J Gastrointest Surg (2009) 13:1733–1740 DOI 10.1007/s11605-009-0902-y
REVIEW ARTICLE
A Comprehensive Review of Single-Incision Laparoscopic Surgery (SILS) and Natural Orifice Transluminal Endoscopic Surgery (NOTES) Techniques for Cholecystectomy Ronald Scott Chamberlain & Sujit Vijay Sakpal
Received: 3 February 2009 / Accepted: 15 April 2009 / Published online: 2 May 2009 # 2009 The Society for Surgery of the Alimentary Tract
Abstract Introduction Surgery of the gallbladder has evolved tremendously over the last century. Laparoscopic cholecystectomy is the gold standard for gallbladder removal and the most common laparoscopic procedure worldwide. In recent times, innovative techniques of natural orifice transluminal endoscopic surgery (NOTES) and single-incision laparoscopic surgery (SILS) have been applied in gallbladder removal as a step towards even more less-invasive procedures. Discussion While NOTES and SILS represent the advent of essentially scarless surgery, limited applications of these technologies in human subjects exists. In this article, we present a comprehensive review of the potential benefits, limitations and risks of these novel techniques. Conclusion While much remains unknown and unanswered surrounding these procedures, it is clear that extensive research and development with regards to the ethics and the technical aspects of these procedures as well as randomized studies to compare them with traditional laparoscopy are essential. Keywords Cholecystectomy . Natural orifice transluminal endoscopic surgery . NOTES . Single-incision laparoscopic surgery . SILS
Introduction Laparoscopy has blossomed over the last 20 years and is one of the most significant surgical advances of the twentieth century. However, the true birth of laparoscopy can be dated to over 100 years ago when George Kelling from Dresden, Germany introduced a cystoscope into the peritoneal cavity of a living dog and insufflated air to enhance the view.1 Surgery of the gallbladder has similarly evolved over this R. S. Chamberlain (*) : S. V. Sakpal Department of Surgery, Saint Barnabas Medical Center, 94 Old Short Hills Road, Livingston, NJ 07039, USA e-mail:
[email protected] R. S. Chamberlain Department of Surgery, University of Medicine & Dentistry of New Jersey, Newark, NJ, USA
same century. As cited by Bittner,2 Langenbuch performed the first successful cholecystectomy on a 43-year-old man with symptomatic cholelithiasis in 1882. More than a century later (in 1985) German surgeon Eric Muhe applied the technique of laparoscopy to remove a gallbladder using a modified laparoscope, called the galloscope.3 It was soon thereafter (1987) that the advent of the computer chip television camera allowed Phillipe Mouret to perform the first video-laparoscopic cholecystectomy.4 Today, laparoscopic cholecystectomy is the gold standard for gallbladder removal and the most common laparoscopic surgical procedure in the world.5 Numerous reports have provided overwhelming evidence that laparoscopy provides better cosmetic results, less postoperative pain, and shorter recovery time when compared with open cholecystectomy.2 However, the quest to develop even more minimally invasive surgical techniques in order to enhance the advantages of laparoscopy remains robust. This quest has led surgeons to seek to minimize the number and the size of incisions, or in the case of natural orifice transluminal endoscopic surgery (NOTES), to eliminate skin incision(s) altogether. The hope of these more minimally invasive procedures is that they will also lead
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to minimal or no post-procedural pain while improving cost-effectiveness and patient safety. While totally incisionless surgery remains an impossible idea at present, NOTES, initially performed in animal models,6 is now a clinically relevant idea with anecdotal procedures having been performed on human subjects worldwide. Reddy and Rao7 are credited with performing the first transgastric appendectomy in a human without an external incision, and Marescaux et al.8 performed the first cholecystectomy via a natural orifice. As a bridge between traditional laparoscopy and NOTES, recent focus has been on the development of single-incision laparoscopic surgery (SILS) to further minimize the invasiveness of laparoscopy by reducing the number of incisions, and hopefully the pain and complication(s) associated with them. SILS was described as early as 1992 by Pelosi and Pelosi9 who performed a single-puncture laparoscopic appendectomy and in 1997 by Navarra et al.10 who performed a laparoscopic cholecystectomy via two transumbilical trocars and three transabdominal gallbladder stay sutures. These innovations, either exclusively or in a hybridized fashion, have now been applied to a wide variety of surgical procedures.
