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LAPAROSCOPIC CHOLECYSTECTOMY BY MINIMUM PORTS TECHNIQUE GIVES BETTER OUTCOME-AN OBSERVATION.

BACKGROUND

Laparoscopic cholecystectomy (LC) is the standard and universally accepted procedure compared to open cholecystectomy. The main advantages of laparoscopic surgery over open technique include better cosmetic outcome, reduced post-operative pain and rapid functional recovery. Innovative techniques like Natural Orifice Endoscopic Surgery (NOTES), Single-Incision Laparoscopic surgery (SILS) along with two-ports and three-ports laparoscopic surgeries have also been adopted to remove gallbladder as a procedure of choice in comparison to conventional four-ports surgery. Many surgeons prefer two ports to remove gallbladder when cosmesis and postoperative recovery are placed primarily. These newer techniques represent popularity in terms of the results as scarless, more pain-free, better cosmesis, early return of functional work and better quality of life for the patient.

Single port laparoscopic approach proposes to offer an acceptable cosmesis because it does not give scar due to port being hidden in the umbilicus. However, this type of technical procedure in minimal invasive surgery is more challenging because dissection is little cumbersome due to clashing of operative instruments, loss of normal ergonomic triangulation, restricted and limited vision and actual plane of dissection. Special wide port, angulated instruments and scopes are required for better and precious dissection. Hence SILS has been adopted with much caution though its popularity can't be ignored. All these factors might precipitate abrupt learning curve and enhances the risk of the development of hernia. Two-ports or four-ports laparoscopic cholecystectomy (LC) compared to SILS, surgery becomes easier to execute due to restoration of normal ergonomic triangulation, learning curve becomes shorter, causes minimal violation of anterior abdomen leading to minimum post-operative pain and acceptable cosmesis. With the recent techniques, the need for more high-tech instruments escalates the cost of surgery and causes limitation of the use of these minimally invasive techniques to few selected centres. Two-ports LC over the conventional techniques which requires minimal new instruments and can be performed at almost all laparoscopic centres without any extra cost and simultaneously achieve the goal of minimal invasive surgery in the modern era of laparoscopic surgery. The present study was carried out despite less number of available literatures in this field of laparoscopic surgery in comparison to conventional LC.

Aim of The Study

To determine the advantages of minimum port laparoscopic cholecystectomy over conventional cholecystectomy.

METHODS

This observational study was carried out over a period of 1 years at Gauhati Medical College from 1/1/17 till 4/1/18. All patients with cholelithiasis attended in the surgical OPD were evaluated. All symptomatic patients with BMI < 30 kg/[m.sup.2], ASA Grade I/II, Age > 20 yrs were included in the study. Patients with BMI > 30 kg/[m.sup.2], previous major abdominal surgeries, ASA Grade III/IV, refused to give consent, associated choledocholithiasis, evidence of pancreatitis and malignancy on clinical and USG examination were excluded from the study. The patients were selected by conveniences allocation technique. The sample size estimation was also done at conveniences.

The patients were evaluated by detailed history taking, a thorough clinical examination and investigations which includes a routine blood, Blood urea, serum creatinine, Liver function test (LFT), serum electrolytes, Na+/K+ and blood sugar. A USG was done in each patient to study status of gallbladder like calculi, wall thickness, common bile duct (CBD) status and features of acute inflammation or malignancy. An informed written and verbal consent explaining that he/she has understood the procedure and was obtained at least one day prior to surgery.

Patients were divided into two groups--

Group A--patients undergoing standard four-port LC

Group B--patients undergoing two-port LC.

Operative Procedure

After proper position and general anaesthesia (GA) pneumoperitoneum was created using C[O.sub.2] gas by placing a Veress needle followed by placement of a transumbilical/sub umbilical/supraumbilical 10-mm port with abdominal pressure maintained at 12 mm Hg. A 30 degree 10-mm laparoscope was passed, and the operative difficulty was assessed based on the degree of inflammation, adhesions, condition of gall bladder wall, presence of fistula formation with neighbouring organs/structures (Duodenum, CBD, colon, stomach, etc.)

