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A prospective study of ambulatory laparoscopic cholecystectomy

Surg Endosc (2005) 19: 1082–1085DOI: 10.1007/s00464-004-2170-y Ó Springer Science+Business Media, Inc. 2005 A prospective study of ambulatory laparoscopic cholecystectomy P. K. Jain, J. D. Hayden, P.C. Sedman, C. M. S. Royston, C. J. OÕBoyle Division of Upper Gastrointestinal and Minimally Invasive Surgery, Hull Royal Infirmary, Anlaby Road, Hull HU3 2JZ, United Kingdom Received: 7 July 2004/Accepted: 15 January 2005/Online publication: 26 May 2005 Laparoscopic cholecystectomy (LC) has become the Background: Even though ambulatory laparoscopic standard treatment for symptomatic cholelithiasis and cholecystectomy (ALC) is safe and cost effective, this the prevention of related complications [21]. The clinical approach has yet to gain acceptance in the United benefits are well established [2, 10], and more recently Kingdom. We report our 5-year experience of ALC with improvements in instrumentation, anesthesia, and peri- emphasis on its appropriateness for higher surgical operative care have made it possible to perform LC without the necessity for an overnight stay [1, 9, 16, 17, Methods: Between July 1997 and July 2002, patients with symptomatic cholelithiasis who met with appro- Ambulatory LC (ALC) has become routine practice priate criteria underwent ALC. Surgery was performed in the United States with several large series published either by a consultant surgeon or a higher surgical [16, 23]. These confirm not only the safety of this ap- trainee (HST) under direct supervision in our dedicated proach but also a reduction in procedural cost and high day surgery unit. Data were recorded prospectively and levels of patient satisfaction. In the United Kingdom, patients were interviewed postoperatively by an inde- there is currently a drive to increase the proportion of day case operations to 75% of all elective procedures [7].
Results: There were 269 patients (231 female and 38 However, ALC has been slow to develop in this country male) with a median age of 46 years (range 17–76).
despite the results achieved elsewhere.
Conversion to open cholecystectomy was necessary in Higher surgical training is currently undergoing three cases (1%). Of the patients, 79% (213) were dis- significant reappraisal as a result of the implementation charged within 8 hours of surgery; 95% (256) were dis- of the New Deal on junior doctorsÕ hours, Calmanisa- charged on the same day. Thirteen patients (5%) tion, and the European Working Time Directive [3, 5, 6, required overnight admission as inpatients. An HST 8]. These initiatives have reduced the duration and performed 166 (62%) of the procedures. There was a intensity of registrar training program and as a conse- statistically significant difference in operating time be- quence have raised concerns about the operative expo- tween consultants (41 min) and trainees (47 min, sure of higher surgical trainees (HST) [6] .The aim of P = 0.001) but no significant difference in clinical out- this study was to evaluate the outcome of ALC in our come or patient satisfaction. The mean procedural cost hands and to establish whether the day surgical unit to the hospital was £768 for ALC compared with £1430 could provide a safe training environment for what is for an inpatient operation. Of patients, 87% expressed considered an index procedure for higher surgical satisfaction with the day case operation.
Conclusion: Our results for ALC compare favorablywith published series. In addition, we have demon-strated that the operation can be performed safely by HST under direct supervision without compromisingoperating lists or safety.
Key words: Ambulatory surgery — Laparoscopic cho- All of the patients underwent surgery in our purpose-built day case unit at Hull Royal Infirmary. The unit is open from 07:00 until 21:00and is separate from the main hospital building. It is run by dedicatedmedical, nursing, and administrative staff. ALC was offered to patientswith symptomatic gallstone disease who met our established criteria: American Society of Anesthesiology (ASA) grade I or II, body mass Table 1. Comparison of outcome of ambulatory laparoscopic cholecystectomy with grade of operating surgeon HST, Higher Surgical TraineeValues are mean (s.d.)* or median (range).** t-test,  Mann-Whitney U test,à or chi square§ was used to analyze the data index <32 kg/m2. Patients who lived alone or more than 50 miles from version 11.5 (Chicago, IL, USA). Parametric and nonparametric data the hospital, or who refused an ambulatory procedure were offered a sets were compared using two-tailed t-test and Mann-Whitney U tests, conventional elective LC in the main hospital with an overnight stay.
respectively. The chi-square test was used to analyze categorical data.