A Review of Novel and Innovative Minimally Invasive Cholecystectomies A large number of individualized techniques for NOTES or SILS for a variety of different operations have been described. The described procedures include appendectomies,9,11–13 gastrostomies14,15 and gastrectomies,16,17 adrenalectomies,18 colorectal19–22 and bariatric16 procedures, and urologic procedures23,24 including donor nephrectomies.25–27 To date, however, cholecystectomy appears to be the most common surgical procedure to which significant efforts have been applied toward the development of technique and equipment for both NOTES and SILS. We will spend the remainder of the article reviewing these novel and innovative techniques that have been described for more minimally invasive cholecystectomy, and provide a discussion of the positives and negatives associated with these innovations. Natural Orifice Transluminal Endoscopic (NOTES) Cholecystectomy Techniques Bessler et al.28 have described a transvaginal laparoscopically assisted endoscopic cholecystectomy using a single 5-mm trocar and two 3-mm trocars through the anterior abdominal wall. The sole purpose of the 5-mm trocar was to introduce a clip applier while the 3-mm trocars were used to retract the gallbladder, induce and maintain pneumo-
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peritoneum, and assist in the creation and dilation of an incision in the posterior fornix of the vagina for gallbladder removal. A double-channel endoscope was introduced transvaginally into the peritoneal cavity to permit dissection, and removal of the gallbladder was completed entirely with a hook knife and a grasper that was inserted through the endoscopic channels. Following removal of the gallbladder, the colpotomy was closed with absorbable sutures. The entire procedure took 3.5 h. A similar technique used by Marescaux et al.8 required only a single 2-mm transumbilical needle port to create pneumoperitoneum and provide laparoscopic guidance for the colpotomy. Endoscopic scissors, grasper, and a unipolar round-tipped electrode were used to dissect and remove the gallbladder. The entire procedure took 3 h to complete. Zornig et al.29,30 have described a slightly different technique of transvaginal cholecystectomy in which the umbilical scope is replaced with a dissector, and the 10-mm 30° scope is introduced transvaginally. A total of 20 cholecystectomies were performed in this manner with an average operating time of 62 min. Reduction in operative time as compared with the prior techniques is likely attributable to insertion of instruments across two perpendicular planes which achieves better triangulation, and the fact that the majority of operated patients (14/20) had noneto-minimal signs of gallbladder inflammation. Note that one out of the three patients with chronic cholecystitis required an additional incision for insertion of a drain secondary to operative trauma to the liver tissue. Finally, Forgione et al.31 have described a third transvaginal technique employing a single incision in the left upper quadrant which is used to create pneumoperitoneum, provide laparoscopic assistance to make the posterior colpotomy, while also permitting retraction of the gallbladder and insertion of a 5-mm laparoscopic clip applier. These authors also performed routine proctoscopy at the end of the procedure to exclude iatrogenic rectal injury. The mean operative time for the three cases reported was more than 136 min. Single-incision Laparoscopic (SILS) Cholecystectomy Techniques Navarra et al.10 performed the first SILS cholecystectomy in 1997 using two 10-mm trocars and three transabdominal stay sutures to aid in gallbladder retraction. Piskun and Rajpal32 described the use of two 5-mm trocars and two stay sutures in 1999. In both these methods, the two trocars were inserted through the umbilicus, with a bridge of fascia between them, and were used for a camera and a working instrument, respectively. The two umbilical fascial incisions were united by cutting the bridge between them to allow retrieval of the gallbladder following its removal. In place
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of sutures, Cuesta et al.33 have described a technique in which a percutaneous Kirschner wire is introduced subcostally and modified into a hook intra-peritoneally. This wire hook was used to provide exposure of Calot’s triangle. The authors used this technique to successfully treat ten female patients with cholelithiasis, with an average operative time of 70 min. Tacchino et al.5 have reported a series of 12 singleincision laparoscopic cholecystectomies. In their technique, a single 12-mm umbilical incision was created to induce pneumoperitoneum with a Veress needle and expose the fascia for introduction of a 30° scope through a 5-mm trocar. Roticulator endoshear and endograsper inserted within two separate trocars, introduced to the left and right of the first, were used to perform dissection in a normal retrograde pattern. Two straight-needle sutures passed through the gallbladder fundus, near the infundibulum, and the right subcostal abdominal wall suspended the gallbladder and exposed the Calot’s triangle. A thin percutaneous needle was used to empty the gallbladder. Following complete dissection and excision of the gallbladder, the suspension stitches were removed and the gallbladder retrieved through the umbilical incision in a standard fashion. Of the 12 patients that