Conventional Four-Port LC

The patient was placed in reverse Trendelenburg position and tilted to the left as convenient and surgery proceeded as standard and conventional procedure. A 10-mm trocar was placed in the epigastrium to the right of the falciform ligament with two additional 5-mm ports in the right upper abdomen two finger breadths below the costal margin in mid clavicular line and anterior/midaxillary line at the level or just below the umbilicus. Dissection of the gall bladder was performed by the standard technique by first grasping and lifting the fundus, followed by dissection of the cystic duct and artery. Once the 'critical view' of these structures was obtained, these were clipped and divided. The gall bladder was removed from its bed using electrocautery and retrieved through the epigastric port.

Two-Port LC

Following the placement of umbilical port, instead of a 10mm, a 5-mm epigastric port was place. Two special 2.3 mm alligator graspers [Fig. 1] were used trans abdominally for grasping the fundus [Fig. 2] and Hartmann's pouch of the gallbladder for its retraction and manipulation [Fig. 3], respectively. A 1-0 silk suture was also used to retract fundus in different time. In some cases, fundus can be retracted by a No 1 or No 1- Silk suture instead of alligator. Sometime more than 1 suture may be required to hold different places of GB to make safety triangle. Using the standard Maryland laparoscopic instrument, the cystic duct and artery were dissected as in the four-port technique [Fig. 4]. For clipping the cystic duct and artery, a 5-mm clip applicator was used with 300-mm clips. In case of wider cystic duct, single-hand suturing of the duct was done with 2/0 silk or 400 sized LIGACLIP applied. Alternatively, the position and size of the scope was changed to a 5-mm 30[degrees] scope through the epigastric port and clips (300/400 mm) were applied through the 10-mm umbilical port. The structures were divided, and dissection proceeded by reversing the laparoscope and dissecting instruments to their original sites. Gallbladder specimen was retrieved through the umbilical port by rail-road technique or using 5-mm 30[degrees] scope through the epigastric port and 10-mm jaw forceps from the umbilical port. The ports were closed in layers. Sheath with 2/0 vicryl and skin with 3/0 nylon in both procedures. In some occasion 5 mm port skin by simple skin stapler without closing sheath. Skin stapler eventually used to close the wounds in many instances.

If in any patient, for any reason, there was difficulty in proceeding with two ports, additional port(s) was used, or the procedure was converted to open cholecystectomy. The patients were followed up for 30 days after discharge.

Comparing the Two Type of Operative Techniques on

a. Time period of operation: Counted from "skin to skin.

b. Conversion from two-port LC to four-port LC/open cholecystectomy.

c. Complications: CBD injury, hepatic injury/bleed, biliary/stone spillage, bowel injury, vascular injury or any other complication up to 30 days post-operatively.

d. Post-operative pain: Site and severity of pain at 2, 4, 6, 8, 12 and 24 hours; and total 24 hours.

e. Analgesia required.

f. Post-operative hospital stay.

g. Cosmesis: Assessed at the end of 30 days by the patient and independent nurse in the ward/OPD. Every patient was asked to rate cosmesis on a scale of 1 (Worst) to 10 (Best). The mean of both the patients score and nurse's score was taken as the final score [Fig. 5]

Statistical Analysis

Parametric summary statistics were presented as means with standard deviation. Non-parametric statistics were presented as medians with interquartile ranges. Categorical data were analysed with Chi-square test. Independent t-test was used to test the means using the SPSS software package version 19.0 (SPSS Inc., Chicago, II, USA).

RESULTS

In this descriptive study a total 76 patients were operated during the study period. 10 patients were excluded as they underwent additional procedure. Six patients out of 10 had an American Society of Anaesthesiologists (ASA) grade more than II and were not included in the study as per the study protocols. A total of 60 patients were included in the study. 30 patients were randomised each into the four-port and two-port. Out of three patients, two in the four-port group and one in the two-port group were lost to follow-up. A total of 57 patients were left in the study group for the final analysis and follow up [Chart 1- CONSORT Flow Chart]. The mean age, sex ratio, ASA grades and BMI between the two groups were comparable [Table 1].

