Transumbilical single incision laparoscopic cholecystectomy with conventional instruments: A continuing study.

INTRODUCTION: The feasibility of the single incision, multiport transumbilical approach(SILC) for the treatment of symptomatic gallbladder calculus disease has been established. AIMS: The study examines both short and long term morbidity of the SILC approach.
MATERIALS AND METHODS: All the 1338 patients were operated by the same surgeon through a transversely placed umbilical incision in the upper third of the umbilicus. Three conventional ports,10,5 and 5 mm were introduced through the same skin incision but through separate transfascial punctures. The instruments were those used for standard laparoscopic cholecystectomy(SLC).Patients with acute cholecystitis and calculous pancreatitis were included,while those with choledocholithiasis were excluded. Results were compared with those of SLC.
RESULTS: Forty patients had difficult gall bladders, 214 had acute cholecystitis, and 16 had calculous pancreatitis. The mean operating time was 24.7 mins as compared to 18.4 mins in SLC. Intracorporeal knotting was required in four patients. Conversion to SLC was required in 12 patients. Morrisons pouch drain was left in 3 patients. Injectable analgesics were required in 85% vs 90% (SILC vs SLC) on day 1 and 25% vs 45% on day 2 and infection was seen in 6(0. 45%) patients. Port site hernia was seen in 2 patients. The data was compared with that of SLC and significance calculated by the student 't' test. A p value less than 0.05 was considered as significant.
CONCLUSIONS: Trans umbilical SILC gives comparable results to SLC, and is a superior alternative when cosmesis and postoperative pain are considered, but the operative time is significantly more.

INTRODUCTION

The increasing spate of reports in reputed endoscopic journals bear testimony to the increasing acceptance of the single incision laparoscopic approach. This is understandable, especially because the technique, which is a slight modification of the standard laparoscopic approach, is easily learnt and is on familiar terrain of standard laparoscopic infrastructure including standard instruments. The question why at all shift to this method still remains statistically unanswered and awaits Level A recommendation. After our initial report[1] documenting the feasibility and safety of trans-umbilical single incision laparoscopic cholecysectomy (SILC), or also known as laparoendoscopic single site cholecystectomy (LESSC), we shifted to SILC as the procedure of first choice for symptomatic cholelithiasis. SILC in our unit uses only conventional rigid instruments. We set about analysing and comparing variables of SILC with those of SLC done by the same surgeon and to define the morbidity pattern of SILC.

MATERIALS AND METHODS

All patients presenting with gall bladder stone disease in our unit, from October 2009 onwards, are now being offered SILC as the primary procedure. This includes patients with all forms of presentations of cholelithiasis including acute cholecystitis and mild acute calculous pancreatitis but excludes patients with choledocholithiasis. The patients were routinely investigated and in those with CBD(common bile duct) dilatation (6 mm or more) a computed tomography (CT) scan was carried out. Informed consent for the procedure was taken. All the patients were operated under spinal anaesthesia, a technique that has been described earlier.[2]

The approach is trans-umbilical single incision multiport technique. A 2.5-3.0 cm slightly curved transversely placed incision across the upper third of the umbilicus is deepened up to the fascia and upper flap is undermined for about 1 cm. The procedure, which is carried out at a pneumoperitoneum of 8-10 mmHg, has been described in detail earlier.[1] The scopes used are 10 and 5 mm, both 30 degrees, 10 mm clip applicator and routine standard laparoscopic instruments. The three port punctures are 1-1.5 cm apart in a transverse line [Figure 1]. The cystic artery is alternatively dealt directly with the harmonic scalpel (Ethicon Endosurgery) or the bipolar cautery or clips. Transfixing intra-corporeal knotting with 3-0 vicryl (polygalactin 910), through the same ports, was required in patients with a very wide cystic duct.[1] Gall bladder retraction when required is done with the verees needle, in the right hypochondrium.[1] Intra-operative cholangiogram was not performed in any patient.

Figure 1

Showing ports and their position at the umbilicus

The camera assistant needs to hold the camera with his left hand and has to stand cranial to the operating surgeon, instead of standing behind the surgeon as in SLC.[1] The rigid laparoscopic instruments used had their cautery attachment point at the distal end in line with the long axis of the instrument and not on the top.[1] The trans-facial holes at the umbilicus are closed carefully using 2-0 polygalactin 910 (vicryl-Ethicon endosutures) or glycocholic acid (Dexon) suture on 40 mm, 1/2 circle reverse cutting needle and the umbilicus was then reconstructed. Post-operative analgesics included injectable Tramadol 100 mg intra-muscular followed by oral diclofenac 50 mg on demand. The post-operative pain was assessed up to the time of discharge, by the visual analogue scale (VAS) in 100 patients each with SILC and SLC.

