Abstract
Abstract
Background:
Recent reports have suggested that single-incision laparoscopic cholecystectomy (SILC) is technically feasible. We present our initial retrospective comparative study between SILC and conventional laparoscopic cholecystectomy (CLC) with respect to perioperative outcomes.
Methods:
The authors reviewed 100 SILC and 100 CLC performed by a single surgeon from May 2009 to July 2010 at the Shengjing Hospital of China Medical University. All the procedures were completed by using the standard trocars and rigid laparoscopic instruments. Demographic data, operating time, estimated blood loss, analgesics requirements, days to oral food intake, and complications were compared.
Results:
Of the attempted SILC cases, 99 cases (99%) were successfully performed, with 1 case requiring three additional trocars for safe dissection because of existence of accessory bile duct. In the CLC group, all the procedures were successfully completed (three trocars) without conversion to open cholecystectomy. Compared with the CLC group, there was a lower mean estimated blood loss (17.9 ± 15.8 mL versus 27.5 ± 13.9 mL; P = .000) and analgesic requirement (10 versus 23; P = .024) in the SILC group. However, there was no difference between SILC and CLC in operating time (53.5 ± 24.0 minutes versus 49.2 ± 13.8 minutes; P = .163), days to oral food intake (1.8 ± 0.8 days versus 1.8 ± 0.7 days; P = .873), and postoperative complication rate (2% versus 0%; P = .155).
Conclusion:
SILC is feasible using the standard trocars and rigid laparoscopic instruments, and it is an effective alternative to CLC in selected patients. However, further clinical studies are necessary to confirm its real benefits.
Introduction
In this pilot study, we present our clinical experience with single-incision laparoscopic technique for cholecystectomy using the standard rigid laparoscopic instruments and retrospectively compared the perioperative results of SILC with those of conventional LC (CLC) to evaluate the potential benefits of SILC.
Patients and Methods
Patient selection
We retrospectively reviewed the medical data of patients who underwent SILC and CLC between May 2009 and July 2010 at the Shengjing Hospital of China Medical University. All the patients were diagnosed by comprehensive history, supporting laboratory and ultrasound examination. As we are at the beginning of this procedure, exclusive criteria for both SILC and CLC groups included patients who had history of major upper abdominal surgery, sign of acute cholecystitis, and the American Society of Anesthesiology grade more than II, to ensure safety and avoid bias. Informed consents for the procedure were obtained from all the patients.
Surgical technique
In both groups, the anesthetic protocol, patient position, and pneumoperitoneum establishment were the same. The operative procedures were performed by a single surgeon with the use of standard trocars and rigid laparoscopic instruments, but varied trocar locations.
For the CLC group, we used three trocars in the following arrangement: a 10-mm trocar within the umbilicus, a 10-mm trocar below the xyphoid process, and a 5-mm trocar in the right upper abdomen two fingerbreadths below the right coastal margin in the anterior axillary line. The dissection was performed using ultrasonic coagulating shear (Harmonic Ace; Ethicon Endo-Surgery, Cincinnati, OH) in a combined antegrade and retrograde technique.
For SILC group, three trocars were placed in a reverse triangular configuration within the umbilicus, leaving a small bridge of fascia between each trocar. Dissection was carried out using the ultrasonic coagulating shear in a retrograde fashion. The 10-mm laparoscope was replaced by a 5-mm laparoscope for visualization after the gallbladder had been dissected from the liver bed and the cystic artery and duct were clearly identified. The cystic artery and duct were carefully clipped proximal to the gallbladder with a standard 10-mm clip applier, followed by a thorough examination for active bleeds or visceral injuries including the liver, common bile duct, and duodenum. Once the gallbladder was free, it was extracted through the incision together with the 10-mm trocar.
Outcomes and statistical analysis
Demographic data (sex, age), operating time, estimated blood loss, analgesics requirement, days to oral food intake, and complications (within the first month of surgery) were recorded and compared. The Mann–Whitney U test and χ2 test were used for statistical analysis where appropriate. Statistical significance was set at P < .05, and all reported P values are two sided.
Results
Two hundred patients were enrolled in this study (100 patients in each group), including 72 men and 128 women. The age was similar (46.2 ± 13.0 years versus 49.7 ± 13.8 years; P = .081) between the SILC and CLC groups, but there were more women in the SILC group (75% versus 53%; P = .001). Of the attempted SILC cases, one case was converted into four-trocar CLC for safe dissection because of existence of accessory bile duct, whereas the rest of the patients and all the cases in the CLC group were successfully completed. Two types of postoperative complications were encountered in this study, bile leak (n = 1) and surgical site hematoma (n = 1), which were only observed in the SILC group. No complication occurred in the CLC group. Overall postoperative complication rates were 2% in the SILC group and 0% in the CLC group, which was not statistically significant (P = .155).