underwent this operation, two complications were observed (16.6%). In one case, the patient sustained trauma to the abdominal wall due to the multiple trocars inserted at the single umbilical incision and developed a subcutaneous hematoma that required evacuation. Another patient experienced persistent postoperative abdominal pain secondary to an intraabdominal collection that most likely occurred due to bleeding from the liver which spontaneously resolved but extended the patient’s hospital stay (length of stay, 7 days). Gumbs et al.34 essentially imitated the procedures performed by Cuesta et al.33 and Tacchino et al.,5 except that they were able to operate with a deflecting laparoscope, an articulating grasper, a straight dissector, and without suspension sutures. Rao et al.35 described an innovative piece of instrumentation which they utilized to perform 20 SILS cholecystectomies. The equipment was termed an R-Port® (Advanced Surgical Concepts, Wicklow, Ireland), which consisted of a double-layered plastic cylinder that serves as a single port, and is introduced through a 15–25-mm incision in the umbilicus. The device has three valvular openings on the port which permit insertion of either three 5-mm or one 10-mm and one 5-mm instruments. The instrument shafts used were angulated to avoid clashing and provide triangulation during dissection. Using these tools, the authors successfully performed cholecystectomy in 85% of the patients upon whom it was attempted with an average operative time of 40 min. In seven of the 17 cases completed, a stay suture in the right subcostal area was
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required to expose the Calot’s triangle. Two patients with choledocholithiasis required an additional R-Port® to insert the choledochoscope for CBD exploration. Importantly, the authors noted the complexity of the procedure, despite careful selection of patients which excluded those with severe acute cholecystitis or history of pancreatitis, but nevertheless achieved a successful outcome in the vast majority of patients. A similar technique, using a TriPort® system (Advanced Surgical Concepts, Wicklow, Ireland), has also been reported by Romanelli et al.36 in the completion of their first case of SILS cholecystectomy. Merchant et al.16 have reported the completion of 21 SILS cholecystectomies using a similar multi-channel port termed the Gelport® system (Applied Medical, Rancho Santa Margarita, CA, USA). The operative times ranged from 45–90 min; however, the average time per procedure was not reported. Their technique requires a wound retractor (part of the Gelport® system) to be inserted through a 1 cm umbilical incision to stretch the fascial diameter to 1.5 cm. The Gelport® is then latched on to the wound retractor ring allowing up to four instrument trocars including the videoscope to be inserted at any given time with “flexible fulcrums” that ease mutliplanar motions. All patients in the series by Merchant et al.16 had symptomatic cholelithiasis, and one of the two who had acute cholecystitis required placement of an accessory port in the right upper quadrant to achieve safe dissection. Zhu et al.37 have performed a total of 40 different cases of transumbilical endoscopic surgery (TUES) using special instruments including a trichannel umbilical trocar (15 mm in diameter) which allows for insertion of a flexible endoscope or a laparoscope through the 5-mm channel and semirigid working instruments through each of the other two 2.8-mm channels. These authors have performed two cases of liver cyst fenestration and nine appendectomies using these instruments brought through a single abdominal incision. In addition, they have performed six cholecystectomies using a trichannel trocar and another 20 using a double-trocar technique through the umbilicus. In all cholecystectomies, a 2-mm grasper, inserted through an extra incision in the right upper abdomen, was used to retract the gallbladder. They were able to successfully remove the gallbladder using this technique in all but one case which required conversion to standard laparoscopic procedure for uncontrolled hemorrhage. Palanivelu et al.38 performed a study to assess the feasibility of a minimally invasive hybrid cholecystectomy technique. The procedure used a 2-mm Veress needle placed transumbilically to create pneumoperitoneum with the subsequent placement of a 15-mm double-channel endoscope through which working instruments were introduced. Another 3-mm trocar was inserted in the left hypochondrium to retract the gallbladder. Ten wellselected cholelithiasis patients (four males, six females;
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average age 29.5 years), excluding those they thought may have complicated disease, underwent this hybrid procedure and 50% were completed successfully. Four of the ten cases were converted to conventional laparoscopic cholecystectomy due to uncontrollable hemorrhage from the cystic artery (two) and difficulty in dissection (two). One of the six patients who underwent the hybrid procedure was readmitted on the fourth postoperative day for a biliary leak (90 ml biloma) due to clip slippage from the cystic duct stump. This complication was treated with an endoscopic retrograde cholangiopancreatography (ERCP) and bile duct stenting. Table 1 provides an overview of comparative features of the above-described techniques of NOTES and SILS cholecystectomy, respectively.
