BACKGROUND: In the last decade, laparoscopic cholecystectomy (LC) has become a regular daycare surgery at many centres across the world. However, only a few centres in India have a dedicated daycare surgery centre, and very few of them have reported their experience. Concerns remain regarding the feasibility, safety and acceptability of the introduction of daycare laparoscopic cholecystectomy (DCLC) in India. There is a need to assess the safety and acceptability of the implementation of short-stay DCLC service at a centre completely dedicated to daycare surgery. PATIENTS AND METHODS: Comprehensive care and operative data were retrospectively collected from a daycare centre of our hospital. Postoperative recovery was monitored by telephone questionnaire on days 0, 1 and 5 postoperatively, including adverse outcomes. RESULTS: A total of 211 patients were admitted for DCLC during the period from November 2011 till November 2014, of whom 211 were discharged on the day of surgery. Two hundred and two patients could be discharged within 6 h of surgery. Mean operation time was 72 min. No patient required admission. No patient needed conversion to open surgery. Only 1 patient was re-admitted due to bilioma formation and was managed with minimal intervention. CONCLUSION: The introduction of short-stay DCLC in India is feasible and acceptable to patients. High body mass index (BMI) in otherwise healthy patients and selective additional procedures are not contraindications for DCLC.
BACKGROUND: In the last decade, laparoscopic cholecystectomy (LC) has become a regular daycare surgery at many centres across the world. However, only a few centres in India have a dedicated daycare surgery centre, and very few of them have reported their experience. Concerns remain regarding the feasibility, safety and acceptability of the introduction of daycare laparoscopic cholecystectomy (DCLC) in India. There is a need to assess the safety and acceptability of the implementation of short-stay DCLC service at a centre completely dedicated to daycare surgery. PATIENTS AND METHODS: Comprehensive care and operative data were retrospectively collected from a daycare centre of our hospital. Postoperative recovery was monitored by telephone questionnaire on days 0, 1 and 5 postoperatively, including adverse outcomes. RESULTS: A total of 211 patients were admitted for DCLC during the period from November 2011 till November 2014, of whom 211 were discharged on the day of surgery. Two hundred and two patients could be discharged within 6 h of surgery. Mean operation time was 72 min. No patient required admission. No patient needed conversion to open surgery. Only 1 patient was re-admitted due to bilioma formation and was managed with minimal intervention. CONCLUSION: The introduction of short-stay DCLC in India is feasible and acceptable to patients. High body mass index (BMI) in otherwise healthy patients and selective additional procedures are not contraindications for DCLC.
Laparoscopic cholecystectomy (LC) is now widely accepted as the treatment of choice for symptomatic gall bladder disease. Improvements in operative and anaesthetic techniques and increased familiarity with the procedure have led to progressively shorter hospital stays.[1] However, fewer data are available regarding the acceptability and feasibility of the introduction of LC with same-day discharge in a dedicated daycare centre. Some recent publications have reported safe same-day discharge after LC, with complication and re-admission rates similar to those procedures performed on patients with overnight observation.[234567] However, there are insufficient data on the difficulties of introducing this service to existing daycare units in India, particularly dedicated daycare centres. Most of the available literature mentions 6-18 h of hospital stay after daycare laparoscopic cholecystectomy (DCLC). We consider a short stay (5-6 h) to be feasible in selected planned cases of LC. It reduces the cost, making it possible to operate in a higher number of cases without added risk to the patients.In October 2011, we started performing LC in a dedicated daycare hospital. Staff from our main theatres initially worked alongside day-unit personnel to facilitate their training in the key skills of laparoscopic surgery. Subsequently, a retrospective audit of all patients undergoing DCLC was conducted. Comprehensive data have been collected on the surgical procedures, recovery period, postoperative pain and other parameters.
PATIENTS AND METHODS
All patients listed for LC were considered for day surgery. This included patients seen in the outpatient clinic with symptoms consistent with biliary colic and an ultrasound scan confirming gallstones, who were willing to undergo DCLC. In addition, patients awaiting interval cholecystectomy following resolved acute cholecystitis were also considered for daycare surgery. Patients needing other minor surgical procedures along with cholecystectomy (septoplasty, hernioplasty, appendicectomy, lateral anal sphincterotomy) were also included in the study.Patients with a body mass index (BMI) >38 kg/m2, an American Society of Anesthesiologists (ASA) score of 3 or higher, complicated biliary disease (evidence of common bile duct stones or previous endoscopic retrograde cholangiogram, severe pancreatitis, recurrent admissions with cholecystitis) and previous extensive abdominal surgery were considered unsuitable for daycare surgery and excluded. However, patients with abnormal liver function tests (raised alkaline phosphatase and gamma glutamyl transferase) but a normal preoperative magnetic resonance cholangiopancreatogram (MRCP) were eligible for DCLC. In some studies, living within a defined area was considered as an important criterion for inclusion of a patient, but in our study patients from distant places who were accompanied by another person and who were willing to manage accommodation near the hospital for at least 2 days were also included.All patients were required to have a responsible adult available to accompany them home (or to rented accommodation) and stay with them for 48 h. A retrospective database of all included patients was established, and operative and perioperative details throughout the daycare centre episode were evaluated.