Those with a history of jaundice, deranged liver function tests, or A p value of < 0.05 was considered statistically significant.
evidence of a common bile duct stone were subjected to preoperativecholangiography and, if necessary, stone extraction prior to surgery.
Patients who presented as an emergency with complications of gall-stones were dealt with on their index admission and therefore ex- Surgery was performed by one of the three consultant general surgeons with a subspecialist interest in minimally invasive surgery or Between July 1997 and July 2002, a total of 1025 pa- by a supervised HST. The trainees had been appointed to the unit as tients underwent elective LC at Hull Royal Infirmary.
part of their surgical rotation and typically had at least 3 years of Of these, 269 (26%) were performed in the day surgery registrar experience. All of the ALCs were performed on a morning unit. During the study, the proportion of LC performed list to allow time for recovery prior to closure of the unit in theevening.
as day cases increased from 18% in 1997 to 53% in 2002.
The average cost of the procedure was obtained from the financial The patients were predominantly female (86%). The department of the hospital for the subset of day case, and inpatient median age was 46 years (range 17–76). The majority of elective and nonelective laparoscopic cholecystectomy without the use patients were ASA I (88%) and the remainder were ASA of cholangiography. This does not include the cost of further admission II. Surgery was performed by a supervised HST in 166 for the complications in both the groups. The hospital cost was cal-culated for the procedure (admission, operating room, laboratory, pharmacy) and estimated cost for average length of stay in the hospital.
The duration of surgery (including induction) ranged from 30 to 112 min. No patient underwent intraopera-tive cholangiography. The overall mean (s.d.) operating time was 45 (16) min. Mean (s.d.) operating times forconsultants were significantly less than those for regis- A pneumoperitoneum was achieved using either veress needle insuf- trars, 41 (16) versus 47 (15) min, p = 0.001. There were flation or an open cannulation technique. Two 5-mm and two 10-mmports were introduced after local anesthetic infiltration with 0.5% no significant differences for postoperative pain or bupivicaine. Surgery was performed under general anesthesia with nausea scores or number of hospital admissions between endotracheal intubation. Induction was achieved with propofol (2 mg/ grades of operating surgeon (Table 1). The overall mean kg), fentanyl (1–5 lg/kg), morphine (10 mg), metoclopramide (10 mg), (s.d.) duration of stay on the day surgery unit was 496 Anesthesia was maintained with intermittent positive pressure (62) min. There was no significant difference in total ventilation, 33% oxygen, 60% nitrous oxide, and 1–3% sevoflurane, time spent in the day unit and the grade of surgeon.
which were adjusted according to individual requirements.
Discharge within 8 hours of surgery occurred in 213 Postoperative analgesic and antiemetic medication was titrated cases (79%) and in the same day in 256 (95%) patients.
with pain and nausea scores as recorded on a Linkert visual-analogue Temporary transfer to the main hospital surgical ward scale. Prescribed analgesia included paracetamol (mild pain), diclofe-nac or ketorolac (moderate pain), and morphine, tramadol, or codeine was required for 43 patients (16%) but overnight phosphate (severe pain). Antiemetic drugs included parenteral meto- admission was required for only 13 (5%). The most clopramide, cyclizine, and ondansetron. All patients were assessed by common reasons for delayed discharge were nausea and the anesthetist and the surgeon postoperatively and discharged home vomiting in 20 patients (7%) and minor intraoperative by the nursing staff when they were free from pain or nausea, able totake light diet, had successfully voided urine, and were ambulatory.
bleeding in 12 patients (4%) which had required place- They were instructed on how to contact the day surgery unit and given ment of an intraperitoneal drain at the time of surgery.
a supply of oral analgesia. Those who failed to meet with the discharge Conversion to open cholecystectomy was necessary in criteria were admitted to the inpatient surgical ward. All of the patients three patients (1%). The reasons for conversion were were voluntarily subjected to a telephone interview by an independent hemorrhage, common bile duct injury, and unusual observer on days 1, 2, 7 and weekly postoperatively until fully recov-ered. Persistent symptoms, patient satisfaction, and return to normal anatomy. The bile duct injury occurred in a patient with activity were assessed. Formal outpatient review was performed at 2 a thin mobile common bile duct that was damaged prior weeks following surgery. If there were no adverse sequelae, patients to accurate identification. The procedure was converted were discharged from the surgical service at this time.
to a laparotomy and a t-tube placed in the choledo-chotomy. The patient made an uneventful recovery andendured no adverse sequelae.
