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    Outpatient single-incision laparoscopic cholecystectomy in 22 patients with gallbladder disease

    2010-07-07 00:59:38WuJiKaiDingRongYangXingDongLiuNingLiandJieShouLi

    Wu Ji, Kai Ding, Rong Yang, Xing-Dong Liu, Ning Li and Jie-Shou Li

    Nanjing, China

    Outpatient single-incision laparoscopic cholecystectomy in 22 patients with gallbladder disease

    Wu Ji, Kai Ding, Rong Yang, Xing-Dong Liu, Ning Li and Jie-Shou Li

    Nanjing, China

    BACKGROUND:Transumbilical single-incision laparoscopic cholecystectomy (SILC) is a new procedure. It has been described by some authors as scarless surgery. To our knowledge, however, there has been no study on outpatient SILC. The present study was designed to determine the safety, feasibility and benefits of transumbilical outpatient SILC.

    METHODS:Twenty-two patients underwent transumbilical outpatient SILC at our department from December 2008 to October 2009. In all patients, the preoperative work-up and operation were completed in the outpatient clinic. To perform the operation, a 2- to 2.5-cm semi-circular incision was made around the umbilicus and three 5-mm trocars were inserted separately by direct puncture. A 5-mm flexible laparoscope, an UltraCision harmonic scalpel and curved instruments were used to perform the laparoscopic cholecystectomy (LC) procedure.

    RESULTS:All patients except one were operated on successfully. The conversion rate to standard LC was 5%. In the 21 successfully completed patients, the median duration of operation was 56.5 minutes and estimated operative blood loss was 16.2 ml. The time to resume liquid food was 10.8 hours and semi-liquid food was 16.2 hours after the operation. Nine patients went home on the same day, and 12 on the second day after the operation. The mean postoperative hospital observation time was 18.5 hours. Urinary retention was observed in 1 patient. The follow-up was conducted for all patients at 2 weeks after surgery. All patients were satisfied with the good cosmetic effect of the surgery. The total satisfaction rate was 95%.

    CONCLUSIONS:Outpatient SILC is a safe and feasible technique for operating with fewer scars and reducing perioperative discomfort at the same time. A direct puncture method to insert trocars is technically feasible. Using a flexible laparoscope and curved instruments make the procedure easier and more time-saving.

    (Hepatobiliary Pancreat Dis Int 2010; 9: 629-633)

    single-incision surgery; outpatient surgery; laparoscopic cholecystectomy; natural orifice transluminal endoscopic surgery

    Introduction

    In recent years, several studies have shown that outpatient laparoscopic cholecystectomy (LC) is feasible and safe.[1,2]It provides a fast bed turnover rate and reduces total cost compared to standard LC; therefore, it has been widely accepted. Meanwhile, interest has focused on scarless endoscopic abdominal surgery with the development of techniques in minimally invasive surgery.[3,4]The concept known as natural orifice transluminal endoscopic surgery (NOTES) appeared in 2004, and transumbilical single-incision laparoscopic surgery (SILS) is regarded as the most feasible NOTES procedure at present.[5,6]To our knowledge, however, there has been no study on outpatient SILS. To determine the safety, feasibility and benefits of outpatient SILS, we performed outpatient transumbilical single-incision laparoscopic cholecystectomy (SILC) for 22 patients. In this paper we report our initial clinical experience with this new technique.

    Methods

    Eligibility of patients

    From December 2008 to October 2009, outpatient transumbilical SILC was performed for 22 patientsat our department, of whom 17 were female and 5 male, with a mean age of 35 years (range 18-59 years). Among the patients 15 suffered from chronic calculus cholecystitis and 7 from gallbladder polyps. Eighteen patients were of gradeiand 3 were of grade II according to the physical status scoring system of the American Society of Anesthesiologists.