The operative time between the two groups were not statistically significant (Four Port LC-67 min; Two port mini LC-71 min) [Table 2]. The operative difficulty score showed that both groups were comparable in terms of difficulty of operation levels [Table 2]. The Average incidence of per-operative complications such as bleeding from liver bed (Four port LC-1 [3.33%], Two port mini LC-2 [6.66%] and bile spillage (Four port LC-3 [10.0%], Two port LC-2 [6.66%]) were not significantly different between both groups; however, there was a single incidence of minor CBD injury in the two-port group, which was detected peroperatively and repaired [Table 3]. One patient from two port LC group required open cholecystectomy (0.18%), and one patient needed.

Enrolment--(Chart 1. Consort Flow Chart)

a. Assessed for eligibility (n=70)

b. Randomized (n=60) [??] Excluded (n=10). Not meeting inclusion criteria. Other procedure coupled s (n=6). ASA grade more than II.

c. Allocated to 4 port (n=30). Allocated to 2 port LC (n=30).

d. Lost to follow up (n=2) in 4 port.

e. Lost to follow up (n=1) in 2 port.

f. Analysed (n=28) in 4 port.

g. Analysed (n=29) in 2 port.

h. Total analysed = 57 [Consort Flow Chart type].

Conversion to four port LC (3.33%). The conversion to open cholecystectomy was required for an abnormal vessel injury, while the conversions to four port LC were due to difficult anatomy and adhesions around the GB fossa. That patient was converted to open cholecystectomy for dense adhesions around the gallbladder and obliterated narrow Calot triangle. There was oedema and fixed infundibulum at Rouviere's level.

The average post-operative pain scores (As assessed by VAS) of both groups as shown in table-4. The average pain scores as assessed during post-operative period at 2, 4, 6,8,12 and 24 hours was significantly less in two port LC than in four port LC. But after 24 hours no difference of pain in both groups. The parenteral analgesic requirement (i.m Diclofenac 75 mg) in the two-port mini LC was significantly lower than four port LC for the first 24 hrs. The mean duration of hospital stay was similar in both groups; four port LC-25 hrs, two port LC-24 hrs.

The patients' return to daily activities at home was faster by almost one day and was statistically significant (Four port LC-4 days, two port LC-5 days).

The standard cosmesis scoring system on a scale of 1-10 (means of both patients and the independent nurse' score) was significantly better in the two port LC compared to four port LC at the end of 30 days.

DISCUSSION

Considering the history of cholecystectomy from Langenbeck's first open cholecystectomy with a hospital stay of a week into a day-care specialty following the introduction of LC is indeed magnificent in the era of surgical evolution. [1] The main focus has been on the-

Reduction of pain and improvement cosmesis throughout the history of cholecystectomy. In fact, post-operative pain is the key factor for the delay in discharge in day-care cholecystectomies. The concept of scarless or less scar has led to increased acceptance of the procedures among patients. Surgeries by less port may seem more costly procedures but by achieving higher bed-patient ratio, reduced requirement of analgesia and with one less assistant they may indeed be cost-effective on a long-term basis. Particularly in private sector. Two-port LC using conventional instruments can afford the benefits of reduced port surgeries without cost escalation.

Most significant advantage of two-port LC as described in the present study is the ease of performing the technique, and main principles of surgery remain similar to the conventional four-port LC. Compared to this, other LC like NOTES [2] and SILS [3,4] are technically more demanding as because the dissection becomes more difficult due to clashing of instruments, loss of normal triangulation, restricted vision and depth of dissection. Special large port, angulated instruments and scopes are needed for better dissection. All these.

