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 ¤ Introduction
 ¤  Materials and Me...
 ¤ Results
 ¤ Discussion
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 Table of Contents     
ORIGINAL ARTICLE
Year : 2012  |  Volume : 8  |  Issue : 3  |  Page : 74-78
 

Single-port transumbilical laparoscopic cholecystectomy: A prospective randomised comparison of clinical results of 140 cases


1 Department of General Surgery, Universitary Hospital Vall d'Hebron, Barcelona, Spain
2 Istanbul University, Istanbul Faculty of Medicine, Turkey

Date of Submission04-Dec-2010
Date of Acceptance23-Mar-2011
Date of Web Publication29-Jun-2012

Correspondence Address:
Ramon Vilallonga
Department of General Surgery, Universitary Hospital Vall d'Hebron, Passeig de la Vall d'Hebron, 119-129, 08035 Barcelona
Spain
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-9941.97586

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 ¤ Abstract 

Introduction: A novel single port access (SPA) cholecystectomy approach is described in this study. We have designed a randomised comparative study in order to elucidate any possible differences between the standard treatment and this novel technique. Materials and Methods: Between July 2009 and March 2010, 140 adult patients with gallbladder pathologies were enrolled in this multicentre study. Two surgeons (RV and UB) randomised patients to either a standard laparoscopic (SL) approach group or to an SPA cholecystectomy group. Two types of trocars were used for this study: the TriPort TM and the SILS TM Port. Outcomes including blood loss, operative time, complications, length of stay and pain were recorded. Results: There were 69 patients in the SPA group and 71 patients in the SL group. The mean age of the patients was 43.2 (17-77) for the SPA group and 42.6 (19-70) for the SL group. The mean operative time was 63.9 min in the SPA group and 58.4 min in the SL group. For one patient, the SPA procedure was converted to a standard laparoscopic technique and to open approach in the SL group. Complications occurred in eight patients: Five seromas (two in the SPA group) and three hernias (one in the SPA group).The mean hospital stay was 38.5 h in the SPA group and 24.1 h in the SL group. Pain was evaluated and was 2 in the SPA and 2.9 in the SL group, according to the visual analogue scale (VAS) after 24 h (P<0.001). The degree of satisfaction was higher in the SPA group (8.3 versus 6.7). Similar results were found for the aesthetic result (8.8 versus 7.5). (P<0.001). Conclusion: Single-port transumbilical laparoscopic cholecystectomy can be feasible and safe. When technical difficulties arise, early conversion to a standard laparoscopic technique is advised to avoid serious complications. The SPA approach can be undertaken without the expense of additional operative time and provides patients with minimal scarring. The cosmetic results and the degree of satisfaction appear to be significant for the SPA approach.


Keywords: Cholecystectomy, single-incision laparoscopic surgery, single port access


How to cite this article:
Vilallonga R, Barbaros U, Sümer A, Demirel T, Fort JM, González O, Rodriguez N, Carrasco MA. Single-port transumbilical laparoscopic cholecystectomy: A prospective randomised comparison of clinical results of 140 cases. J Min Access Surg 2012;8:74-8

How to cite this URL:
Vilallonga R, Barbaros U, Sümer A, Demirel T, Fort JM, González O, Rodriguez N, Carrasco MA. Single-port transumbilical laparoscopic cholecystectomy: A prospective randomised comparison of clinical results of 140 cases. J Min Access Surg [serial online] 2012 [cited 2019 Dec 11];8:74-8. Available from: http://www.journalofmas.com/text.asp?2012/8/3/74/97586



 ¤ Introduction Top


Improvements in laparoscopic techniques have allowed surgeons to perform complicated intra-abdominal surgery with minimal trauma. Many operations have already been standardised, even for the treatment of cancer.

Langenbuch undertook the first cholecystectomy in 1882 through a subcostal incision. His technique became the standard of care, and remained essentially unchanged for over a century. Phillipe Mouret was credited with the first laparoscopic cholecystectomy using video technology in 1987. Nowadays, the use of minimally invasive surgery has increased. [1] A new era has opened up with recent innovations that have pioneered the use of single-incision laparoscopic surgery (SILS), or single port access (SPA). This novel technique or approach is located somewhere between pure natural orifice transluminal endoscopic surgery (NOTES), hybrid NOTES and standard laparoscopic surgery. [2],[3],[4],[5] According to evolution, NOTES should be the final difficult frontier for the minimally invasive revolution: surgery without incisions. [6],[7]

This new approach seems to reduce the trauma of surgical access with its improvements in postoperative pain and cosmetic results. However, other important issues must be critically analysed, such as how time consuming it is and what complications and difficulties are involved in performing this novel technique.