Discussion NOTES and SILS mark the beginning of a new era in the field of surgery. Endoscopic surgery via natural orifices is essentially surgery without a visible scar, and marks a prominent evolutionary leap in medicine. Single-incision laparoscopy purports to offer better cosmesis and avoidance of extra incisions, with an added benefit of the option to convert to multiport laparoscopy if necessary. It has further been suggested that both NOTES and SILS may be associated with reduced post-procedural pain when compared to traditional laparoscopy. While some of the aforementioned reports suggest a promising future for these innovative techniques, the promise currently remains unfulfilled as significant ethical, procedural, and technological questions remain (summarized in Table 2). Natural orifice endoscopic procedures are performed with flexible endoscopy and at present most surgeons have little, or more commonly no experience with their use in the abdominal cavity (or elsewhere). In transgastric or transcolonic NOTES, the lack of sterilization and secure closure of the gastric or colonic wall remains the greatest challenge since the development of gastrointestinal leaks would represent a catastrophic complication which rarely follows routine laparoscopic cholecystectomies and appendectomies.28,30,38 In our opinion, until improved technology and training is available and a robust discussion of the ethics of NOTES is held, the purported benefits of better cosmesis in no way outweigh the risks posed by potential intra-abdominal injuries. Though no meaningful data regarding complication of NOTES procedures are available in any form, it would appear that the paucity of infections or hernia following transvaginal pelvic surgery, even when the colpotomy is not routinely closed, makes the transvaginal route a preferred option over transgastric or transcolonic methods.39 However, it is important to note that no information on the impact of the transvaginal approach on
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subsequent fertility and the potential for discomfort during sexual intercourse exists. In our practice, an attending surgeon, a surgical resident and an assistant (usually a medical student) in addition to the nursing staff makes up the laparoscopic cholecystectomy operative team. We performed the last 100 laparoscopic cholecystectomies in an average time of 51 min. Most of the reported NOTES were carried out by a team of surgeons, gynecologists, and gastroenterologists in various combinations. This not only signifies the complexity of this technique, but also suggests that the reported operative times alone do not precisely reflect the cumulative manhours invested by specialists in the performance of these procedures. Varadarajulu et al.40 surveyed 100 patients who were undergoing endoscopic ultrasound (EUS) or an ERCP for evaluation of abdominal pain, pancreatitis, or suspected choledocholithiasis. All patients were given information on the technique, complication rates, and benefits of laparoscopic cholecystectomy. In addition, the concept of NOTES, as an evolving less-minimally invasive technique, for gallbladder removal was described simultaneously. Patients were then queried regarding the cholecystectomy technique (laparoscopic versus NOTES) they preferred, reason(s) for their choice and the amount of risk that they were willing to assume if they selected NOTES. Seventyeight percent of these patients expressed preference toward NOTES over laparoscopic cholecystectomy if the complication rates of the procedures in question were comparable. The most common reason given for preferring NOTES was to avoid incisional pain and scarring. This raises two important questions: what is the complication rate associated with NOTES and SILS cholecystectomy, and is the post-procedural pain following either NOTES or SILS cholecystectomy any different from that reported after traditional laparoscopy? We know that the incidence rate of major complications (common bile duct and major vessel injury) following three or four-trocar laparoscopic cholecystectomy is well documented at