Factors lead to a steeper learning curve, and hence, operating time. [4] The port sizes in our study were 10 + 5 + 2.3. Various port sizes have been used by other researchers, which might require more sophisticated instruments [Table 5]. There is not standard size of the ports, and we choose the above size simply to use the normal four port LC instruments.

In the present study, the use of two ports and graspers we used did not increase the operative difficulty as the mean duration of the procedures was similar in both groups though operative time varies with different studies as some require less and some more than the conventional technique. [5-9]

The operative difficulty based on the status of gallbladder, adhesions around the gallbladder fossa and elsewhere in the abdomen, Calot\s triangle and cystic duct anatomy was similar in both groups in our study. The incidence of intraoperative and post-operative complications was similar in comparison to other studies; however, it is not reported by any other study. The present study had a single incident of minor CBD injury in the two-port mini LC. It would be difficult to attribute the same to the use of two ports, as it was the only case which happened in the entire study group. Besides this, no other major intra-operative complication was noted in the entire study group. The conversion rates from two port mini LC to four port LC and open cholecystectomy in many studies are in the range of 23% to 38%. [8,10,11] The conversion rates from two port mini LC in our study were much less than the other studies. The main reasons in our study for conversions were difficult anatomy due to dense inflammation from cholecystitis and one abnormal vascular injury. Instrument failure was seen in few early studies, and we had no episode of instrument failure. A planned two-port surgery must be given up in the event of such difficult anatomy on initial diagnostic exploration or hindrance to proceed further during the course of the dissection. [12,13] A conversion can be with additional ports or with open cholecystectomy.

Researchers such as Cheah et al, and Bisgaard et al attributed less pain following two port LC. [6,14] By omitting two 5-mm ports resulted in decreased post-operative pain in the first 24 hours. This has been observed by many other studies, which have also shown reduced pain in reduced port surgery compared to conventional four-port LC. The postoperative pain was assessed by VAS, which is the same method used in other studies. The pain was recorded during the patient's stay at hospital. The post-operative pain in our series was significantly lower in the first 24 hrs only, and not later. 24 hrs (Group A 89.5%, Group B 92.7%). This was further support by less requirement of analgesia and the early return to their activities in the two port mini LC in contrast to the four port LC.

The mean length of hospital stay was same in both groups. This was in consistent with other studies. [6,7,10,11,14-17] [Table 5]. Even though we did not perform these procedures as outpatient procedures but in our view, these can be performed as day-care procedures.

Cosmesis has been one of the reasons for easy acceptance of laparoscopic surgery among the patient population. Smaller and lesser incisions have led to minimal scarring and improved cosmesis. [12,18] With 0 being worst and 10 being the best. In our study, we had a nurse blinded to procedures and the patient's own score which minimised bias, the final score was arrived at by calculating the mean of the two scores. In our study, the cosmetic score was significantly better in two port LC, which is consistent to other studies where cosmetic benefit was studied.

CONCLUSIONS

In our conclusion, LC can be performed with two-port technique using 10-mm umbilical, 5-mm epigastric and two 2.3-mm alligator graspers in properly selected cases and optimise the benefits of minimal access surgeries. A No. 1-0 or No. 1 silk suture can be used instead of grasper as per surgeon's convenience. Single incision LC (SILS) can be done with much better cosmesis but is a cumbersome operation. Less the port, much the cosmesis is the dictum in the genesis of laparoscopic surgery.

REFERENCES

[1] NIH Consensus Conference. Gallstones and laparoscopic cholecystectomy. JAMA 1993; 269(8): 1018-24.

[2] De, Demaria EJ, Reynolds JD, et al. New developments in surgery: Natural Orifice Transluminal Endoscopic Surgery (NOTES). Arch Surg 2007;142(3):295-7.

[3] Curcillo PG 2nd, Wu AS, Podolsky ER, et al. SPATM cholecystectomy: a multi-institutional report of the first 297 cases. Surg Endosc 2010;24(8):1854-60.

[4] Navarra G, Pozza E, Occhionorelli S, et al. One-wound laparoscopic cholecystectomy. Br J Surg 1997; 84(5):695.