For these reasons, and in order to implement SPA cholecystectomy and to know which difficulties, limitations and advantages are involved, we decided to conduct this study. The aim of the study was to determine whether or not SPA can offer a similar operative time, length of hospital stay and complication profile with improved cosmetic results and less postoperative pain in comparison to traditional multiport, multi-incision laparoscopic cholecystectomy, also called standard laparoscopic cholecystectomy.


 ¤ Materials and Methods Top


Between July 2009 and March 2010, 140 adult patients with gallbladder pathologies were enrolled in this multicentre study. Two surgeons (RV and UB) enrolled patients and randomised them into the two different groups by each surgeon in an alternative way. In this study, all patients underwent SPA cholecystectomy or standard laparoscopic (SL) cholecystectomy. All interventions were only performed by the two surgeons, at Vall d'Hebron Universitary Hospital (Barcelona, Spain) and at Istanbul University, Istanbul Faculty of Medicine (Istanbul, Turkey). All of the patients were informed about the intervention technique to be used on them and provided written informed consent. All of the patients had documented gallstones. The patients included in the study were recruited from patients undergoing elective surgery and urgent surgery in the emergency room.

Operative techniques

A single intra-umbilical 22 mm incision was made and the umbilicus was pulled out, exposing the fascia in the SPA Group (SPAG). The surgeons in this study completely extroflexed the umbilicus and a 1.5-2 cm skin incision was made longitudinally. Two types of trocar were used in the SPAG that were manufactured for this purpose: the TriPort TM (Advanced Surgical Concepts, Wicklow, Ireland) and the SILS TM Port (Covidien, Inc., Norwalk, CT, USA). For the patients included in the SL group (SLG), a Jason trocar and standard trocars were used. All trocars were placed under direct vision. The pneumoperitoneum was maintained at 12 mmHg with carbon dioxide (CO 2 ). The abdominal cavity was explored using a 10 mm 30° standard scope in both groups. No sutures at the fundus were used to suspend the gallbladder from the abdominal wall. The gallbladder was emptied by means of a hook perforation and aspiration. The patient was placed in an anti-Trendelenburg position and rotated to the left, as in standard laparoscopic cholecystectomy.

In some patients, one or two roticulated instruments were used to create the necessary operative angle in the SPAG and to minimise sword fighting (Roticulator Endo Mini-Shears, Autosuture, Norwalk, CT, USA and Roticulator Endograsp, 5 mm, Autosuture, Norwalk, CT, USA). Dissection was performed as a normal retrograde cholecystectomy in both groups.

The cystic artery and duct were first exposed, then separately clipped using a standard 5 mm or 10 mm clip applier (Endoclip 5 mm clip applier or Endoclip 10 mm clip applier; Autosuture) and excised.

Then, in the SPAG, a 5 mm 30° standard scope was used to extract the gallbladder with a standard Endocatch (Endocatch Gold, 10 mm; Autosuture). The gallbladder was also extracted using a standard Endocatch (Endocatch Gold, 10 mm; Autosuture) through the umbilical site in the SLG, but without removing the 10 mm 30° standard scope. Careful control of homeostasis was then achieved, and drainage tube was left in place according to the surgeon's personal criteria. The fascial incisions were closed with an absorbable suture and the umbilicus was restored to its physiologic position using absorbable cutaneous stitches. The rest of the skin incisions were closed with absorbable cutaneous stitches.

Intraoperative complications, bleeding, drain placement, surgical times (trocar(s) placement, surgical dissection and closure) were calculated. Other operative data and postoperative complications were analysed. Any pain reported by the patients after 12 h was measured using a visual analogue scale. [8] All patients received paracetamol, 1 g/8 h i.v., as a standard analgesic treatment. At one month after surgery, in the outpatient clinic, the patients answered two questions: "How satisfied with the surgery are you? (0-10)0" and "How satisfied are you with the cosmetic result of the surgery? (0-10)". These short questions were asked to determine the degree of satisfaction with the surgery and with the cosmetic results. Furthermore, during follow-up in the outpatient clinic, other data such as the presence of hernias or other complications were evaluated. The patients were evaluated every three months for the time of the study.

