Is mini-laparoscopic cholecystectomy any better than the gold standard?: A comparative study.

BACKGROUND: Mini-laparoscopic cholecystectomy (MLC) has widened the horizons of modern laparoscopic surgery. Standard four port laparoscopic cholecystectomy (SLC), which has long been established as the "Gold Standard" for gall bladder diseases, is under reconsideration following the advent of further minimally-invasive procedures including MLC. Our study aims to provide a comparison between MLC and SLC and assesses whether MLC has any added benefits.
MATERIALS AND METHODS: Patients with symptomatic gall bladder disease undergoing MLC or SLC during the 2.5-month period were included in the study. Thirty-two patients underwent MLC while SLC was performed on 40 patients by the same surgeon. Data was collected prospectively and analysed retrospectively using a predesigned questionnaire.
RESULTS: In our study, both the groups had similar age, body mass index (BMI) and gender distribution. No cases of MLC required insertion of additional ports. The mean operative time for MLC was 38.2 min (33-61 min), which is longer than SLC; but it was not statistically significant. There was no significant difference in mean operative blood loss, postoperative pain, analgesia requirement and mobilization. Patients who underwent MLC were able to return to normal activity earlier than patients undergoing SLC (P < 0.01).
CONCLUSION: Our experience suggests that MLC can safely be used as an alternative to SLC. Compared to SLC, it has the added benefit of an early return to work along with excellent cosmetic results. Further large scale trials are required to prove any additional benefit of MLC.

INTRODUCTION

Ever since its origins in 1988 in the USA and France, laparoscopic cholecystectomy has fast become the gold standard for operative gall bladder removal.[12] Studies have shown that laparoscopic cholecystectomy, as compared to the previous method of open cholecystectomy, has advantages in terms of lower mortality, lesser complications and shorter length of total hospital stay.[3] This, along with better cosmesis and faster postoperative recovery allowing patients an earlier return to their daily activities made laparoscopic cholecystectomy a clear choice for gall bladder disease requiring surgical intervention.[456]

In recent years, surgeons have further been advancing the technique of standard laparoscopic cholecystectomy (SLC). The goals for newer techniques included better cosmesis, postoperative recovery times and postoperative pain by reducing the size of the instruments used during SLC. The newer instruments being developed with a <10 mm size showed initial studies claiming better postoperative pain control and cosmesis.[7]

In this study, we have evaluated and presented the benefits and drawbacks of mini-laparoscopic cholecystectomy (MLC) in comparison with SLC in terms of operative time, postoperative pain management using visual analogue scale (VAS), intraoperative blood loss, time taken for postoperative ambulation, length of patient's hospital stay, return to work and overall cost of surgery. The latter, we believe will play a large factor in a lower socioeconomic country such as Pakistan with low per capita income.[8] Using these variables, we assess if MLC may, in the future, become universally accepted as the standard of care.

MATERIALS AND METHODS

Over the time period between February-April 2014, a prospective non-randomised study was conducted on a total of 72 patients presenting to Ziauddin University Hospital, Karachi, Pakistan with symptomatic gall bladder disease. Patients were informed regarding both procedures and consent was obtained before being assigned to either MLC or SLC groups; patients were informed beforehand regarding the operative technique that would be used for their operation. The surgeon was notified at the time of scheduling the procedure regarding the method to be used. The researcher collecting the data and performing the analysis was blinded regarding the procedure performed. Preoperative percutaneous abdominal ultrasound, complete blood count and liver function tests were ordered for all patients.

For the purposes of this study, MLC was performed using three 3 mm ports and one 10 mm port, whereas SLC was performed using two 5 mm and two 10 mm ports. SLC was performed using the standard four-port technique.

Following general anaesthesia, patients undergoing MLC were placed in reverse Trendelenburg position with the surgeon on the left. A Veress needle was introduced to create pneumoperitoneum, after which a 10 mm transumbilical port and laparoscope were introduced. A specially designed stab knife of 3 mm width was used for subxiphoid, right midclavicular and right anterior axillary line incisions, followed by ports. The latter three ports were introduced under direct visualization. MLC instruments of 2.7 mm width were passed through the smaller ports. Fundus of the gall bladder retracted using gall bladder grasper; and Calot's triangle was identified and dissected using sharp dissection, keeping the use of diathermy to a minimum. Cystic duct and cystic artery were identified.

At this stage, a 2.7 mm camera was introduced through the epigastric port and a 10 mm camera was retrieved; a 10 mm clip applicator was introduced through the 10 mm umbilical port and clips were placed under direct visualization. After clip application, we switched back to visualization with a 10 mm laparoscope for dividing these structures and after dissection from the liver bed. The gall bladder was retrieved in a specimen bag through the 10-mm umbilical port. All miniports were closed with steri-strips and no sutures were applied while the umbilical port was closed with subcuticular absorbable sutures.

