ORIGINAL�ARTICLE ABSTRACT Objective: To compare the day case Laparoscopic cholecystectomy with conventional Laparoscopic cholecystectomy in terms of early return to activities and intensity of postoperative pain. Study Design: Randomized control trial (Parallel). Place and Duration of Study: Department of Surgery Pakistan Institute of Medical Sciences/ Shaheed Zulfiqar st th Ali Bhutto Medical University Islamabad. Study was conducted from 1 Nov 2014 to 30 April 2015. Materials and Methods: After approval of hospital ethical committee, patients who were fulfilling the inclusion criteria were included in study after taking informed and written consent. Sample size was calculated using WHO sample size calculator, which turned out to be 42 for each group. Patients were divided into two groups, group A and group B by lottery method. Patients in group A had undergone Day case Laparoscopic cholecystectomy and patients in group B had undergone Conventional Laparoscopic cholecystectomy. Data was collected and recorded on purposively designed Performa. Data was analyzed using SPSS 17; paired t test was used to calculate p-value. Results: In group A, among 42 patients 13(31%) were on VAS 4, 13(31%), on VAS 5, 8(19%), in VAS 3, 6(14.3%), in VAS 2 and 2(4.8%), in VAS 6. The minimum and maximum “number of days to return to activities” was 3 and 7 days respectively. Among 42 patients, 20(47.6%) patients had returned to their home activities in 3 days, 13(31%) in 4 days, 5(11.9%) in 5 days, 2(4.8%) in 6 days and 2(4.8%) in 7 days. In group B the minimum and maximum intensity of pain on Visual Analogue Scale was 2 and 6 respectively. Among 42 patients 15(35.7%) were on VAS 5, 14(33.3%) were on VAS 3, 8(19%), in VAS 4, 4(9.5%), in VAS 6 and 1(2.4%), in VAS 2. The minimum and maximum “number of days to return to activities” was 6 and 10 days respectively. Out of 42 patients 17(40.5%) had returned to their home activities in 9 days, 17(40.5%) in 8 days, 4(9.5%) in 7 days, 3(7.1%) in 10 days and 1(2.4%) in 6 days. Conclusion: Patients undergoing day case LC do return to their routine activities earlier than those who undergo conventional LC, but there is no difference in terms of intensity of post-operative pain as measured on Visual analogue scale. Key Words: Cholelithiasis, Day Case Surgery, Laparoscopic, Day Case Laparoscopic Cholecystectomy, Laparoscopic Cholecystectomy. Der Weil was the first surgeon who found gall stone during surgery while operating upon a patient with 1 peritonitis in 1687. Ever since the operative management of gall stones is in process of co ntin u o u s evo lu tio n . It was Carl Jo h an n Langenbuch, who performed the first ever open 2 c h o l e c yste c to my i n G e r m a ny. L ate r o p e n cholecystectomy became the gold standard treatment for the management of symptomatic gall 3 stone disease. Surgeons around the globe were trying to make the procedure as less invasive as possible. The technique of SILS was introduced in which a single umbilical incision was used to insert three small ports. Recently NOTES (Natural Orifices Transluminal Endo 4 Surgery) has been introduced , in which natural Introduction Cholecystectomy is the commonest surgical 1 intervention in hepatobilliary system. Stal Pert Von Comparison of Day Case Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy 1 2 3 4 Muhammad Asad , Aatif Inam , Muhammad Burhan Ul Haq , Zafar Iqbal Malik Correspondence: Dr. Muhamnmad Asad Senior Registrar Department of General Surgery Islamic International Medical College Riphah International University, Islamabad E-mail: tfortipu@gmail.com 1 Department of General Surgery Islamic International Medical College Riphah International University, Islamabad 2,3,4 Department of General Surgery Pakistan Institute of Medical Sciences, Islamabad Funding Source: NIL; Conflict of Interest: NIL Received: May 16, 2019; Revised: August 13, 2019 Accepted: August 15, 2019 Day Case Vs Conventional Laparoscopic CholecystectomyJIIMC 2019 Vol. 14, No.3 131 orifices are used to gain access to the cavity. First NOTES was performed on a 43 years female with 5 symptomatic gall stones in 2007. Evolution