We compared the results with those of our series of SLC, which included 3492 patients. Statistical significance was calculated by the student t-test and a P value of <0.05 was considered as significant.

RESULT

Trans-umbilical SILC was attempted in 1338 patients of calculus gallbladder disease. There were no exclusions except those with choledocholithiasis and patients with gall bladder phlegmon presenting any time after the end of the 2nd week after the attack. The patients with the phlegmon were operated after 6 weeks by SILC and choledocholithiasis was always operated by standard multiport laparoscopic method. The patients were predominantly female and with an average age of 35.5 years [Table 1]. A total of 214 patients presented with acute cholecystitis, 16 patients had mild acute calculus pancreatitis and 40 patients were labelled as having difficult gall bladders [Table 2].

Table 1

SILC –Epidemiological parameters

Table 2

Difficult gallbladders

The operating time was taken as the time from the skin incision to closure of the umbilical incision. The operating time in first 20 patients, during the learning curve, varied from 28 to 66 min (avg 36.6 min) and 18–55 min (avg 24.7 min) subsequently. Our comparable time in 3 port SLC was significantly less (P < 0.01) [Table 3]. Conversion to 2 or 3 ports was required in 12 patients [Table 3]. A very short and wide cystic duct required closure with transfixation in one patient and intra-corporeal knotting with 3-0 vickryl in four patients. Intra-corporeal suturing repair of damaged right hepatic duct was done in one patient without increasing the number of ports. This patient had an uneventful recovery and the drain was removed after 48 h. Drain was also left in two other patients. Biliary leak occurred in 0.52% patients [Table 3].

Table 3

Operative parameters

No analgesic supplementation was required in 15% and 10%, respectively (SILC vs SLC), in the immediate post-operative period. Patients of SLC required injectables more frequently on day 1 and 2 (45% vs 25% in SILC). The requirement of oral analgesics was no different among the two groups. On the VAS, SILC group had 75% patients with more than 75% recovery compared with corresponding 50% in SLC [Table 4].

Table 4

Visual analogue scale (VAS) pain score

Discharge time was 1.9 days and not significantly different from SLC (2.3 days). Return to work was identical in both groups. Serosanguinous port site discharge was seen in 34 patients and infection was seen in 6 (0.45%) patients [Table 3].

The subsequent appearance of the umbilicus was cosmetically very acceptable at 4 weeks [Figure 2], because the scar was totally hidden within the folds of the umbilicus and on first inspection could not be made out. Seventy percent patients said that they would recommend this procedure over SLC. Importance of scar cosmesis varied with the background and age of the patient and those who attached no importance were those who came from a village background and were aged over 50 years.

Figure 2

Umbilicus at first month postoperative

DISCUSSION

As more and more procedures get included in the single incision laparoscopic surgery (SILS) basket, the all important question still remains partly answered. Is there any advantage of SILS approach over the standard laparoscopic surgery? Then there is the issue of re-learning laparoscopic surgery and the possible need to invest in new and costly instruments for the SILS approach. However, on the latter two counts there is minimal disadvantage as SILS is an easily learnable and performable procedure, which adheres to the principles of laparoscopic surgery albeit with a few modifications and acceptable compromises. Also the procedure can, just as easily or even more so, be performed with standard rigid laparoscopic instruments.[3456] We have been using the standard rigid laparoscopic instruments for all our SILC procedures. Cautery attachment point at the proximal end of the instrument should be in line with the long axis rather than jutting out cranially.[1]

The port accessibility does not require new, innovative and costly ports because more and more SILC procedures are being reported as using single incision multiport technique with only conventional ports.[3478] We routinely use one central 10 mm flap valve port and two flanking simple 5 mm tube ports [Figure 1]. This helps by limiting the bulk of the ports and the related clashing at the umbilicus. In our opinion and practice a 10 mm and two 5 mm ports in the same transverse line can easily be accommodated through separate trans-facial punctures in the 2.0-3.0 cm umbilical incision as the skin can be made to stretch in either direction. This is important, because if the punctures are too close, there is a chance of the holes joining each other, and then it becomes very difficult to maintain an adequate pneumoperitoneum because of the leaking gas.

The operating time for SILC was found to be significantly more than that for SLC. An inference that agrees with almost all reported studies.[9101112] This is partly a reflection of the increased operating time during the initial learning curve[13] and later the time increase because of the clashing and restricted mobility of the instruments at the very narrow umbilical fulcrum and careful closure of the umbilical ports. Although others have reported equal times for SILC and SLC after the learning curve is over.[1114] Our operating time also improved after the learning curve and experience from 36.6 min in the first 20 patients to 24.7 min subsequently, but was always significantly more than that for SLC.

