Single incision laparoscopic cholecystectomy: Less scar, less pain.

Context and Aims: Our study aims to evaluate the post-operative pain and cosmesis of single-incision laparoscopic cholecystectomy (SILC) in comparison with the standard, 3-port laparoscopic cholecystectomy (SLC) with respect to the length of incision, cosmetic scores, post-operative pain scores and duration of hospital stay. SETTINGS AND
DESIGN: This comparative randomised study was conducted in a tertiary care centre teaching hospital between September 2012 and 2014. One hundred and fifty consecutive patients, who qualified as per inclusion criteria, were included in the study. SUBJECTS AND METHODS: Seventy-five patients were included in the SLC arm and 75 in the SILC arm. SILC procedure was carried out as transumbilical multiport technique and SLC as 3-port technique utilizing - 5, 5, 10 mm ports. STATISTICAL ANALYSIS USED: The data for the primary observations (post-operative pain scores, cosmetic score and incision length) and secondary observation (post-operative hospital stay) were noted. Weighted mean difference was used for calculation of quantitative variables, and odds ratios were used for pooling qualitative variables.
RESULTS: Pain scores at 4 and 24 h were significantly better for SILC arm than SLC arm (at 4 h - 4.84 ± 0.95 vs. 6.17 ± 0.98, P < 0.05 and at 24 h - 3.84 ± 0.96 vs. 5.17 ± 0.09, P < 0.05). Length of incision was significantly smaller (SILC - 2.631 ± 0.44 cm vs. SLC - 5.11 ± 0.44 cm), P < 0.05 and cosmetic score was significantly better in SILC arm (6.25 ± 1.24) than SLC arm (4.71 ± 1.04), P < 0.05. Difference between the hospital stay is insignificant for two arms SILC (2.12 ± 0.34) and SLC (2.13 ± 0.35), P > 0.05. DISCUSSION: Significant difference was found in duration and intensity of pain between two procedures at 4 and 24 h. Cosmesis was significantly better in SILC than SLC group, the sample size in our study was small to arrive at a definite conclusion. The procedure can be selectively and judiciously performed by surgeons trained in regular laparoscopic surgery. Furthermore, the threshold for conversion should be low in learning phase. Widespread application must await Level 1 evidence from prospective trials.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

There are a number of case series, studies and randomised control trials conducted for comparison of single-incision laparoscopic cholecystectomy (SILC) vis-à-vis standard laparoscopic cholecystectomy (SLC); however, the benefit of SILC is still debatable. Eight meta-analyses[12345678] have compared SILC- and SLC-related outcomes in the recent past. These studies confirmed the safety and feasibility of SILC. However, various other observations have not been consistently established. This makes it necessary to more closely compare SILC and SLC; in particular, to evaluate whether SILC is associated with less post-operative pain and better cosmetic results. In our study, we have made an attempt to evaluate the efficacy and effectiveness of single port laparoscopic cholecystectomy compared to the gold standard multiport laparoscopic cholecystectomy.

SUBJECTS AND METHODS

This comparative randomised study was conducted in a tertiary care centre teaching hospital, MLB. Medical College, Jhansi, between September 2012 and 2014. Random allocation of patients presenting with symptoms suggestive of gallbladder (GB) disease with confirmatory ultrasonography study was done to the two groups using the sealed envelope technique which was opened just before the skin incision. Both procedures were explained in detail along with merits and complications of each to the patients, and informed consent was taken from the patients for randomisation to study groups. One hundred and fifty consecutive patients who fit into the inclusion criteria were included in the study [Figure 1]. Seven-five patients were included in the SLC arm and 75 in the SILC arm

Figure 1

Trail design

Patients selection

The inclusion criteria

All patients between 10 and 85 years, with a diagnosis of chronic or acute cholecystitis, recurrent mild biliary pancreatitis, GB polyp (>3 cm), GB sludge, empyema and mucocele.

The exclusion criteria

Severe comorbid conditions (uncontrolled diabetes, hypertension, intrahepatic disease, severe direct hyperbilirubinaemia), American Society of Anesthesiologists Grade-4, choledocholithiasis and GB phlegmon (>7 days).

Operative technique

The technique of SLC was performed as a three port approach; SILC was performed using transumbilical multiport technique, as described earlier by Sinha and Yadav[9] and discussed in later sections.

Post-operative pain score was calculated by visual analogue scale[10] (1–10) at 4 and 24 h post-surgery. Patients were asked to rate the intensity of their pain on a scale of 1–10 with 1-being ‘no pain’ and 10-being ‘most agonising or unbearable pain.’ Cosmetic score was calculated by 10-point wound satisfaction score[11] (1-worst, 10-best). The length of incision for SLC was taken as the sum of all the three incisions.