    Preoperative preparation

    The preoperative work-up items for transumbilical outpatient SILC were the same as for routine LC, and these tests were completed in the outpatient clinic. On the morning of the operation, the patient and his/her family members who were to accompany him/ her during the post-operative period arrived at the outpatient surgery center in our hospital 1 hour before the planned operation. The patients had fasted for more than 6 hours.

    Anesthesia and intraoperative management

    The LC procedure had been standardized for patients under general anesthesia. Anesthesia was induced with propofol, remifentanil and atracurium. At that time, the patients were intubated and continuously anesthetized by inhalational anesthesia. In the induction period, a single dose of cefotiam, a broad-spectrum antibiotic, was given intravenously for infection prophylaxis. Intraoperatively, electrocardiography, arterial line monitoring, and blood gas analysis were continued. Before the end of the operation, dexamethasone and granisetron were used to prevent postoperative nausea and vomiting, as well as flurbiprofen for relief of postoperative pain.

    Surgical techniques

    To perform the operation, a 2-2.5-cm semi-circular incision was made around the umbilicus, and Calot's triangle was then carefully dissected until the fascia were identified. A CO2pneumoperitoneum was established by a Veress needle with a pressure of 12-15 mmHg. Two 5-mm semi-rigid trocars and one 5-mm ordinary trocar were inserted separately by direct puncture, without any commercially available single port access device (Fig. 1). A 5-mm flexible videoscope (EndoEye; Olympus Medical, Tokyo, Japan) and operative instruments, including an UltraCision harmonic scalpel (Olympus Medical, Japan) and curved grasper, dissector and hook (Kangji Medical Instrument Co., Hangzhou, China), were inserted through these lumens (Fig. 2). Calot's triangle was dissected with an electronic hook and the UltraCision scalpel. The cystic vessel was cut by the UltraCision scalpel and the cystic duct was closed by a Hem-o-lok (Releflex Medical, USA). The gallbladder was pulled upward to expose the gallbladder bed, which was then separated from the liver by an electronic hook. Bleeding in the gallbladder bed was coagulated and the operative field was irrigated and suctioned. The gallbladder specimen was put into a sample bag and extracted through the incision. The incision was closed by suturing the fascia layer and gluing the skin.

    Fig. 1. Three 5-mm trocars were inserted separately by direct puncture.

    Fig. 2. Curved instruments and a flexible laparoscope were used.

    Postoperative management

    After the operation, the patients were sent to the postoperative resuscitation room for extubation and immediate postoperative care, and then to the observation room in the outpatient clinic where vital signs were monitored and intravenous fluid was administered. Twelve hours later, the surgeon and the anesthetist evaluated jointly if the patient could be discharged. For the patients to be discharged, they had to meet the following: 1) vital signs stable for more than 4 hours; 2) being awakened, alerted and orientated to people, place and time; 3) function independently for dressing and walking; and 4) no complaints of nausea, vomiting, severe pain or bleeding around the incision. The criteria for hospital stay for further observation were: 1) fluctuating vital signs during the postoperative period; 2) symptoms of nausea, vomiting and pain that were not completely resolved; and 3) patients and family members expressing a strong desire to stay in hospital. Patients discharged on the same day after the operationwere requested to contact the hospital shortly after they settled down at home and in the next 24 hours. All the patients were reached at least once by the nursing staff to evaluate their conditions. Moreover, the patients could also consult the surgeons and their associates via the internet at any time with regard to any issue related to surgery and postoperative care. Patients who stayed in the hospital for further observation were continuously observed and cared for in the observation room, and reassessed by the surgeons for possible discharge on the second postoperative day.

    Observation indices

    The success rate of LC, duration of operation, estimated operative blood loss, time to resume liquid food and semi-liquid food after surgery, surgical complications, length of postoperative stay, and total cost were retrospectively collected from our patient information database. Patient satisfaction with surgery and postoperative management was graded by the patients in the 2 weeks after surgery when the nurses in the clinic conducted telephone interviews, with a questionnaire that listed 10 items with a score of 1-10. Statistical analysis was performed with SPSS version 13.0 software, which was used to establish the database for the analysis.