We have never used stay sutures for gall bladder manipulation as in other studies[1516] for defining and dissecting the Calot's triangle. The stay sutures always result in bile leakage of varying degrees converting a clean contaminated into a contaminated operation and post-operative pain at the site of the sutures. There are studies in which, like ours, there is no puppet like suspension of the gallbladder[517] and retraction by the working instruments suffices. In this context it should be pointed out that those who have been doing and have mastered the art of three hole LC, do not require stay sutures for gall bladder manipulation. It is thus logical to suggest that before starting SILC the laparoscopist should graduate from 4 to 3 hole SLC. Adaptation to the endoscopic like end on view, of the telescope and lateral movements of the instruments with intra-corporeal crossing give a more than adequate clearance of the Calot's triangle or the “Strasberg's critical view”. The dissection of the cystic artery and the duct is then followed by either fundus first separation or retrograde separation of the gall bladder from its bed. Using instruments of different lengths helps by reducing the clashes among instrument handles, but bent or roticulating instruments are never required.

There was no selection criteria for our patients, and all patients with gall bladder stone disease were taken up for SILC, including those with empyema and acute cholecystitis. In fact, since mid-2009, every patient presenting with gall bladder disease in our unit is offered SILC as the primary procedure. All the studies to date, to the best of our knowledge, have an exclusion criteria with only patients with gall bladder colics, chronic cholecystitis or biliary sludge being taken up for SILC.[1819] Our results prove that SILC can be taken up as a routine procedure for all patients with gall bladder stones. We could successfully manage acute cholecystitis, phlegmonous gall bladder, pericholecystic abscess and difficult gall bladders [Table 2] with SILC. In fact the 12 modifications to multiport standard cholecystectomy (0.89%) that we had were in patients with chronic cholecystitis where the thick gall bladder grasping was a problem and where the xiphi-umbilical length was longer than our standard laparoscopic instruments. The common causes of conversion to SLC mentioned are inflammation, adhesions, excessive fibrosis and unclear Calot's anatomy.[16] The conversion rates reported vary from 9.3%[16] to 14.9%[12] as compared with our rate of only 0.89%. None of our patients required conversion to open cholecystectomy.

Peri-operative complication was limited to one patient where the right hepatic duct was nicked and was recognised peri-operatively and repaired by intra-corporeal suturing through the same ports. There were no other peri-operative complications. Mention has been made of gall bladder perforation or bile spillage (2.2%) and haemorrhage in 0.3% patients in various studies.[16] Post-operative biliary leak accounted for 0.52% patients and was an improvement on our earlier figure of 0.66% in our initial 756 patients.[20] The leaks were because of slipped cystic duct clips in 57.14% of the leaks. This problem was taken care of, once the malfunctioning clip applicator, which did not compress the clips optimally so that they remained loose, was changed and intra-corporeal ligation of the cystic duct was carried out in wide cystic ducts. This figure is well within the figure of 0-0.8% as reported after standard laparoscopic cholecystectomy. However, one of the patients required laparotomy for adhesive intestinal obstruction. In our series, port site discharge (2.5%) and infection (0.45%) showed non-significant difference as compared with SLC (0.40%). A recent meta analysis has quoted the figure for infection and hematoma as 2.1%.[16] Two of our patients had port site hernia, which occurred in our first batch of 50 patients. Subsequently we shifted to closure of the individual fascial punctures with the help of an aneurysm needle.[1] Since then we have had no ports site hernias in a 42-month follow-up. Reported figures for port site herniation have been inconclusive.[316]

Status of post-operative pain still remains unclear with varying reports in the literature of SILC resulting in less pain,[1418] more pain[11] or no difference[1019] as compared with SLC. Our figures suggest more pain at 24 h post-operative in SLC group.

The final operative site scar at the umbilicus is cosmetically very acceptable, because after a month of surgery the scar is hardly seen. So is this an answer to scarless surgery? But this is only possible with trans-umbilical incisions, which do not go beyond the umbilical ring as is our practice and is also mentioned in other reports.[2122] However, variations in the position of the single hole incision may not always result in a scarless result. Thus infra-umbilical incision, which been reported in many studies,[2324] or the vertical incision,[2122] although being functionally adequate, will not give as good a cosmetic result as the trans-umbilical transverse incision.

CONCLUSION

Cosmesis and pain scores were significantly better with SILC. The patient acceptance was remarkably good for the SILC. The morbidity statistics equalled those of SLC. The operative time was, however, significantly more for SILC. There is accumulating evidence giving an edge to SILC over SLC.