Readmission following discharge was necessary in Data were collected prospectively and analysis was performed using five patients (2%): Three were readmitted with pain and the Statistical Package for the Social Sciences software for Windows vomiting within 48 hours of discharge. One patient Table 2. Characteristics of patients admitted after ambulatory laparoscopic cholecystectomy Values are median (range)* or mean (s.d.).** Mann-Whitney U-test,   chi square,à or t-test§ was used to analyze the data Table 3. Average length of stay and hospital cost for laparoscopic cholecystectomy presented on day 3 with an intraabdominal bile collec- philosophy with respect to acute presentations of biliary tion, which was drained percutaneously. A further pa- disease (these patients undergo surgery during the index tient presented on day 3 with pain and jaundice due to a admission) and patient selection for day surgery (ASA I retained common bile duct stone that was extracted and II cases). However, there was a trend toward an endoscopically. The overall incidence of significant annual increase in the proportion of ALC, and by 2002, 53% of cholecystectomies were performed as day cases.
There was no significant difference in age, sex, ASA The proportion of ALC increased with experience and score, or grade of operating surgeon between patients this is consistent with published data [14, 20]. We expect who were admitted and those who were discharged to modify our day case selection criteria to include some (Table 2). The mean (s.d.) operating time was signifi- ASA III patients as others have done to further expand cantly longer for patients who required admission [58 (25) min vs 43 (12) min, p < 0.001]. Admission was Our clinical outcomes were similar to published more likely for those patients with higher postoperative series where there is a high proportion of same-day pain and nausea scores or those who vomited in re- discharges (up to 97%), low admission (<6%) and readmission rate (up to 5%), low levels of morbidity The mean procedural cost to the hospital was £768 (<3%), no mortality, and high patient satisfaction with for ALC compared with £1430 for an inpatient elective the procedure [16–19]. Where there is a delay in dis- operation (Table 3). At 2 weeks follow-up, 233 patients charge, overall patient satisfaction is reduced. Discharge (87%) were satisfied with their day surgery experience.
delay is associated with high postoperative pain and There was a significant difference in satisfaction scores nausea scores. Other authors have reported similar between those who were discharged on the same day findings [13]. There were no preoperative predictors of compared with those who were admitted (93% vs 51%, p < 001). There was no significant difference between We found that total operating time was significantly grade of operating surgeon and patient satisfaction (86% longer for supervised HST when compared with con- for HST vs 88% for consultants, p = 0.510).
sultants. Increased operating time was a risk factor foradmission as previously reported [13]. However, therewas no significant difference between the grade of operating surgeon and outcome in terms of postopera-tive pain and nausea scores, hospital admission, and With increasing experience and improvements in anes- patient satisfaction. This suggests that it is duration of thetic and surgical techniques, surgeons are gaining surgery rather than grade of operating surgeon that is confidence in the performance of ALC, especially in the associated with a more adverse outcome. This finding United States. However, there have been only a few may be attributable to the high degree of consultant reports of ALC from the United Kingdom, where the supervision involved and early intervention in difficult technique has been slow to develop [12, 18]. We have been performing ALC since 1997 and our data represent There is some evidence concerning the learning curve one of the largest prospective series in the United for LC. In the current study, the trainees had at least 3 Kingdom. During the current study, only 26% of LC years of registrar experience (with at least 50 supervised were performed as day case procedures. This relatively elective LC procedures). It has been reported that the small proportion reflects the case mix, our surgical unit frequency of complications, duration of hospital stay, and operating time for LC are reduced beyond the first 5. Calman KC, Temple JG, Naysmith R, Cairncross RG, Bennett SJ 25 cases [11]. After 35 cases the operating time may (1999) Reforming higher specialist training in the United King-dom—a step along the continuum of medical education. Med significantly decrease for some surgeons but not others, reflecting variability in the ability to acquire skills [4].
6. Chesser S, Bowman K, Phillips H (2002) The European There is a reported 40% reduction in operation time for Working Time Directive and the training of surgeons. Br Med J LC after 200 operations [22]; however, the constraints imposed on surgical training by the junior doctorsÕ new 7. Department of Health. Day surgery—operational guide. http:// deal on working hours and the recently implemented European Working Time Directive may lead to a sub- 8. Department of Health. European working time directive. http:// stantial increase in the number of HSTs and a reduction in exposure to elective and emergency cases, thus 9. Fleisher LA, Yee K, Lillemoe K, Talamini MA, Yeo CJ, Heath potentially limiting training opportunities [6]. This may RN, Bass E, Snyder DS, Parker S (1999) Is outpatient laparo- make such numbers difficult to achieve.
scopic cholecystectomy safe and cost-effective? A model to study The economic implications of ALC are considerable transition of care. Anesthesiology 90: 1746–1755 with a potential reduction in the cost of the operation by 10. Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, 11–25% per patient reported in some series [19, 23].