    Results

    One transumbilical outpatient SILC was converted to routine LC owing to uncontrollable intraoperative bleeding. The conversion rate was 5%. In the 21 patients undergoing successful operation the median duration of the operation was 56.5 minutes (range 38-136 minutes) and estimated operative blood loss was 16.2 ml (range 5-35 ml). No drainage was placed in the abdominal cavity in these patients. The time to resume liquid food was 10.8 hours (range 6-15 hours) and semi-liquid food was 16.2 hours (range 13-22 hours) after the operation. Nine patients went home on the same day, and 12 on the second day after the operation. There was no hospital re-admission after surgery. The mean time for postoperative hospital observation was 18.5 hours (range 8-25 hours). Urinary retention occurred in 1 patient after surgery, which was cured by conservative treatment. Follow-up was conducted for all patients at 2 weeks after surgery. All patients were satisfied with the good cosmetic effect of the surgery (Fig. 3). Sixteen patients expressed extreme satisfaction, 5 were satisfied, and only 1 was dissatisfied (this patient complained of pain and vomiting after the first day at home). The total satisfaction rate was 95%.

    Fig. 3. The incision was nearly invisible. A: One day after surgery; B: 1 month after surgery.

    Discussion

    Laparoscopic surgery is a well-established alternative to open surgery across disciplines. The benefits of laparoscopy for postoperative pain, cosmesis, hospital stay, and convalescence are widely recognized. With advances in the field of laparoscopy and other minimally invasive surgeries in recent decades, attempts to achieve better cosmetic effects and minimize accessrelated injuries and complications have resulted in the development of NOTES, which has been introduced in recent years. Operations using the NOTES technique avoid external incisions by using a natural orifice, such as the mouth, anus, or vagina, followed by making an internal incision, such as in the vagina, colon or stomach, to insert the laparoscopic or endoscopic instruments. Thus, a viscerotomy is performed. The first experimental NOTES procedure was reported by Kalloo et al[7]in 2004, who concluded that it was feasible with the possible advantages of improved patient recovery, reduced need for anesthesia, and better cosmetic results. Since then, many publications on NOTES have focused on tubal ligation, gastrojejunostomy, splenectomy, and cholecystectomy in animals. However, only a few clinical reports have appeared to date. The major barriers that limit clinical application of NOTES include access and closure of internal incision, abdominal infection, suturing technology, and orientation.[8]

    Because of the limitations of NOTES, great efforts have been made to find other feasible options that can replace NOTES in the current situation. Transumbilical SILS is the most available and widely applicable technique.[9-11]The fundamental idea of SILS is to have all of the laparoscopic working ports entering the abdominal wall through one incision in the embryonic natural orifice, the umbilicus. The obvious advantages of this approach are that it is nearly scarless and is associated with less pain, faster postoperative recovery, and reduced cost. Single-incision access also reduces the risk of complications such as port injury, hernia and infection. The single external incision made with the SILS technique is nearly invisible if placed within thepatient's navel, and therefore, subjectively not seen as a disadvantage compared with NOTES. In contrast to NOTES, SILS is comparatively easy for a laparoscopic surgeon using conventional or modified laparoscopic instruments. Besides, it does not require the opening of a hollow organ, such as the stomach or vagina. Thus, complications related to visceral closure, such as gastrotomy or leakage, are avoided.[12-14]Romanelli et al[15]have even conjectured that SILS could be the next generation of minimally invasive surgery. The concept of performing laparoscopic surgery via a single-incision regardless of the technique is attractive among patients, surgeons and investors. It is likely that the public will demand this even less-invasive surgical approach much in the same way that it forced the expansion of laparoscopic surgery two decades ago. Transumbilical SILC was first reported by Podolsky et al in 2007.[16]Its feasibility and safety have been confirmed by many studies.[15,17]However, there has not yet been any report on outpatient SILC.