in surgery has led to the concept of day case surgery, which means patient is discharged on same day after surgery. Day surgery is also called 6 outpatient surgery or ambulatory surgery. Invention of laparoscopic surgery has made it possible to do number of procedure on day case basis, because of the small incision and less pain postoperatively. Now a day's number of conventional procedures like laparoscopic hernia repair and laparoscopic cholecystectomy are being performed on day case basis worldwide. With the passage of time acceptability of day case surgery has increased among clinicians, patients, families and also 7 insurance agencies. Shortage of medical services in most part of world and financial problems has made space for day case surgery, because of lowering the 8 treatment cost to less than 50%. Study in Pakistan showed reduction in treatment cost of PKR 6200 to 22800 in day case laparoscopic cholecystectomy 9 (LC). That is why day case surgery has gained worldwide acceptance. Day case laparoscopic cholecystectomy is being 5 extensively performed in developed countries , but its scope in developing countries is still less. Laparoscopic cholecystectomy has progressively shortened the hospital stay from 2 to 4 days to 6-8 9,10 hours. Studies have also shown early return to 11 home activities in Day Case LC was 22 days. Safety profile and technique of LC is making it an “ideal” for 12,13 day case surgery. Recent literature review has shown Laparoscopic cholecystectomy as safe as 10 conventional laparoscopic cholecystectomy. Up to 70% of patients with symptomatic disease are ideal 14 for day case LC. While there is reasonable volume of data is available from developed world on safety and feasibility of day case LC, Pakistan is lacking behind on this subject and more and more research work is required to establish the safety and feasibility of this procedure in our country. In developing countries like Pakistan Day case LC is still in eggshell. One of the most important reasons for this is inadequate published data on safety and feasibility of procedure. It is the need of hour to collect and publish data on safety and feasibility of day case surgery in our part of world. Surgeons are very reluctant to offer day case LC to their patients in our part of world. Quality local research data will give surgeons confidence in decision making for day case laparoscopic cholecystectomy. A study was planned to compare the day case LC with conventional LC in terms of mean of number of days of early return to activities and means of intensity of postoperative pain on VAS. Materials and Methods Study design was Randomized Controlled Trial (Parallel) with allocation ration of 1:1. Study was conducted at department of General Surgery, PIMS, Shaheed Zulfiqar Ali Bhutto Medical University st th (SZABMU) Islamabad from 1 Nov 2014 to 30 April 2015. Sample size was calculated using WHO sample size calculator. Taking 18(2-52) days as population mean+/-SD and 14(2-32) days as test value of population mean+/- SD for early return to activities 15 from previous literature. Level of significance was taken 5%. From given values 42 sample size was calculated for each group. Consecutive sampling was done as per inclusion and exclusion criteria. Operating surgeons were blinded and sampling was done by on floor post graduate trainee. Permission was taken from hospital ethical review board after detailed discussion and defense before the ethical committee. Inclusion criteria was to include all patients with un- complicated Cholelithiasis undergoing Laparoscopic cholecystectomy in study from 14 years to 60 years of age, both female and male patients and patients in ASA grade 1 and 2. Patients with known co m p l i cat i o n s o f C h o l e l i t h i a s i s l i ke a c u te cholecystitis and acute pancreatitis, patients with known IHD, uncontrolled DM and uncontrolled HTN, any bleeding disorder and patients who are unfit for GA, or in ASA grade 3 and 4 were excluded from study. Day case LC was defined as discharge from hospital within 12 hours of admission while conventional LC was defined as discharge from