Statistical analysis

Statistical analysis was performed using the Statistical Package for the Social Sciences (v. 13.0, SPSS, Chicago, IL, USA); P < 0.05 was considered as significant. Associations between continuous variables were assessed using one-way ANOVA.


 ¤ Results Top


There were 69 patients in the SPA group and 71 patients in the SL group. The mean age of the patients was 43.2 years (SD 14.6) for the SPA group and 42.6 years (SD 14.6) for the SL group. There were 31 males and 38 females in the SPA group and 35 males and 36 females in the SL group [Table 1]. The SILS TM Port was used in 63 patients and the TriPort TM in 6 patients. In the SL Group, 11 mm and 5 mm Jason trocars were used in 34 patients and two 5 mm and one 11 mm Jason trocars were used in 37 patients. The mean operative time was 63.9 min in the SPA group and 58.4 min in the SL group [Table 2].
Table 1: Demographic data of the single port access group and the standard laparoscopic group

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Table 2: Results concerning operative technique

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For one patient, the procedure was converted to a standard laparoscopic technique due to technical difficulties in the SPA group and to open in the SL group. Complications related to the surgery occurred in eight patients; five seromas (two in the SPA group and three in the SL group) and three hernias (one in the SPA group and two in the SL group).

The mean hospital stay was 38.5 h in the SPA group and 24.1 h in the SL group.

Pain was evaluated and was 2 in the SPA and 2.9 in the SL group, according to the VAS after 24 h, and was treated with a standard analgesic dose (paracetamol 1 g/8 h i.v) (P<0.001). The degree of satisfaction, at the one month follow-up, was higher in the SPA group (8.3 versus 6.7) (P<0.001). Similar results were found for the aesthetic result (8.8 versus 7.5) (P<0.001). The mean follow-up was 7.3 months [Table 3].
Table 3: Postoperative results

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 ¤ Discussion Top


Laparoscopic cholecystectomy has been recognised since 1992 as the gold standard procedure for gallbladder surgery. Also, many surgical research groups have been practicing a new surgical technique called natural orifice translumenal endoscopic surgery (NOTES). [9] Some cholecystectomies have even been performed through a vaginal approach, with no visible scars. [10] However, many authors consider the umbilicus as a natural orifice due to its origin. Also, the umbilicus is a well-known and standardised site for access to the abdominal cavity for laparoscopic procedures. [11] However, many authors have described SPA cholecystectomy as a step towards less invasive surgical procedures. [12] According to the experience of the surgeons in the present study, umbilical access does not add new risks and it makes the operating view the same as in standard laparoscopic cholecystectomy. No differences were found when comparing the trocar placement time of each group, and all of the trocars were placed under direct vision.

It is often necessary to use a large clip in a 10 mm instrument rather than the medium-large clip found in most 5 mm clip appliers. For this reason, it may be necessary to change a 5 mm optic to a 10 mm optic. When the fascia is exposed, it is possible to enter the abdominal cavity using various devices, such as 10 mm trocar and two 5 mm trocars. The single-port technique allows easy use of a 10 mm instrument if needed without the burden of having to work with a 5 mm and a 10 mm port so close together. The cephalad retraction of the gallbladder is still sometimes difficult but provides a clear vision of the typical triangle with which most surgeons are familiar. [9]

The opinion of the authors concerning the visualization in this series was not as optimal as with typical laparoscopy. For this reason, some authors have described the possibility of using the suture retraction method, which has been shown to be feasible. [13] Although this could not eliminate the difficulties completely, it did provide some solutions in many cases. The authors of this study did not use this retraction method. In cases of suboptimal cephalad retraction, important attention must be taken when using the single-incision technique.

A very important issue to consider is the conversion from the single-incision technique to the standard laparoscopic technique. Often, the limiting factors of poor visibility and intraoperative complications are due to inadequate visualization of Calot's triangle. For this reason, we consider that a two-port or three-port conversion should not be considered as a failure or complication. This concept is very important and is absolutely mandatory in urgent gallbladder surgery.