Osborne H, Bouchier-Hayes D (1991) Reduced postoperativehospitalisation after laparoscopic cholecystectomy. Br JSurg78: However in our unit the mean procedural cost of LC for 2002–03 was £768 for day case versus £1430 (46% dif- 11. Hawasli A, Lloyd LR (1991) Laparoscopic cholecystectomy: The ference) for the corresponding inpatient operation, Learning Curve: report of 50 patients. Am Surg 578: 542–544 making the financial benefits to the National Health 12. Huang A, Stinchcombe C, Phillips D, McWhinnie DL (2000) Prospective 5 year audit for day-case laparoscopic cholecystec- Service very substantial. In addition the ambulatory approach enables inpatient beds to be available for 13. Lau H, Brookes DC (2001) Predictive factors for unanticipated admissions after ambulatory laparoscopic cholecystectomy. Arch It is reassuring to confirm that one of the most important index training operations can be safely per- 14. Lau H, Brookes DC (2002) Transitions in laparoscopic cholecys- tectomy: the impact of ambulatory surgery. Surg Endosc 162: 323– formed by HSTs under direct supervision in the expanding environment of ambulatory surgery. The 15. Lillemoe KD, Lin JW, Talamini MA, Yeo CJ, Snyder DS, Parker widespread adoption of ALC may help to address some SD (1999) Laparoscopic cholecystectomy as a ‘‘true’’ outpatient of the emerging concerns regarding higher general sur- procedure: initial experience in 130 consecutive patients. JGas-trointest Surg 3: 44–49 gical training as well as having significant clinical and 16. Mjaland O, Raeder J, Aasboe V, Trondsen E, Buanes T (1997) Outpatient laparoscopic cholecystectomy. Br JSurg 84:958–961 17. Narain PK, DeMaria EJ(1997) Initial results of a prospective trial of outpatient laparoscopic cholecystectomy. Surg Endosc 11: Acknowledgments. The authors thank Jackie Tomlinson and the staff of the day case surgery unit for assistance with prospective data col- 18. Prasad A, Foley RJ(1996) Day case laparoscopic cholecys- lection and Anne Murray-Knagg for the procedural cost information.
tectomy: a safe and cost effective procedure. E JSurg 1621:43–46 19. Rosen MJ, Malm JA, Tarnoff M, Zuccala K, Ponsky JL (2001) Cost effectiveness of ambulatory laparoscopic cholecystectomy.
Surg Laparosc Endosc 11: 182–184 1. Alexander DJ, Ngoi SS, Lee L (1996) Randomised trial of peri- 20. Serra AS, Roig MP, Lledo JB, Santafe AS, Espinosa RG, Ber- portal peritoneal bupivicaine for pain relief after laparoscopic tomeu CA, Guillemot M, Casan PM (2002) The learning curve in cholecystectomy. Br JSurg 83: 1223–1225 ambulatory laparoscopic cholecystectomy. Surg Laparosc Endosc 2. Barkun JS, Barkun AN, Sampalis JS, Fried G, Taylor B, Wexler MJ, Goresky CA, Meakin JL (1992) Randomised controlled trial 21. Soper NJ, Stockmann PT, Dunnegan DL, Ashley S (1992) Lap- of laparoscopic versus mini cholecystectomy. The McGill Gall- aroscopic cholecystectomy: the new ‘‘gold standard’’? Arch Surg stone Treatment Group. Lancet 340: 1116–1119 3. Bates T (1996) Curricular training and the New Deal. Ann R Coll 22. Voitk AJ, Tsao SG, Ignatius S (2001) The tail of the learning curve for laparoscopic cholecystectomy. Am JSurg 1823: 250–253 4. Cagir B, Rangraj M, Maffuci L, Herz BL (1994) The learning 23. Zegarra RF, Saba AK, Peschiera JL (1997) Outpatient laparo- curve for laparoscopic cholecystectomy. JLaparoendosc Surg 46: scopic cholecystectomy: safe and cost effective? Surg Laparosc

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