Operative technique
All patients were admitted on the day of surgery at 7 AM, having been nil-by-mouth from midnight. LC was commenced before 1 PM, with up to two cases performed by a single surgeon. All surgeries were done under general anaesthesia followed by bilateral transverse abdominis plane (TAP) block using Sensorcaine as an agent according to safe weight-calculated doses. Two consultant surgeons performed all procedures, with closed cannulation using Veress needle, a 10-mm port through a sub-umbilical incision and three further ports, one epigastric (10-mm) and two standard right upper quadrant (5-mm), under laparoscopic vision. Intra-abdominal pressure was maintained at 12-14 mmHg. Saline lavage and suction was performed in cases of bile spillage at the end of each procedure. On closure, no anaesthetic agent was administered to the port sites. One gram intravenous ceftriaxone was administered as antibiotic prophylaxis before the skin incision. Another dose was given at the time of discharge in cases of bile spillage.
Anaesthetic/postoperative management
All patients received preoperative ondansetron (4 mg), 1 h before surgery. Mechanical antithrombotic measurement (sequential compression device) was used only for high-risk patients for deep venous thrombosis. All procedures were done under general anaesthesia. Intravenous fluids were given to maintain hydration. On transfer to the postanaesthetic care unit, intravenous fluids were discontinued after 3 h if observations were satisfactory. In the recovery area, patients were encouraged to mobilise after 4 h of surgery and offered progressive oral diet as tolerated.All patients were planned for discharge at 5-6 h after surgery. Patients staying >6 h after surgery were considered as long-stay. Pain scoring was done by the visual analogue scale (VAS). On discharge, patients were provided with a supply of tablet pantoprazole and paracetamol as per weight-adjusted dose for 5 days. In those patients in whom non-steroidal anti-inflammatory drugs were contraindicated, paracetamol was substituted with tramadol tablets. Wound care advice and literature was given, along with contact numbers for the daycare unit. Patients were also given details of how to contact the on-call surgeon in the event of experiencing severe symptoms as listed in their information booklet.
Follow-up
All patients were asked to follow up in outpatient on postoperative day 1. In the first 2 weeks after surgery, all patients were telephoned on days 5 and 14 by the daycare nursing staff and interviewed using a standardised questionnaire. Contact with healthcare professionals, patient satisfaction, pain, nausea control and any complications were recorded.
Statistical method
Data entry was done in MS-Excel 2007 (Microsoft Corporation) spread sheet. All the data analysis and validation were carried out using SPSS (Ver. 11.0) (IBM Corporation). All the continuous variables were assessed for normality using the Shapiro–Wilk test. If the variables were normally distributed, they were expressed as mean ± standard deviation, otherwise as median (interquartile range). All the categorical variables were expressed either as percentage or proportion. Comparisons of all the normally distributed continuous variables were done by independent sample t-test or analysis of variance (ANOVA) based on the number of the groups. Comparison of all the non-normally distributed continuous variables was done by the Mann–Whitney U test. Comparison of categorical variables was done by either chi-square test or Fisher's exact test based on the number of observations. All P values < 0.05 were considered as statistically significant.
RESULTS
Between November 2011 and November 2014, 211 patients underwent intended DCLC at our hospital. The mean age at operation was 42 years (range, 12-78 years) and 115 (54.5%) patients were female. The mean BMI was 28 kg/m2 and 40 patients had BMI >30 kg/m2. The average duration of surgery was 72 min [Table 1].
Table 1
Demography and surgery duration
Demography and surgery durationOne hundred thirty-three patients (78%) were classified ASA-1 and 78 (37%) were ASA-2. There was no unplanned admission, and all patients were discharged on the same day as surgery. Two hundred five patients underwent LC only, whereas 6 patients had combined surgeries [Table 2].
Table 2
Type of surgery and re-admission
Type of surgery and re-admissionAll 211 patients were successfully discharged on the day of surgery. Two hundred two patients could be discharged within 6 h of surgery, while 9 patients were discharged 6-8 h after surgery [Table 3]. Five out of 9 patients had combined surgery with LC (P value < 0.000) and all of them had surgery duration of more than 100 min (P value < 0.000). Late discharge was for poor mobilisation and need of longer observation, as decided by the operating surgeon. Post operative pain assessment was done using visual analogue scale (VAS) [Table 4].