The authors cannot stress enough the importance of conversion to a traditional four-port procedure if necessary, as we did for two patients (one to a standard laparoscopic approach and another to a needlscopic instrument). Also, it must be possible to leave a drain in place whenever the surgeon considers this to be important. No data were found concerning drains in the literature. We left 50% more drains in the SPA group compared to the SLG (12 versus 6). This can be explained by the lack of confidence of the surgeon with the technique or the learning curve.

It seems reasonable to think that the benefits of the transition from the standard laparoscopic approach to SPA will not be as obvious as the benefits from the transition from open to laparoscopic cholecystectomy were. Also, a critical view must be achieved. If this is not realised, then the addition of ports is recommended in order to achieve an adequate critical view. The suture retractors used to elevate the dome of the gallbladder can only be placed at the level of the right costal margin, as with needlscopic instruments.

However, the SPA approach is feasible with standard and slightly modified instruments for standard laparoscopic cholecystectomy, thus posing minimal additional challenges to the laparoscopic surgeon. Accordingly, we believe that the use of this approach for cholecystectomy is worthwhile. We believe that surgeons with significant experience in advanced laparoscopy should perform this technique. New devices and new technology is available at the time of writing that makes this technique easier. However, this technique can be difficult and very dangerous if meticulous and early conversion is not maintained.

Concerning the aesthetic results, at the end of the procedure the surgeons took time to perform a careful reconstruction of the umbilicus. Depending on which kind of umbilical incision was made (infraumbilical or transumbilical), access to the abdominal cavity and umbilicus reconstruction are different. The transumbilical approach can offer direct access to the abdominal cavity, whereas the infraumbilical approach requires opening up the fascia and the preperitoneal fat. Furthermore, extreme care must be taken when closing these two incisions. The transumbilical approach may seem easier but it is very important to avoid any kind of asymmetric suture when closing the skin with reabsorbable suture or non-reabsorbable sutures. Patients take a lot of care of the umbilicus and consider its reconstruction to be one of the most important end points of the whole surgery (even if the surgery was demanding because of chronic cholecystitis, for example). In our study, the cosmetic results showed that there is a certain advantage to performing single-incision surgery compared to the standard procedure. However, the understanding of the question could have been biased because some of the patients tended answer the question " Are you happier to have four holes or one hole? For this reason, we insisted a lot in the sense of the question, and we even created two questions to compare both aspects ("How satisfied with the surgery are you? (0-10)" and "How satisfied are you with the cosmetic result of the surgery? (0-10)"). The patients seemed to be satisfied with the overall result and with the aesthetic result. However, this is a difficult subjective opinion and difficult to measure. These two results seem to show a good indication, or at least a reason, of why it would be interesting to have SPA surgery versus the laparoscopic approach. Some recent data on pyeloplasty procedures in SPA surgery showed the same results according to the aesthetic but not the clinical outcome. [14]

There was a similar postoperative management of both groups in the present study. In terms of complications, a biliary leak from an accessory Lushka duct has already been reported. [15] Many authors have found SILS cholecystectomy to be feasible, safe, and effective. [9],[10],[11],[12],[13] The authors of the present study also believe that single-incision laparoscopic cholecystectomy is feasible. However, it must be stated that it may not be as safe as traditional laparoscopic cholecystectomy. Many authors observed a decrease in the operating time, even from more than 3 h to 50 min, whereas others observed an average operative time of 162 min. [11] In the present study, the surgical times ranged from 25 to 110 min. Also, the learning curve seemed to be around 10 cases in the hands of a fellowship-trained laparoscopic surgeon. [16]

It must be noted that this study is the first to include patients from the emergency department with acute cholecystitis. This added technical problems but it was feasible. However, SPA surgery should not be recommended in all cases and a standard laparoscopic approach avoiding major complications should be preferred.

Some authors have tried to encourage the use of these minimally invasive techniques in order to reduce the risk of bleeding, organ damage and incisional hernias from trocar placement. However, it cannot be overstated that every additional incision and trocar placement increases such risks, according to our results. We believe that surgeons with significant experience in advanced laparoscopy should perform this technique. New devices and new technology is available at the time of writing that will make this technique easier. However, this technique can be difficult and very dangerous if meticulous and early conversion is not maintained.

