During the year 2009, there were 58 SILS cholecystectomies performed in the Department of General and Minimally Invasive Surgery, University Hospital and Clinics in Olsztyn, Poland. The first 8 SILS cholecystectomies were not included in the study because surgical technique varied significantly in this initial period. During that time the team searched for the best operative technique and tried to eliminate difficulties due to the lack of experience in using SILS and imperfection of the equipment and laparoscopic instruments used. As we became more proficient in using SILS, during a relatively short period of time we managed to work out our own surgical technique and could start the planned study. All centres that introduce novel operative techniques initially qualify patients with the lowest risk potential for the occurrence of technical difficulties. This is mainly because we are all aware of the difficulties associated with gaining the necessary experience during the first few applications of a new technique. A surgeon's conviction towards a new technique frequently depends on the outcomes of these first cases. The wrong choice of the first patients leads to higher complication rates and increased frequency of conversions to classic multiport laparoscopy. Bearing this in mind, we decided to qualify patients with a low anaesthetic risk, that is, patients with their health state assessed according to the American Society of Anesthesiologists (ASA) with a score of I and II. The upper BMI limit of 35 kg/m
2 was due to concerns that there might be more technical difficulties due to the thicker abdominal wall and excess of fat tissue around the gallbladder. We were also concerned about previous abdominal surgery, as it is well known that intra-abdominal adhesions are one of the basic factors that increase conversion rates [
4–
6]. Due to the above concerns, we decided not to qualify patients who had undergone previous abdominal surgery with a scar above the umbilicus. Patients with acute cholecystitis were also excluded because of a potentially increased risk of complications due to the inflammatory effusion, oedema and necrosis that might have impacted the anatomical situation [
7].
One of the very important factors assessed during the comparative analysis of surgical techniques is total operative time. In the present study the mean operative time of SILS cholecystectomy was 66 min (range: 35-110 min). It was very close to the results of Solomon
et al.
[
8]. When they excluded the first 10 cases (mean operative time of 80 min) and performed a sub-analysis of operative times for consecutive groups consisting of 10-11 patients, they could see that the mean operative time shortened successively, being 73, 71, 58 and 65 min in the consecutive groups. These results were similar to other published series [
9–
15]. It significantly differed from the mean operative time of 47 min for multiport cholecystectomy. This difference would be much greater if we compared our results with the best achieved operative times for laparoscopic cholecystectomy published by Stephenson
et al. In his group of patients the mean operative time was 39 min (range: 25-60 min) [
16]. Certainly, the significantly longer operative time of SILS cholecystectomy in comparison to multiport laparoscopy is a weakness of the technique. However, one should remember that this technique is novel. Historically, operative times of the first 100 laparoscopic cholecystectomies published by great laparoscopic surgeons were 98 min (Zucker
et al.) and 85 min (Peters
et al.) [
17,
18]. These operative times are still longer when one compares these results with our and some other authors’ initial outcomes of SILS cholecystectomy. One can expect that this scenario will be repeated soon with significantly improved published outcomes.
The post-operative pain is the next key parameter allowing a comparative analysis of both techniques. Post-operative pain is particularly important from the patient's point of view. It is a subjective measure of suffering that influences the post-operative quality of life. It is unquestionable that the post-operative pain after laparoscopic procedures lasts significantly shorter and its intensity is reduced when compared to open techniques [
19–
22]. The introduction of SILS and further reduction of operative trauma allows us to expect further improvement of post-operative pain. The main difference between multiport and SILS cholecystectomy is the number of abdominal wall incisions; thus one would expect a reduction of pain mainly in the abdominal wall and not in its cavity. The specific time intervals for pain measurement were at 6 h and 24 h post-operatively, when the patient passed urine for the first time and was fully mobilized. The intensity of post-operative pain 6 h after surgery was significantly smaller after SILS cholecystectomy, with a mean VAS score of 3.49, when compared to multiport surgery, with a mean VAS score of 4.53 (
p = 0.00096). Similar results were published by Tsimoyiannis
et al.