hospital after 24 hours of admission. Return to home activities was calculated in days, from the time of admission to the time of return to routine home activities. Patient was allowed to return to home activities if he was not having any surgical complications, able to move independently for eating, drinking and toilet, has no drain placed, was pain free and tolerating oral diet. JIIMC 2019 Vol. 14, No.3 132 Day Case Vs Conventional Laparoscopic Cholecystectomy Intensity Postoperative pain was assessed after 6 hours using Visual Analogue scale (VAS). Study population was all patients, who were booked for Laparoscopic cholecystectomy during the period of study at Surgical Unit 3 of PIMS, SZABMU. Patients who were fulfilling the inclusion criteria were included in study after taking informed and written consent. Patients were divided into two groups, group A and group B by lottery method. Randomization was done by assigned on floor post graduate trainee. Operating surgeons were blinded about group allocation of participants. Patients in group A had undergone Day case laparoscopic cholecystectomy and patients in group B had u n d e r g o n e C o n v e n t i o n a l L a p a r o s c o p i c cholecystectomy. Pain was measured by VAS (Visual analogue score) at 6 hours postoperatively and number of days to return to home activities was asked to patient on follow up. For follow up contact numbers and addresses were recorded. Data was collected and recorded on purposively designed Performa. SPSS 17 was used for data entry and analysis. Mean and standard deviation was calculated for numerical data (parametric) like age, number of days of return to activities and intensity of postoperative pain and frequencies were calculated for categorical data like sex. Unpaired T test was used for numerical data like mean of no of days to return to home activities and mean of postoperative pain. P value <0.05 was considered significant. Results Total of 84 patients were included in study. In Group A there were 42 patients who underwent Day Case Laparoscopic Cholecystectomy and in Group B there were 42 patients who underwent conventional Laparoscopic Cholecystectomy. In group A, total number of female patients was 32(76.2%) and male were 10(23.8%). Mean age was 38.95 years with SD of ±9.798. All the patients in group A underwent successful laparoscopic cholecystectomy without any major complications. Out of 42 patients 40(95%) were discharged successfully on same day of admission, fulfilling the Day case Laparoscopic Cholecystectomy Criteria. Rest of the two patients was discharged on second day of surgery. The reason for failure to discharge on same day of surgery was pain and nausea in both patients. The minimum and maximum intensity of pain on Visual Analogue Scale was 2 and 6 respectively with mean of 3.93 and SD of ±1.135. Among 42 patients 13(31%) were on VAS 4, 13(31%) were on VAS 5, 8(19%) were in VAS 3, 6(14.3%) were in VAS 2 and 2(4.8%) were in VAS 6. The minimum and maximum “number of days to return to activities” was 3 and 7 days respectively, with mean of 3.88 and SD of ±1.109. Out of 42 patients 20(47.6%) had returned to their home activities in 3 days, 13(31%) in 4 days, 5(11.9%) in 5 days, 2(4.8%) in 6 days and 2(4.8%) in 7 days. In group B, total number of female patients was 32(76.2%) and male were 10(23.8%). Mean age was 44.83 years with SD of ±14.553. All the patients in group B underwent successful laparoscopic cholecystectomy without any major complication. All patients were discharged successfully on second day of admission. The minimum and maximum intensity of pain on Visual Analogue Scale was 2 and 6 respectively with mean of 4.17 and SD of ±1.080. Among 42 patients 15(35.7%) were on VAS 5, 14(33.3%) were on VAS 3, 8(19%) were in VAS 4, 4(9.5%) were in VAS 6 and 1(2.4%) were in VAS 2. The minimum and maximum “number of days to return to activities” was 6 and 10 days respectively, with mean of 8.4 and SD of ±0.857. Out of 42 patients 17(40.5%) had returned to their home activities in 9 days, 17(40.5%) in 8 days, 4(9.5%) in 7 days, 3(7.1%) in 10 days and 1(2.4%) in 6 days. There was no