There were no differences between SILC and CLC in terms of operating time (53.5 ± 24.0 minutes versus 49.2 ± 13.8 minutes; P = .163) and days to oral food intake (1.8 ± 0.8 days versus 1.8 ± 0.7 days; P = .873). However, the SILC group noted a lower mean estimated blood loss (17.9 ± 15.8 mL versus 27.5 ± 13.9 mL; P = .000) and less analgesic requirement (10 versus 23; P = .024).
The results are summarized in Table 1.
CLC, conventional laparoscopic cholecystectomy; SILC, single-incision laparoscopic cholecystectomy.
Discussion
The advent of laparoscopy has revolutionized the methods of many general surgical procedures. Current innovations in technique and instrumentation have pushed minimally invasive surgery into less-invasive but more cosmetic approaches: SILS and natural-orifice transluminal endoscopic surgery (NOTES) are being developed. However, human experience with NOTES is largely limited because of its inherent difficulties. 5 Conversely, SILS not only combines the benefits of cosmesis as NOTES, but also has the advantages of a lower complexity for clinical application and the allowance of using standard laparoscopic instruments, which promote its current widespread use.
SILC was described as early as 1997 by Navarra et al., who performed this procedure via two transumbilical trocars and three transabdominal gallbladder stay sutures. 6 Since then, the technique has been applied to many surgical procedures, including appendectomy,7,8 colectomy,9–11 and bariatric procedures such as gastric banding 12 and sleeve gastrectomy.13,14 Initial case reports and noncontrolled series from multiple institutions have indicated that SILC is a feasible alternative to CLC. However, to better define the true benefits of this technique, it is necessary to compare perioperative outcomes between patients undergoing SILC and those undergoing CLC. To date, only a few related studies have been reported: Philipp and his colleagues described their initial experience with SILC in comparison with concurrent patients undergoing CLC. In their 51 cases study, operative time was significantly longer in the SILC cases, and there was a tendency toward greater postoperative pain in the SILC group. No substantial difference in complications was identified. 15 Tsimoyiannis et al. reported their study on different pain scores in 20 SILC versus 20 CLC in 2009, and their study demonstrated that significantly lower pain scores were observed in the SILC group after the first 12 hours for abdominal pain and after the first 6 hours for shoulder pain. Moreover, requests for analgesics were significantly less in the SILS group. 16 These two studies are quite instructive even though the conclusions were incompatible.
In our study, we attempted to perform a retrospective comparison of SILC and CLC by a single experienced surgeon with a relatively large number of samples. In patient and surgeon selection, we hoped to minimize the potential for selection bias between each group. Interestingly, despite this study representing our initial SILC experience, we noted that although the mean operating time was numerically longer in the SILC group than that in the CLC group, this difference between each group was not statistically significant (P = .163). This insignificance is attributable to all the procedures being performed by an experienced and skilled laparoscopic surgeon who had previously completed 10 SILC with SILS™ procedure kit, which were not included in this study. This may have helped shorten the learning curve with standard trocars and rigid laparoscopic instruments. Two types of complications were encountered in the SILC group though statistically insignificant. Bile leak (n = 1) from an accessory bile duct was observed in a patient in the SILC group and was converted to four-trocar CLC. One case of surgical site hematoma was also observed after the patient was discharged. Follow-up information from outpatient clinic visits at 1–3 months postoperatively was available for these two patients, and both surgical complications improved with conservative treatment. Although we did not define cost factors associated with each of the techniques, such as disposable surgical supplies and item costs from the operating room, both procedures were performed using the same instrumentation in the same operating room setup, so it was inferred that the operative costs between the SILC and CLC groups were approximately equal.
This pilot study has several limitations. First, there were significantly more female patients in the SILC group, which may lead to bias. However, SILC has a definite cosmetic advantage; therefore, surgeons are more likely to offer it to female patients, with more female patients in our study preferring this technique. We hope that gender-related difference will be better evaluated in future works with larger number of samples. Second, although the body mass index of patients was an important factor in the demographic characteristics for comparison, we did not record body mass index for some patients in the CLC group who underwent CLC procedure before we began to attempt the SILC procedures, so this factor was not included in our study. Third, the optimal means of assessing postoperative pain would involve using a visual analog scale (VAS) as well as measuring analgesic requirement as described in Tsimoyiannis' study. However, we do not routinely use a VAS to assess pain. Fourth, the metrics of hospital stay after surgery was not used in our study. Length of postoperative hospital stay depends on other hospital and patient factors including regulations from medical insurance companies, some of which have no direct relation to the clinical status of the patient. As a result, we do not consider postoperative hospital stay as a proper measure of the operative technique. Instead, we chose “days to oral food intake” as a more reliable element for comparison.
Conclusion
At present, SILS is a growing trend in minimally invasive surgery. In our retrospective study, SILC is a feasible and equally efficacious technique with reduced postoperative pain to CLC in the hands of an experienced laparoscopic surgeon. However, this technique is in its infancy, and there are only few data confirming the benefits of this approach. Further studies are required with larger groups of patients and validated outcome measurements (e.g., VAS and cosmetic surveys) to determine whether there are clear advantages to this novel surgical technique.
Footnotes
Disclosure Statement
No competing financial interests exist.