[
23]. Importantly, in their study most of the patients also declared that they were ready to leave the hospital 6 h after surgery. Similar results were published by Bresadola
et al. with assessment performed at 4 h and 8 h after surgery [
24]. Similarly, a significant but smaller difference in VAS scores was seen at 24 h, with VAS = 1.18 and 1.55 (
p = 0.0187) for SILS and multiport cholecystectomy respectively. Reduction of the difference in VAS score, seen also by Tsimoyiannis
et al.
[
23], is a result of the fact that the main difference between the two techniques is the cumulative length of surgical incision. The remaining factors such as the mode of creation of pneumoperitoneum, intra-abdominal pressure, temperature and type of gases used during both techniques were identical. The larger the wound, the greater is the extent of operative trauma. Therefore, the difference in the VAS scores in favour of the SILS procedure was most clearly visible during the first 24 h after surgery. Reduced pain severity after SILS cholecystectomy was reflected in a decreased analgesic requirement during the post-operative period. Although the statistical analysis showed that the difference in analgesic requirement between groups was not significant, the
p value of 0.0737 was very close to the significance level. Similar results were published by Bresadola
et al.
[
24].
Hospitalization time might be measured in several ways. We decided to measure only the time that the patient stayed in the hospital after surgery, as the pre-operative period varies significantly depending on the activities required to prepare the patient for surgery in Polish hospital settings. The mean post-operative hospitalization time in group I was 1.33 days (range: 1-2 days) and in group II was 1.96 days (range: 1-3 days) (
p < 0.001). Therefore, in terms of post-operative hospitalization time SILS cholecystectomy is more beneficial. Similar conclusions come from most of the cited publications, although direct comparisons are difficult to make as we assessed only post-operative hospitalization time, not the total hospitalization time as did other authors [
10,
11,
13,
25–
27].
Since the introduction of laparoscopy, one of the major factors allowing assessment of its value and usefulness has been the rate of conversions. It is obvious that SILS cholecystectomy, like all previous laparoscopic procedures, had to be assessed against this parameter. In the present study there were 4 conversions (8%) in group I. Our conversion rate seems to be good when compared with previously published reports, especially since the number of patients in our group is not that small. Most of the studies with conversion rates of 0 reported on outcomes in groups of 10 to 20 patients [
13,
14,
27–
31]. Studies with a similar or greater number of patients than our study reported similar conversion rates [
8,
10–
12,
25,
32]. Edwards
et al. reported the necessity to introduce an additional 5 mm trocar in 6 cases and in 3 cases they had to convert to classic 4-port cholecystectomy in a study group of 76 patients [
12].
Only three studies reported on single cases that required conversion to an open procedure [
8,
11,
25]. All of these conversions were due to solid adhesions or inflammatory infiltration that was not amenable to laparoscopic manoeuvres. There was only 1 (2%) conversion to an open procedure in group II, which is in favour of SILS cholecystectomy that did not require such conversions. Nevertheless, one should not draw conclusions from this result as the assessment of conversions should be performed on significantly larger groups of patients.
Despite being minimally invasive, laparoscopic techniques are not free of post-operative complications. As SILS cholecystectomy is a very specific procedure, we decided to divide the complications into two groups. The first group was composed of complications that were a direct result of the course of operation and the second group was composed of complications of wound healing. There were 2 cases of right pneumothorax that occurred directly after putting the suspension suture into the gallbladder fundus via the 7
th intercostal space (7
th and 16
th operations). In these cases we decided to reduce the pneumoperitoneum to 9-10 mm Hg and we pulled the gallbladder towards the abdominal wall with more strength. At the same time the anaesthesiologist increased the O
2 concentration in the inhaled gases to 50% and corrected the ventilation to keep EtCO
2 between 30% and 35%. In both cases the undertaken measures were sufficient and allowed the procedure to be finished as planned. Neither of these 2 patients required any thoracic drainage as the control bed-side chest X-ray showed no pneumothorax at the end of the procedure. Only one study has reported such a complication so far [
33], although it seems it might be more frequent than reported. When we planned the procedure with the use of a transabdominal suspension suture we based it on the experience of Endo
et al., who placed such a suture in the intersection of the 7
th intercostal space and midclavicular line with no pneumothorax in his group of 132 patients [
34]. Based on our experience of pneumothorax in these 2 patients, in all further patients we decided to place the suspension suture in the 8
th intercostal space and slightly lateral to the midclavicular line.