    The practice of outpatient laparoscopic surgery, especially outpatient LC, was conceptualized in the early 1990s. It has been shown that outpatient LC shortens hospital stay and substantially lowers medical costs. Studies have reported that outpatient LC procedures account for 60%-90% of routine LC procedures in several medical centers in the United States and other countries, and most patients are safely discharged after 6-12 hours postoperative observation.[18]We initiated outpatient LC first in China in April 2007. We have performed more than 300 outpatient LC procedures up to April 2009 in our institution. During this period, we have optimized the clinical pathway for implementation of outpatient LC based on the actual conditions in China.[19]In December 2008, we began to perform transumbilical outpatient SILC and had performed for 22 patients by October 2009. We found that transumbilical outpatient SILC is feasible and safe. The operative time was longer, but the complication rate was no higher than that of standard LC. The patients were satisfied with this surgery, especially its cosmetic effect. A number of methods have been described for port access to perform SILS, and commercially available single port access devices have mostly been adopted.[20,21]Transumbilical direct puncture for separate insertion of trocars was used in the present study. We found that it is technically feasible with just a little CO2leak if the puncture is at the proper anatomic layer. Outpatient SILC is a hybrid technique of outpatient LC and SILC, thus it has the benefits of both techniques. It allows the patients to follow their own schedules for preoperative examinations and surgery. It can shorten postoperative stay as well as waiting time for surgery, indicating that outpatient SILC is financially beneficial to patients and hospitals. It also quickens the return of patients to work and normal life, leading to better social results. However, outpatient SILC is a new technique with great challenges. It is more difficult than standard laparoscopic surgery, when completed in the outpatient clinic.[22,23]With all new technologies, patient selection is paramount during the initial period of gaining experience. Besides, because of the limited space that results from the use of only a single port, the hands of the surgeon and the assistant are at risk of interfering with each other. Therefore, new instruments suitable for this procedure are needed to facilitate the operation. In the present study, the Calot triangle was easily and quickly visualized and dissected using curved instruments and a flexible laparoscope, and the procedure was more comfortable for surgeons than previously reported SILC with conventional laparoscopic instruments. However, large, randomized, prospective studies are needed to confirm the safety, feasibility, cost-effectiveness and patient satisfaction of outpatient SILC.

    Funding:This study was supported by a grant from the Fund of Medical Science Project of the PLA (No. 08Z007).

    Ethical approval:Not needed.

    Contributors:LJS proposed the study. JW and LJS wrote the first draft. JW analyzed the data. All authors contributed to the design and interpretation of the study and to further drafts. LJS is the guarantor.

    Competing interest:No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

    1 Gurusamy K, Junnarkar S, Farouk M, Davidson BR. Metaanalysis of randomized controlled trials on the safety and effectiveness of day-case laparoscopic cholecystectomy. Br J Surg 2008;95:161-168.

    2 Tenconi SM, Boni L, Colombo EM, Dionigi G, Rovera F, Cassinotti E. Laparoscopic cholecystectomy as day-surgery procedure: current indications and patients' selection. Int J Surg 2008;6:S86-88.

    3 Mintz Y, Horgan S, Cullen J, Stuart D, Falor E, Talamini MA. NOTES: a review of the technical problems encountered and their solutions. J Laparoendosc Adv Surg Tech A 2008;18:583-587.

    4 Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg 2009;13:1733-1740.

    5 Vidal O, Valentini M, Espert JJ, Ginesta C, Jimeno J, Martinez A, et al. Laparoendoscopic single-site cholecystectomy: a safe and reproducible alternative. J Laparoendosc Adv Surg Tech A 2009;19:599-602.

    6 Salinas G, Saavedra L, Agurto H, Quispe R, Ramírez E, Grande J, et al. Early experience in human hybrid transgastric and transvaginal endoscopic cholecystectomy. Surg Endosc 2010;24:1092-1098.

    7 Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc 2004;60:114-117.

    8 Schwaitzberg SD, Kochman ML, Hawes RH, Rattner DW. Natural orifice translumenal endoscopic surgery (NOTES): is it time for introduction to clinical practice? Surgery 2009; 146:841-842.