Table 3
Comparison of short-stay and long-stay DCLC
Table 4
Assessment of postoperative pain
Comparison of short-stay and long-stay DCLCAssessment of postoperative painTwo patients had parietal wall haematoma following TAP block, which was managed conservatively. Two patients had drain placed during surgery and removed on the first postoperative day (BMI 31 each). Mean age of patients was 42.3 years and 53.9 years for short stay and long stay, respectively. Gender and drain placement did not affect the duration of stay (P values 0.51 and 0.083, respectively).Only 1 patient required re-admission on the first postoperative day, for bilioma formation due to bile duct injury. It was diagnosed postoperatively and managed with drainage of collection and endoscopic stenting of the biliary duct. On day 14, on follow-up questionnaire, 201 patients were recorded as independent of support within 4 days of surgery and 178 had restarted work within 7 days of surgery.
DISCUSSION
DCLC has been adopted as a safe and viable procedure, and is rapidly gaining popularity because of cost saving and convenience. Fewer complications during the intraoperative or immediate postoperative periods further justifies the rapid growth of this type of ambulatory surgery in developed nations.[891011] However, data from developing nations such as India are sparsely available. A centre without previous experience and without the infrastructure to support major daycare surgery needs to develop well-reasoned guidelines with a rigid and honest appraisal of outcomes to identify deficiencies and potential pitfalls. We started performing daycare surgery at a dedicated daycare centre from November 2011. Though such dedicated daycare centres are increasing in number in recent years, less data are available regarding the outcome of daycare procedures in such hospitals. The recent experience from India has reported it to be safe, feasible and acceptable to patients, with social and economic benefits.[111213141516] Though 60-81% successful discharge rate was reported in earlier era of DCLC, it gradually increased to >90%.[12171819] [Table 5] summarises the experiences reported in the literature.
Table 5
Daycare laparoscopic cholecystectomy (LC) results
Daycare laparoscopic cholecystectomy (LC) resultsPerforming DCLC in high-risk patients presents a challenge to surgical safe practice, particularly during the early postoperative period. Advancements in the field may help to broaden the eligibility for daycare procedures, but it should not be at the cost of increased morbidity or mortality. Saunders et al. have reported mortality after DCLC, thereby advocating caution before performing this procedure in a daycare setting.[20] The criteria for patient selection are crucial for the development of safe daycare surgery. ASA classification, performance status, comorbidities, procedural duration and surgery start time have been identified as factors associated with failure in outpatient management.[21] It is well known that appropriate patient selection lowers the failure rate; patients most likely to fulfill the criteria for DCLC are patients of ASA grades I and II, with no previous abdominal surgery, no history of acute cholecystitis and a cholecystectomy duration of shorter than 90 min.[132223] Most studies utilise selection criteria when evaluating patients for DCLC.[824] Ali et al. reported successful DCLC in 92% of selected patients.[25] Chauhan et al. reported a success rate of 96.1%. And the most common reason for exclusion from DCLC was distant residence of patient (57%) outside the defined area.[12] In our study, we have included the patients from distant places who were willing to make their own arrangements for at least 2 days in the city of surgery. Our study also includes the other selective procedures that have been combined with DCLC and proved to be feasible. Operative time and duration of daycare stay were increased in these cases, but patients were still discharged within 8 h of surgery. A recent study from tertiary health center in north India have mentioned the maximum duration as 8 h in 309 patients of DCLC.[26] A duration less than 6 h, as shown in our study, is considered as ‘short stay’ or ‘ultra short stay’ in daycare surgery. The minimum postoperative duration of hospital stay was 4 h in selected cases of our study. Patients as young as 12 years and as old as 78 years underwent DCLC in our study. Age and sex had no influence on the duration of postoperative hospital stay. Unlike most of the studies, this study included patients with BMI up to 35 without other risk factors for DCLC. Higher-BMI (>30) patients had a longer duration of stay after surgery but were discharged as daycare patients within the stipulated time. Though selection criteria remains the most important factor deciding the outcome of DCLC, the norms can be broadened with respect to such criteria as locality or other procedures combined with DCLC. However, while choosing short-stay daycare surgery, it is better to avoid combination surgeries. The rate of unplanned admission in DCLC is a quality index, as it might represent the existence of inadequate criteria in the selection of patients who, given their characteristics, precedents or preoperative findings, were not candidates for this type of surgery. A lower admission rate has been reported in freestanding ambulatory surgery centres and this could be related to their strict patient selection criteria.[202122] In our study, only 1 patient required re-admission in the postoperative period. There was zero mortality and no re-operation. Two patients had parietal wall haematoma following TAP block and were managed as outpatients. In this study, drain was placed in 2 cases, which did not affect the postoperative outcome.
CONCLUSION
Short-stay DCLC at a dedicated daycare centre is feasible, safe and effective if performed in a select group of patients after establishing strict patient selection criteria. Select combined procedures with DCLC are feasible but they increase hospital stay. Though not suitable for short-stay surgery, patients with higher BMI up to 35 without other risk factors may be considered for DCLC.
Authors: A Kumar; V Seenu; N Mohan; A Kaul; A P Bhalla; R K Batra; K Mandal; S Aggarwal Journal: Natl Med J India Date: 1999 May-Jun Impact factor: 0.537