Recent technological developments have enabled a wider acceptance of new approaches in laparoscopic surgery, such as SPA cholecystectomy. All recent data show that this technique is feasible and safe, but new randomised studies are required in order to clarify its indications.


 ¤ Conclusion Top


Single-incision laparoscopic surgery is a feasible way of performing cholecystectomy. Many authors have reported their previous experiences. Adding a right lateral port to retract the gallbladder resolves technical problems related to visualisation and bleeding from clipping. From our experience, conversion to a four-port operation should be performed in any case when optimal or suboptimal conditions for safety are not present. Acute cholecystitis patients should not be selected. The cosmetic results and the degree of satisfaction after the surgery appeared to show the benefits of the SPA approach compared to SL. This last item is important for our knowledge base because it shows a clear and different indication for this surgery compared to the standard laparoscopic approach and the single-pot access approach.

 
 ¤ References Top

1.Lukovich P, Kupcsulik P. NOTES and other minimally invasive surgical techniques (hybrid NOTES, NOTUS, SPS, SILS), and their effect on surgical approaches. Magy Seb 2009;62:113-9.  Back to cited text no. 1
    
2.Giday SA, Kantsevoy SV, Kalloo AN. Principle and history of Natural Orifice Translumenal Endoscopic Surgery (NOTES). Minim Invasive Ther Allied Technol 2006;15:373-7.   Back to cited text no. 2
    
3.Seven R, Barbaros U. Needloscopy-assisted transvaginal cholecystectomy. Surg Laparosc Endosc Percutan Tech 2009;19:61-3.  Back to cited text no. 3
    
4.Marescaux J, Dallemagne B, Peretta S, Wattiez A, Mutter D, Coumaros D. Surgery without scars: Report of trans luminal Cholescystectomy in a human being. Arch Surg 2007;142:823-6.  Back to cited text no. 4
    
5.Zehetner J, Wayand WU. Notes-A new era? Hepatogastroenterology 2008;55:8.  Back to cited text no. 5
    
6.Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg 2009;13:188-92.  Back to cited text no. 6
    
7.Palanivelu C, Rajan PS, Rangarajan M, Parthasarathi R, Senthilnathan P, Praveenraj P. Transumbilical flexible endoscopic cholecystectomy in humans: First feasibility study using a hybrid technique. Endoscopy 2008;40:428-31.  Back to cited text no. 7
    
8.Benhamou D. Evaluation of postoperative pain. Ann Fr Anesth Reanim 1998;17:555-72.  Back to cited text no. 8
    
9.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;24:2241-7.  Back to cited text no. 9
    
10.Pugliese R, Forgione A, Sansonna F, Ferrari GC, Di Lernia S, Magistro C. Hybrid NOTES transvaginal cholecystectomy: Operative and long-term results after cases. Langenbecks Arch Surg 2010;395:241-5.  Back to cited text no. 10
    
11.Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: Surgery without a visible scar. Surg Endosc 2009;23:896-9.  Back to cited text no. 11
    
12.Vilallonga R, Stoica RA, Cotirlet A, Armengol M, Iordache N. Single incisión laparoscopic surgery (SILS) cholecystectomy. A novel technique. Chirurgia (Bucur) 2010;105:239-41.   Back to cited text no. 12
    
13.Roberts KE, Solomon D, Duffy AJ, Bell RL. Single-incision laparoscopic cholecystectomy: A surgeon's initial experience with 56 consecutive cases and a review of the literature. J Gastrointest Surg 2010;14:506-10.  Back to cited text no. 13
    
14.Stein RJ, Berger AK, Brandina R, Patel NS, Canes D, Irwin BH, et al. Laparoendoscopic single-site pyeloplasty: A comparison with the standard laparoscopic technique. BJU Int 2011;107:811-5.  Back to cited text no. 14
    
15.Chow A, Purkayastha S, Paraskeva P. Appendicectomy and Cholecystectomy Using Single-Incision Laparoscopic Surgery (SILS): The First UK Experience. Surg Innov 2009;16:211-7.  Back to cited text no. 15
    
16.Solomon D, Bell RL, Duffy AJ, Roberts KE. Single-port cholecystectomy: Small scar, short learning curve. Surg Endosc 2010;24:2954-7.  Back to cited text no. 16
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]

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