statistically significant difference between the two groups in terms of intensity of pain on VAS, as P value was greater than 0.05 (P-value: Table I: No of Days to Return to Ac�vi�es Table II: Intensity of Post-Opera�ve Pain in Both Groups on VAS JIIMC 2019 Vol. 14, No.3 133 Day Case Vs Conventional Laparoscopic Cholecystectomy 0.359 using paired t-test), while there was statistically significance difference in two groups in terms of no of days to return to routine activity as p value was less than 0.05 (P-value: 0.000 using paired t-test) Discussion Our study has demonstrated success rate of 92.5%, which is fairly consistent with the international reported figures, which is 95% as reported by Hamad 16 et al. Success rate is quite lower if proper patient selection is not done. Careful patient selection base on the inclusion and exclusion criteria should significantly reduce the number of failed day case surgeries, as patient unfit for day case surgery was identified as leading cause of day case surgery failure 17 in literature. In Our study, which has demonstrated success rate almost comparable to international literature, careful patient selection was done using preset inclusion and exclusion criteria. In our study we studied the two factors, one is postoperative pain and other one is the early return to home activities. Postoperative pain is one of the most important reasons for failure to discharge patient on same day of surgery. Literature has reported that postoperative pain and nausea is the reason for failure to discharge and even readmission 18 majority of patients undergoing day case surgery. As in our study, minimal post-operative pain has been included in criteria for discharge along with other parameters in almost all of the reported 19 literature on day case surgery. In our study failure to discharge rate after day case surgery was 5%. In all 5% of patients, reasons for delayed discharge was nausea and vomiting, which is again consistent with 18 reported literature. In our study Visual analogue scale (VAS) was used to assess the intensity of post- operative pain. VAS is easy to record and easy to understand scale, which is being used by most of the 20 researcher around the globe. Requirement for analgesics in both groups could have been a good variable to record, which our study lacks. Our study also did not find any significant difference between the two groups in term of postoperative pain intensity as P value was more than 0.05, which translates into the fact that patients who are being discharged home on same day will not need extra care for pain management as compared to other group. Early return to routine activities is quite an important factor in comparing the two groups. The more the patient stays in hospital; the delayed will be his return to normal life. Our study has found significant difference between the two groups in term of early return to routine activities as the P value is less than 0.05. Average of 10 days have been reported in literature for no of days to return to routine activities 21 after conventional laparoscopic cholecystectomy. Our study has demonstrated 9 mean days for return to routine activities after conventional LC, while 3.88 mean days for day case LC, which was found to be statistically significant. This single variable shows that number of sick leaves days can be reduced by adopting day case surgery, where feasible, but more studies are warranted to validate and strengthen this claim. As it is evident from the above literature and from our study, that the LC can be performed with success and with safety on day case basis; as shorter hospital stay did not affect the outcomes and rate of complications after surgery. On the other hand day case surgeries have shortens the waiting list for surgeries and have reduced the total cost of surgery 22 because of shorter hospital stay. Certain principles should be met for the success of day case surgery. Careful selection of patients after setting inclusion and exclusion criteria and vigilant management of postoperative pain are the parameters for the success of day case surgery. Conclusion Patients undergoing day case LC do return to their routine activities earlier than those who undergo conventional LC, but there is no difference in terms of intensity of post-operative pain as measured on Visual analogue scale. REFERENCES 1. Chalkoo M, Ahanger S. The Historical Perspective, Current Advancements and Innovations in Laparoscopic Cholecystectomy. J Pioneer Med Sci. 2012; 2(3):86–7. 