[5] Ramachandran CS, Arora V. Two-port laparoscopic cholecystectomy: an innovative new method for gallbladder removal. J Laparoendos Adv Surg Tech A 1998;8(5):303-8.

[6] Bisgaard T, Klarskov B, Trap R, et al. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trail. Sug Endosc 2002;16(3):458-64.

[7] Schwenk W, Neudecker J, Mall J, et al. Prospective randomized blinded trial of pulomonary function, pain and cosmetic results after laparoscopic vs. microlaparoscopic cholecystectomy. Surg Endosc 2000;14(4):345-8.

[8] Look M, Chew SP, Tan YC, et al. Post-operative pain in needlescopic versus conventional laparoscopic cholecystectomy: a prospective randomised trial. J R Coll Surg Edinb 2001;46(3):138-42.

[9] Lomanto D, De Angelis L, Ceci V, et al. Two-trocar laparoscopic cholecystectomy: a reproducible technique. Surg Laparosc Endosc Percutan Tech 2001;11(4):248-51.

[10] Alponat A, Cubukcu A, Gonullu N, et al. Is minisite cholecystectomy less traumatic? Prospective randomized study comparing minisite and conventional laparoscopic cholecystectomies. W J Surg 2002;26(12):1437-40.

[11] Sarli L, Iusco D, Gobbi S, et al. Randomized clinical trial of laparoscopic cholecystectomy performed with mini-instruments. Br J Surg 2003;90(11):1345-8.

[12] Novitsky YW, Kercher KW, Czerniach DR, et al. Advantages of mini-laparoscopic vs conventional laparoscopic cholecystectomy. Arch Surg 2005;140(12):1178-83.

[13] Lai EC, Fok M, Chan AS. Needloscopic cholecystectomy: prospective study of 150 patients. Hong Kong Med J 2003;9(4):238-42.

[14] Cheah WK, Lenzi JE, So JB, et al. Randomized trial of needlescopic versus laparoscopic cholecystectomy. Br J Surg 2001;88(1):45-7.

[15] Schmidt J, Sparenberg C, Fraunhofer S, et al. Sympathetic nervous system activity during laparoscopic and needlescopic cholecystectomy. Surg Endosc 2002;16(3):476-80.

[16] Ainslie WG, Catton JA, Davides D, et al. Micropuncture choleystectomy vs conventional laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc 2003;17(5):766-72.

[17] Huang MT, Wang W, Wei PL, et al. Minilaparoscopic and laparoscopic cholecystectomy: a comparative study. Arch Surg 2003;138(9):1017-23.

[18] Yuan RH, Lee WJ, Yu SC. Mini-laparoscopic cholecystectomy: a cosmetically better, almost scarless procedure. J Laparoendosc Adv Surg Tech A 1997;7(4):205-11.

Purujit Choudhury (1), Abhijit Sarma (2)

(1) Associate Professor, Department of Surgery, Gauhati Medical College, Guwahati, Assam, India.

(2) Associate Professor, Department of Surgery, Gauhati Medical College, Guwahati, Assam, India.

'Financial or Other Competing Interest': None.

Submission 22-03-2019, Peer Review 01-05-2019, Acceptance 07-05-2019, Published 20-05-2019.

Corresponding Author:

Dr. Abhijit Sarma, Associate Professor, Department of Surgery, Gauhati Medical College, Guwahati, Assam, India.