Another complication seen in our set of patients was the omission of the opened Luschka duct with subsequent choleperitonitis. In our opinion the bile leak was due to the gallbladder punctures caused by the suspension suture and our relatively small experience in this type of procedure (17 operations). That misled the surgeon about the origin of the bile leak and prevented the search for the leakage. Similar problems were encountered by the teams of Solomon
et al. and Edwards
et al.
[
8,
12], but in their cases endoscopic exploration, bile duct stenting and percutaneous drainage of the peritoneal cavity was sufficient. We did not encounter such a complication in group II. Available literature shows that the rate of bile leaks after classic multiport cholecystectomy varies between 1% and 3% [
35–
41]; thus our 2% leak rate after SILS cholecystectomy is comparable with other centres.
We observed 4 cases (8%) of wound complications in group I. The first patient with a wound complication had marginal necrosis of the umbilical skin (4th patient). On the 7th postoperative day the patient had a necrectomy done and the wound was left to heal via granulation. Two other patients had seroma formations in the umbilical wounds. In 1 patient, drainage on the 4th postoperative day was sufficient to heal the wound. In the other case, the exudate was present for 3 weeks after drainage and formed a granuloma the size of a pea. It was later excised together with one of the fascial sutures under local anaesthesia with good results. One patient had a wound infection that required opening of the wound and delayed healing via granulation.
In group II there was 1 (2%) umbilical wound infection, which corresponds to the rates published by other authors [
42]. Subanalysis of wound complications showed that although the complication rate in group I was 8%, which seemed much higher than 2% for group II, it was only true for the first subset of patients (
n = 25 in each group). In the remaining half of study patients the frequencies of wound complications were equal (). We think that this phenomenon was caused by the effect of the learning curve associated with the SILS technique, wound closure and recreation of the umbilicus. Most studies did not report on wound complications after SILS cholecystectomy [
8,
10–
15,
26,
27,
30,
43]. Just a few authors had no complications [
29,
44,
45] and only Tacchino
et al. reported a single case of periumbilical haematoma that was evacuated on the 7
th postoperative day, which allowed for wound healing [
28].
Nowadays, laparoscopic cholecystectomy is the gold standard in the treatment of gallbladder disorders. It is also one of the most frequently performed surgical procedures worldwide. Although it is a minimally invasive procedure, it leaves a few small scars on the abdominal surface. Single-incision laparoscopic surgery is a novel laparoscopic method that potentially allows for the removal of the gallbladder without leaving any new abdominal scars. Another benefit of this technique is the avoidance of typical complications of trocar sites such as trocar site hernias and trocar site bleeding into the abdominal cavity that frequently requires reoperation. Undoubtedly, SILS cholecystectomy is more difficult than the classic multiport procedure, which is reflected by longer operative times. This technique requires perfect team cooperation and dexterity in laparoscopic procedures. However, the constantly increasing number of publications on SILS procedures suggests that the SILS technique will gain wide acceptance soon and it will become a standard procedure especially in young patients with BMI up to 35 kg/m2 with no active inflammation and no serious co-morbidities. We also hope that the interest and high activity of manufacturers of laparoscopic equipment will support the progress of surgery via a single incision in the umbilicus and eliminate difficulties encountered during the implementation of this technique.