2. Beal JM. Historical perspective of gallstone disease. Surg Gynecol Obstet. 1984; 158(3):181–9. 3. Shaikh H, Abbas A, Aleem S, Lakhani M. Is mini-laparoscopic cholecystectomy any better than the gold standard? A comparative study. J Minim Access Surg. 2016; 13(1):42. 4. Khashab MA, Kalloo AN. Natural orifice translumenal endoscopic surgery. Curr Opin Gastroenterol. 2010; 26(5):471–7. JIIMC 2019 Vol. 14, No.3 134 Day Case Vs Conventional Laparoscopic Cholecystectomy 5. Malik A, Mellinger J, Hazey J, Dunkin B, MacFadyen BJ. Endoluminal and transluminal surgery: Current status and future possibilities. Surg Endosc. 2006; 20(8):1179–92. 6. Jiang H, Han J, Lu A, Liu X. Day surgery management model in China: Practical experience and initial evaluation. Int J Clin Exp Med. 2014; 7(11):4471–4. 7. An Y, Wang Z. Concept and basic problems of day surgery. Chinese J Pract Surg. 2007; 27:38–40. 8. Zhang Z, Yu T, Li H. Study on medical expenses and bed usage under day surgery model. Hebei Med J. 2007; 13:398–402. 9. Chawla T, Ali A, Jamal A. Ambulatory laparoscopic cholecystectomy: Is it safe and cost effective? J Minim Access Surg. 2009; 5(1):8. 10. Briggs CD, Irving GB, Mann CD, Cresswell A, Englert L, Peterson M, et al. Introduction of a day-case laparoscopic cholecystectomy service in the UK: A critical analysis of factors influencing same-day discharge and contact with primary care providers. Ann R Coll Surg Engl. 2009; 91(7):583–90. 11. Tamhankar AP, Mazari F, Olubaniyi J, Everitt N, Ravi K. Postoperative Symptoms, After-Care, and Return to Routine Activity After Laparoscopic Cholecystectomy. JSLS J Soc Laparoendosc Surg. 2011; 14(4):484–9. 12. Ahn Y, Woods J, Connor S. A systematic review of interventions to facilitate ambulatory laparoscopic cholecystectomy. Hpb. 2011; 13(10):677–86. 13. Mehraj A, Naqvi MA, Feroz SH, ur Rasheed H. Laparoscopic cholecystectomy: an audit of 500 patients. J Ayub Med Coll Abbottabad. 2011; 23(4):88–90. 14. Sato A. Ambulatory laparoscopic cholecystectomy: An audit of day case vs overnight surgery at a community hospital in Japan. World J Gastrointest Surg. 2013; 4(12):296. 15. Sharma A, Hayden JD, Reese RA, Sedman PC, Royston CMS, O'Boyle CJ. Prospective comparison of ambulatory with inpatient laparoscopic cholecystectomy: Outcome, patient preference and satisfaction. Ambul Surg. 2004; 11(1–2):23–6. 16. Al-Qahtani HH, Alam MK, Asalamah S, Akeely M, Ibrar M. Day-case laparoscopic cholecystectomy. Saudi Med J. 2015; 36(1):46–51. 17. Dimitriadis PA, Iyer S, Evgeniou E. The challenge of cancellations on the day of surgery. Int J Surg [Internet]. 2013; 11(10):1126–30. 18. Al-Omani S, Almodhaiberi H, Ali B, Alballa A, Alsowaina K, Alhasan I, et al. Feasibility and safety of day-surgery laparoscopic cholecystectomy: a single-institution 5-year experience of 1140 cases. Korean J Hepato-Biliary- Pancreatic Surg [Internet]. 2015; 19(3):109. 19. Hamid R, Hakeem W, Naiko Z, Malik M, Resident S. Annals of Surgery: International Feasibility of Day Care Laparoscopic Cholecystectomy in District Hospital Married doctors hostel room no= S2, A Block, SKIMS. Ann Surg Int. 2016; 2(2):6–10. 20. Tiryaki C, Bayhan Z, Ertugrul E, Alponat A. Ambulatory laparoscopic cholecystectomy: A single center experience. J Minim Access Surg. 2016; 12(1):47–53. 21. Ito E, Takai A, Imai Y, Otani H, Onishi Y, Yamamoto Y, et al. Quality of life after single-incision laparoscopic cholecystectomy : A randomized , clinical trial. Surgery [Internet]. 2019; 165(2):353–9. 22. Ji W, Ding K, Li L, Wang D, Li J. Outpatient versus inpatient laparoscopic cholecystectomy: a single center clinical analysis. Hepatobiliary Pancreat Dis Int. 2010; 9:60–4. JIIMC 2019 Vol. 14, No.3 135 Day Case Vs Conventional Laparoscopic Cholecystectomy