    9 Abe N, Takeuchi H, Ueki H, Yanagida O, Masaki T, Mori T, et al. Single-port endoscopic cholecystectomy: a bridge between laparoscopic and translumenal endoscopic surgery. J Hepatobiliary Pancreat Surg 2009;16:633-638.

    10 Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg 2009;13:188-192.

    11 Edwards C, Bradshaw A, Ahearne P, Dematos P, Humble T, Johnson R, et al. Single-incision laparoscopic cholecystectomy is feasible: initial experience with 80 cases. Surg Endosc 2010; 24:2241-2247.

    12 Hirano Y, Watanabe T, Uchida T, Yoshida S, Tawaraya K, Kato H, et al. Single-incision laparoscopic cholecystectomy: single institution experience and literature review. World J Gastroenterol 2010;16:270-274.

    13 Carr A, Bhavaraju A, Goza J, Wilson R. Initial experience with single-incision laparoscopic cholecystectomy. Am Surg 2010;76:703-707.

    14 Kirschniak A, Bollmann S, Pointner R, Granderath FA. Transumbilical single-incision laparoscopic cholecystectomy: preliminary experiences. Surg Laparosc Endosc Percutan Tech 2009;19:436-438.

    15 Romanelli JR, Roshek TB 3rd, Lynn DC, Earle DB. Singleport laparoscopic cholecystectomy: initial experience. Surg Endosc 2010;24:1374-1379.

    16 Navarra G, Pozza E, Occhionorelli S, Carcoforo P, Donini I. One-wound laparoscopic cholecystectomy. Br J Surg 1997;84: 695.

    17 Paquette IM, Smink D, Finlayson SR. Outpatient cholecystectomy at hospitals versus freestanding ambulatory surgical centers. J Am Coll Surg 2008;206:301-305.

    18 Ji W, Ding K, Li LT, Wang D, Li N, Li JS. Outpatient versus inpatient laparoscopic cholecystectomy: a single center clinical analysis. Hepatobiliary Pancreat Dis Int 2010;9:60-64.

    19 Philipp SR, Miedema BW, Thaler K. Single-incision laparoscopic cholecystectomy using conventional instruments: early experience in comparison with the gold standard. J Am Coll Surg 2009;209:632-637.

    20 Binenbaum SJ, Teixeira JA, Forrester GJ, Harvey EJ, Afthinos J, Kim GJ, et al. Single-incision laparoscopic cholecystectomy using a flexible endoscope. Arch Surg 2009;144:734-738.

    21 Curcillo PG 2nd, Wu AS, Podolsky ER, Graybeal C, Katkhouda N, Saenz A, et al. Single-port-access (SPA) cholecystectomy: a multi-institutional report of the first 297 cases. Surg Endosc 2010;24:1854-1860.

    22 Hernandez JM, Morton CA, Ross S, Albrink M, Rosemurgy AS. Laparoendoscopic single site cholecystectomy: the first 100 patients. Am Surg 2009;75:681-686.

    23 Froghi F, Sodergren MH, Darzi A, Paraskeva P. Singleincision Laparoscopic Surgery (SILS) in general surgery: a review of current practice. Surg Laparosc Endosc Percutan Tech 2010;20:191-204.

    March 1, 2010

    Accepted after revision August 30, 2010

    Author Affiliations: Research Institute of General Surgery, Jinling Hospital, Nanjing University School of Medicine, Nanjing 210002, China (Ji W, Ding K, Yang R, Liu XD, Li N and Li JS)

    Jie-Shou Li, MD, PhD, Research Institute of General Surgery, Jinling Hospital, Nanjing University School of Medicine, Nanjing 210002, China (Tel: 86-25-84826808; Fax: 86-25-84803956; Email: jydmd@ yahoo.com.cn)

    ? 2010, Hepatobiliary Pancreat Dis Int. All rights reserved.

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