E-mail: drpurujit@yahoo.in

DOI: 10.14260/jemds/2019/361

Caption: Figure 1. All Ports Displayed with Alligators

Caption: Figure 2. Alligators with Operating Team at GMC

Caption: Figure 3. Alligators Displayed. 1 -0 Silk used to Retract Fundus

Caption: Figure 4. Alligator

Caption: Figure 5. Fundus Retracted

Caption: Figure 6. At Neck

Caption: Figure 7. Grasper at The Neck

Caption: Figure 8. CD Dissected

Caption: Figure 9. CD Dissected and Divided

Caption: Figure 10. Cosmetic Scar After 2 Ports. Black Arrow= 10 mm; White Arrow=5 mm.
Table 1. Patient Demography

                        4 Port Group    2 Port Group    p Value
                           (N-30)          (N-30)

Mean age (yrs.)             40.8            37.0          .12
M:F ratio              1:3.4-6(M) and   1:3.1-7(M)and     .23
                           22(F)            22(F)
ASA grade (I-II)           40.8             51.4          .14
BMI (Mean)                 22.1             21.9          .15

Table 2. A Comparison

                                Four Port   Two Port   P value
                                  Group      Group

Duration of surgery                67          71       .727
(Minutes)
Operative difficulty score          6          5        .303
Analgesic needed                   2.9        2.3       .003
Length of stay (hrs)               25          24        .76
Return to daily activities          5          4        .001
(days)
Cosmesis                            5          7        .001
Post-operative                      1         1.5        .24
complications

Table 3. Intra-Operative Complications

                                Four Port        Two Port
Complications                     Group            Group

Bleeding from cystic artery         0                0
Bleeding from hepatic artery        0                0
Bleeding from liver bed             1                2
Bleeding from portal vein           0                0
Bleeding from other sources         0                0
CBD injury                          0            1 (minor)
Injury to gastrointestinal
tract
Stone spillage                      3                2
Any other complications             0                0
                                             1 to open due to
                                            injury to abnormal
Converted                          Nil      vessel. 1 converted
                                                 to 4 port
                                                technique.

Table 4. Pain Score

                                      Confidence Limit
VAS at    Group   Average   p Value         (95%)
hrs.
                                       Lower    Upper

2           A       7.3      .006      .213     1.213
            B       6.6
4           A       6.4        0       .392     1.319
            B       5.5
6           A       5.7        0       .432     1.380
            B       4.8
8           A        5         0       .679     1.611
            B        4
12          A       3.9        0       .393     1.337
            B        3
24          A        2       .039      .023     .871
            B       1.6
48          A        1       .749      .370     .267
            B       1.2
72          A        1       .743      .200     .143
            B       1.1

Table 5. Comparison of Various Variables in Two Port Technique
Journal of Minimal Access surgery (Oct-Dec-2014); Vol 10, Issue 4.

                 N-CLC   N-RPG   Port   Operating   Pain Difference
                                          Time

Schwenk et al     25      25     5-3      Equal     Not difference
Cheah et al       25      37     10-3     Equal        Decreased
Look et al        38      28     10-3      NA          Decreased
Alponat et al     36      22     10-3     Equal     Not difference
Bisgaard et al    27      25     5-3       NA          Decreased
Sarli et al       68      67     12-3     Equal        Decreased
Ainsli et al      68      21     10-3     Equal     Not difference
Huang et al       19      25     5-3    increased      Decreased
Novitsky et al    33      34     10-5     Equal        Decreased

                   Cosmesis      Conversion
                  Difference     to CLC (%)

Schwenk et al      Superior          1
Cheah et al           NA             5
Look et al            NA             7
Alponat et al      Superior          5
Bisgaard et al     Superior          4
Sarli et al        Superior          7
Ainsli et al          NA             3
Huang et al      No difference       5
Novitsky et al     Superior          8

                         Additional
                           Comment

Schwenk et al    No difference in pulmonary
                          function
Cheah et al        Similar oral analgesic
                         requirement
Look et al       Similar functional recovery
Alponat et al      Randomization after lap
                         examination
Bisgaard et al        M-LC is feasible
Sarli et al       Enhances advantage of LC
Ainsli et al          Reduces analgesic
Huang et al           M-LC not accepted
                         universally
Novitsky et al   Instrument durability need
                       to be increased
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Title Annotation:Original Research Article
Author:Choudhury, Purujit; Sarma, Abhijit
Publication:Journal of Evolution of Medical and Dental Sciences
Date:May 20, 2019
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