Approval from the ethics committee and review board was obtained prior to the start of the study. The patients' informed consent was obtained regarding both procedures and assigned to either MLC or SLC groups. Patients were aware beforehand regarding the operative technique that would be used for their operation. The surgeon knew in advance, at the time of scheduling surgery, which operative technique was to be used.

Data was collected prospectively using predesigned questionnaire and processed retrospectively using Statistical Package for the Social Sciences (SPSS) v21 (IBM, New York, USA); categorical data was calculated using chi-squared test and continuous variables using the Student's t-test. The level of significance was set at P < 0.05. Patients in neither groups experienced any significant postoperative complication and there was no loss to follow-up among the study groups. Researcher collecting data from the patient was blinded regarding the procedure.

RESULTS

The patients were divided into two groups, one undergoing MLC and the other SLC with none of our patients required to be converted from MLC to SLC. There was no loss to follow-up in either of the groups. Mean age in the MLC group was 36.4 years (19-49 years) and for the SLC group was 39.1 years (20-55 years) (P < 0.852). Gender ratio for MLC was 2:30 and for SLC was 2:38 (P = 0.645). Body mass index (BMI) again being comparable for both the groups; MLC = 24.2 (21.4-28.5) and SLC= 25.3 (20.2-30.1) (mean, min-max).

The outcome measures included mean operative times SLC: 37.5 min versus MLC: 38.2 min (P = 0.576). Other parameters compared between both techniques included: Mean blood loss MLC: 18 mL versus SLC: 21.4 mL (P = 0.258). Postoperative pain was assessed using the VAS and was found to be MLC: 1.6 versus SLC: 1.9 (P = 0.327).

Postoperative time till patients were fully mobile were assessed and found to be MLC 2.1 h versus SLC 2.7 h (P = 0.231). Furthermore, we additionally took into account the total time of the patient's hospital stay; MLC: 14.2 h versus SLC 26.4 h (P < 0.001) reaching statistical significance [Figure 1].

Figure 1

Comparison between the lengths of hospital stay

On follow-up, we evaluated the average number of days patients in both groups took to return to work and found the results to be: MLC: 2.2 days versus SLC: 3.9 days (P < 0.001) [Figure 2]. There were no significant intraoperative complications in either group and no mortalities. A comparison of costs between the two groups is presented in Figure 3.

Figure 2

Comparison of mean days required to return to routine work

Figure 3

Comparison between the cost of procedure between MLC and SLC (All figures have been converted from Pakistani Rupees to USD, according to Sep 2014 Foreign Exchange rates)

DISCUSSION

MLC was introduced in 1997 as a further advancement to SLC with the goal of enhancing the benefits of the latter.[9] Ever since then, there have been studies that support its implementation based on results pointing toward better cosmetic outcomes, less postoperative pain due to smaller instruments resulting in lesser tissue damage.[10] While at the same time, no significant increase in complications has been reported.[7] Apart from cholecystectomy, global studies have reported significant improvement in postoperative surgical pain and cosmesis using needlescopic instruments including, but not limited to, Heller myotomy, splenectomy, adrenalectomy and sigmoid resection in selected patients.[11121314]

This is the first study to be reported from Pakistan to the best of our knowledge; we have compared MLC and SLC to evaluate if MLC can become the standard of care by comparing results to SLC. In terms of total intraoperative times, the results of our MLC patients compared favourably against those reported by Lee et al.[9] 68.8 ± 31.9 min; however, this may be due to surgeon to surgeon operative time variation in that study. Our series was conducted by a single surgeon. Our operative times of SLC: 37.5 min versus MLC: 38.2 min are closest and comparable to Sarli et al.[15] of 45 (20-120) and 50 (20-170) min (LC and MLC respectively). However, difference in our operative times between SLC and MLC did not reach statistical significance (P = 0.576). Although, our intraoperative time for our first MLC patient was the longest for the entire series (61 min); this improved with time with our final results for both operative techniques being comparable.

Out of the earlier reported studies, it has been indicated that difference in intraoperative blood loss between SLC and MLC is negligible with Huang et al.[16] comparing the differences between three groups undergoing SLC, MLC and 5 mm LC and finding no statistical significance between the three groups. Our study group, when evaluated for the same parameter, reflected a similar finding and did not find a statistically significant difference between the two groups with MLC 18 mL versus SLC: 21.4 mL (P = 0.258) of intraoperative blood loss.

