open access with fascial sutures can be difficult as well as time consuming, especially in the obese patient, but the BBTT obviates all such maneuvers. Because approximately 0.03% of patients undergoing laparoscopy have retroumbilical adhesions, there is a potential for bowel injury when entering the peritoneum bluntly with Crile forceps. 8 Unfortunately, this problem is inherent in all laparoscopic access techniques, stressing the fact that no laparoscopic surgery technique is absolutely free of visceral injury. Nevertheless, if the bowel is violated, the injury can be recognized and treated without delay when employing the open BBTT technique. It is necessary to emphasize that meticulous closure of the fascial opening is essential for preventing postoperative herniation, an infrequent but preventable complication of open laparoscopy. The cost of the 10-mm blunt-tip trocar with balloon ($110) is less than either that of the Bluntport 10-mm Hasson trocar ($127) or the Surgineedle 120-mm VN ($40) plus Versaport 10-mm sharp trocar ($130). Although there is not a large discrepancy in the cost of the individual instruments, in large-volume hospitals, the savings from using the blunt-tip trocar may be substantial. Despite our general preference for open access laparoscopy, our series lacks a sufficient number of patients to permit us to draw sound conclusions on safety differences between the described approaches. Considerable controversy remains as to the optimal technique, but most surgeons would agree that because the majority of laparoscopy is performed in the nonemergency setting, safe access should be the utmost priority. The morbidity of open and closed laparoscopy ranges from procedural access difficulties with little danger to the patient but prolonging the operative time to devastating visceral and vascular injuries. The most commonly described serious injuries during laparoscopic access are those associated with blind entrance into the peritoneal cavity by primary introduction of the VN and sharp trocars. The VN, most frequently used to create blind pneumoperitoneum, is efficient but does carry a higher complication rate than the other open access techniques. 9 Preperitoneal insufflation causing subcutaneous emphysema, a minor complication, can make the procedure difficult because of distortion of the normal anatomic planes. This procedural difficulty is not attributed solely to VN and seems to occur during both open and closed approaches. Subcutaneous emphysema was seen in three patients in our series, two patients in the HA group, and one in the VN group, but was not observed in any patients in the BBTT group. In fact, we have seen subcutaneous emphysema in only two patients outside of this study using this technique, and those leaks were suspected to originate from the 5-mm subxiphoid port. The complication occurs when CO 2 is insufflated or dissects into the preperitoneal space and abdominal wall, most commonly because of inadequate fascial trocar seal or improper VN positioning. In severe cases, subcutaneous emphysema can cause CO 2 narcosis, necessitating prolonged ventilation. Gas embolism secondary to subcutaneous emphysema, although unlikely (0.0003% incidence), has been reported. 10 More serious injuries to blood vessels, the bowel, and the retroperitoneum have been described and can be catastrophic. The actual incidence of vascular injury is difficult to establish, but it has been estimated at 0.2 to 0.6/1000 cases for VN and sharp trocar insertion, respectively. 11 Most literature indicates that the injuries are secondary to the trocar insertion and not the Veress needle. 1,11 Conversely, there have been no reported incidents of vascular injuries associated with open laparoscopy. 9,12 With regard to iatrogenic visceral lesions from closed laparoscopy, the estimated incidence is 0.083%. 1 Even though the open technique may decrease the incidence of visceral injury, it does not completely prevent it. In fact, the estimated incidence of visceral injuries in open laparoscopy is 0.048%. 1 Nevertheless, when injury occurs, the open technique ensures prompt recognition and repair, whereas visceral injuries during the closed method are more likely to go unnoticed. 13 Despite their rarity, these injuries carry a significant morbidity and mortality. Deziel and colleagues 13 reported the mortality related to vascular injury as 8.8% and 4.6% for cases of bowel injury. When large retroperitoneal vessels are involved (aorta, vena cava, or iliac artery), the mortality rate can be as high as 15%. 3,14 The suspected etiologies of closed entry injuries are numerous: the skill of the surgeon, inadequate pneumoperitoneum, perpendicular insertion of a trocar, and failure to recognize anatomic landmarks. 15 It is our speculation that the incidence of injury in both open and closed access laparoscopy is in fact higher, but most injuries go unreported during laparoscopic surgery. Regardless of the etiology,

6 78 BERNIK ET AL. injury to the abdominal contents is more likely to occur from blind insertion of a sharp instrument rather than by direct vision and placement of a blunt trocar. CONCLUSION We believe the proposed method and instrumentation described herein are significant improvements over previous techniques of open laparoscopy as well as the Veress needle approach. The balloon blunt-tip trocar provides safe, fast, simple access with increased maneuverability and stability. We routinely use this trocar for all cases of LC and believe it has applications for use in most abdominopelvic laparoscopic operations. REFERENCES 1. Bonjer HJ, Hazebroek EJ, Kazemier G, Giuffrida MC, Meijer WS, Lange JF. Open versus closed establishment of pneumoperitoneum in laparoscopic surgery. Br J Surg 1997;84: Hasson HM. A modified instrument and method for laparoscopy. Am J Obstet Gynecol 1971;110: Oshinsky GS, Smith AD. Laparoscopic needles and trocars: An overview of design and complications. J Laparosc Surg 1992;2: James WPT. What are the health risks? The medical consequences of obesity and its health risks. Exp Clin Endocrinol Diabetes 1998;106(suppl 2): Ohl DA, Faerber GJ, Hurd WW. Urologic laparoscopy with a new blunt-tipped trocar: Safe, rapid access without the use of fascial sutures. Urology 1994;43: Byron JW, Markenson G, Miyazawa K. A randomized comparison of Veress needle and direct trocar insertion for laparoscopy. Surg Gynecol Obstet 1993;177: Hurd WW, Randolph JF, Holmberg RA, Pearl ML, Hubbell GP. Open laparoscopy without special instruments or sutures: Comparison with closed technique. J Reprod Med 1994;39: Kaali SG, Barad DH. Incidence of bowel injury due to dense adhesions at the sight of direct trocar insertion. J Reprod Med 1992;37: Cogliandolo A, Manganaro T, Saitta FP, Micali B. Blind versus open approach to laparoscopic cholecystectomy. Surg Laparosc Endosc 1998;5: Mintz M. Risks and prophylaxis in laparoscopy: A survey of 100,000 cases. J Reprod Med 1977;18: Lehmann-Willenbrock E, Riedel HH, Mecke H, Semm K. Pelviscopy/laparoscopy and its complications in Germany J Reprod Med 1992;37: Sigman HH, Fried GM, Garzon J, Hinchey EJ, Wexler MJ, Meakins JL, Barkun JS. Risks of blind versus open approach to celiotomy for laparoscopic surgery. Surg Laparosc Endosc 1993;3: Deziel DJ, Millikan KW, Economou SG, Doolas A, Ko ST, Airan MC. Complications of laparoscopic cholecystectomy: A national survey of 4,292 hospitals and an analysis of 77,604 cases. AJR Am J Roentgenol 1993;165: Bongard F, Dubecz S, Klein S. Complications of therapeutic laparoscopy. Curr Prob Surg 1994;31: Penfield AJ. Trocar and needle injuries: In: Phillips JM (ed): Laparoscopy. Baltimore: Williams & Wilkins, 1997, pp Address reprint requests to: Thomas R. Bernik, M.D. Department of Vascular Surgery North Shore University Hospital 300 Community Drive Manhasset, NY bernik@optonline.net