RESULTS

Out of 75 patients operated by single port surgery, 18 were males and 57 were females [Table 1]. In the multiport group distribution was 19 males and 57 females. Majority patients were in 30–40 age group [Figure 2]. The mean age of patients in SILC group was 38.4 ± 8.53 years and in multiport group was 37.6 ± 10.34 years.

Table 1

Age and sex wise distribution of cases in the study groups

Figure 2

Graphic representation age sex wise distribution of cases in study groups

Length of incision is significantly smaller [Table 2 and Figure 3] and cosmetic score is significantly better [Table 3 and Figure 4] in SILC than SLC.

Table 2

Comparison of length of incision

Figure 3

Bar diagram showing comparison of length of incision between single incision laparoscopic cholecystectomy and standard laparoscopic cholecystectomy

Table 3

Comparison of cosmetic score between two groups based on wound satisfaction score (1 - worst, 10 - best)

Figure 4

Bar diagram showing comparison of cosmetic score between two groups based on wound satisfaction score (1 - worst, 10 - best)

A significant difference was found in the duration of post-operative pain score experienced in the two groups [Table 4 and Figure 5].

Table 4

Comparison of post-operative pain score in the study groups at 6 h after surgery and on post-operative day 1

Figure 5

Multiple bar diagram showing comparison of post-operative pain score in study groups at 4 h after surgery and on post-operative day 1

Difference in post-operative hospital stay noticed between 2 groups is not significant [Table 5].

Table 5

Comparison of hospital stay in study groups

No statistically significant rise in surgical complications occurred in the patients operated by SILC as compared to SLC. One of the patients who underwent SILC had liver injury, whereas one patient who underwent SLC had vessel injury (unidentified accessory cystic artery) and liver injury. Complications such as bile duct injury and due to pneumoperitoneum did not occur in either group.

DISCUSSION

Post-operative pain

Hao et al.[2] and Arezzo et al.[8] pointed out that SILC patients have less post-operative pain in the first 24 h, as opposed to the other six meta-analyses.[134567] In our study, we got significantly less post-operative pain scores for SILC arm than SLC arm [Table 6].

Table 6

Comparison of visual analogue scales of our study with the other studies

Cosmesis

Seven meta-analyses[12345678] showed that cosmetic score is better in SILC patients than SLC patients, whereas Sajid et al.[5] claimed no significant difference between the SILC and SLC. Our study conforms with the majority in concluding that length of incision is significantly lesser [Table 7], and cosmesis is significantly better for SILC than SLC [Table 8].

Table 7

Comparison of length of incision in our study with the other studies

Table 8

Cosmetic results of the studies included in the discussion

Hospital stay

Few studies reported of a benefit in hospital stay with SILC,[202425] we found no such benefit [Table 9].

Table 9

Comparison of recovery outcome (hospital stay) of our study with other studies

Distinguishing features of our technique

We have used single-incision multiport technique instead of specially designed single entry ports, which are costly, relatively more difficult to use as the differential movement between the ports is restricted in contrast to 3 separate ports which give better manoeuvrability. Umbilical incision [Figure 6] is made always inside the umbilical ring with flap raised as 1/3 supraumbilically and 2/3 infraumbilically.[9] Multiport used are one 10 mm, two 5 mm tube ports (Apple ports) as they prevent clashing of ports outside due to crowding as happens if all ports are flap valve type [Figure 7]. This limits the dissection and lowers the incidence of seroma formation. Routine laparoscopic instruments were used instead of curved and roticulating instrument which add to the cost and complexity of the procedure. Cautery attachment points are aligned along their long axis rather than at oblique angles to instruments, to prevent entangling of cautery wires and light and insufflation cord. Light cord and the insufflation tube were held by the second assistant at the right angles to the long axis of the instrument to prevent clashing. Preferred dissection is done in craniocaudal direction as greater dissection is possible because of lateral cramping at SILS site. Contrary to SLC, dissection is completed at GB fossa and GB is separated from all direction before dividing the clipped cystic duct which can now be removed from 10 mm port with 5 mm telescope at the right side port. This prevents repeated change of instruments.

Figure 6

Incision through umbilicus in single incision laparoscopic cholecystectomy

Figure 7

Position of instrument during single incision laparoscopic cholecystectomy with conventional laparoscopic instruments

CONCLUSION

In our study, the following conclusions were made - patients presenting to our institution with gallstone diseases belong to significantly younger group. Cosmesis is significantly better in SILC than SLC group. No significant difference was found in duration and intensity of pain between two procedures. Length of post-operative hospital stay for single port cholecystectomy is almost same as for multiport cholecystectomy. Mortality was nil in the present study.

The sample size in our study is small to make definite conclusion. However, it can be said that the procedure can be selectively and judiciously performed by surgeons trained in regular laparoscopic surgery, especially those doing SLC. Widespread application must await results obtained from Level 1 evidence from prospective trials.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.