The variation in postoperative pain is reported differently across multiple studies according to the size of instruments used. Some series we used as comparisons include ECS by Lai et al.[17], which reports that VAS scores for trocars 3 mm or less were below 3 by 76% of patients, whereas patients in their comparison group with 5 mm trocars by 21% of patients reported significant postoperative pain (P < 0.01). Some studies suggest that despite there being a significant decrease in postoperative pain in the immediate 24 h after surgery, over the longer term there will be no significant difference in VAS in the patients who underwent SLC.[16] Novistsky et al.[18] compared postoperative pain using VAS at time intervals of: Postoperative, postoperative day 1, postoperative day 3, postoperative day 7 and postoperative day 28 and coming to a similar conclusion with only statistical significance at postoperative day 1 (P < 0.04). In our study, postoperative pain was assessed using VAS and results have shown that there was not a significant difference between the MLC and SLC groups at 24 h (P = 0.327).

The direct link between postoperative pain and incision size is not well established, with many other factors playing a role in postoperative pain including age, pressure of pneumoperitoneum and preoperative neuroticism being part of the multivariate etiology.[1920] And, therefore, even though incision size is one of the factors to reduce postoperative pain, our study shows that it is not the only factor to consider as evidenced by difference in VAS scores in both study groups not reaching statistical significance.

A secondary variable evaluated was the immediate time taken for the patient to mobilize following surgery. With studies suggesting that due to decreased postoperative pain with MLC techniques patients were able to mobilize in a lesser amount of time than those who underwent SLC.[7] In our experience, both MLC and SLC groups were able to mobilize in under 3 h with the difference between the groups not reaching statistical significance (P = 0.231).

One of the most important benefits to the patient in terms of overall health of laparoscopic cholecystectomy has been a reduced length of hospital stay and an earlier resumption of the day-to-day activities for the patient.[3] It would be logical to assume that if there is a significant reduction in postoperative pain, there would be a directly correlated shorter hospital stay. However, studies conducted for a comparison between SCL and MLC have thus far provided conflicting results regarding mean hospital stay. With prospective studies by Gupta et al.[7] and Look et al.[21] reporting that despite a significantly decreased postoperative pain in the MLC group, there was no significant difference in mean times for hospital stay with a total study population of 40 and 64 respectively. However, Lai et al.[17] reported during a prospective study of 150 patients that MLC group not only had statistically significant decrease in postoperative pain but also had a significantly reduced mean hospital stay. Our study showed that patients in the MLC group were able to get an earlier discharge to return home compared with the SLC group who stayed for a longer period of time (P < 0.001).

The complications reported by Lai et al. included: Subcutaneous emphysema, intraperitoneal bile spillage, perforation of the gall bladder upon grasper application and slipped cystic artery duct clip. However, none of these reported complications were statistically significant.[17] Carvalho et al.[22] reported minor incidents including conversion of MLC to SLC in 2.8% of patients. These, along with minor rates of 1.9% minor umbilical site infections and 1% umbilical herniation, however, were not significant to recommend against MLC.

Another concern regarding the use of finer instruments for operative procedures is durability in the intraoperative setting. Novitsky et al.[18] reported that the major reason for suboptimal performance of MLC instruments was in the setting of inflamed and thickened gall bladder. MLC instruments were found to be more susceptible to damage and smaller diameter laparoscopes gave a lower quality resolution. These factors resulted in conversion from MLC to SLC in 24% of patients. However, it was concluded that due to similar operative times for both techniques and comparative postoperative morbidity this was not viewed as a major drawback against MLC. A meta-analysis of 18 studies done by Thakur et al.[23] reported that there was a decreased trend of SLC to conversion to open technique versus MLC, with a pooled odds ratio of 1.05 (0.52-2.12).

A study done by Chekan et al.[24] to compare cost burden clinical implications of different cholecystectomy procedures in the US hospitals found a minimal but statistically significant difference in total costs between MLC versus SLC. However, in comparing costs in a lower socioeconomic country such as Pakistan, we must take into account that most patients do not subscribe to health insurance plans. Our findings conclude that there is a markedly increased cost of MLC versus SLC $766 versus $529 with most of the cost difference being attributed to more expensive MLC instruments $147-244 versus SLC $49-98.

CONCLUSION

In conclusion, MLC is found to have similar surgical risks, postoperative pain and mobilization time compared to SLC. It is found that the MLC technique has a minimal learning curve, reflected by the fact that the first MLC intraoperative time took 61 min, however, by the end of the study, both groups had comparable intraoperative times. MLC, additionally, has favourable outcomes, allowing patients to request faster postoperative hospital discharge and earlier return to work. However, due to the significantly increased cost burdens associated with MLC and with no significant improvements in other variables including operative time, intraoperative blood loss and postoperative pain, this approach should not be routinely recommended to patients and cannot be recommended as the gold standard approach in a country of a lower socioeconomic status such as Pakistan.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.