Authors: Cagri Tiryaki, Zülfü Bayhan, Ertugrul Kargi, Ahmet Alponat
Categories: Original Article, Ambulatory laparoscopic cholecystectomy, anxiety, nausea, pain
Source: Journal of Minimal Access Surgery
To evaluate the demographic and clinical parameters affecting the outcomes of ambulatory laparoscopic cholecystectomy (ALC) in terms of pain, nausea, anxiety level, and satisfaction of patients in a tertiary health center.
ALC was offered to 60 patients who met the inclusion criteria. Follow-up (questioning for postoperative pain or discomfort, nausea or vomiting, overall satisfaction) was done by telephone contact on the same day at 00 p.m. and the first day after surgery at 00 a.m. and by clinical examination one week after operation. STAI I and II data were used for proceeding to the level of anxiety of patients before and/or after the operation.
Sixty consecutive patients, with a mean age of 40.6 ± 8.1 years underwent ALC. Fifty-five (92%) patients could be sent to their homes on the same day but five patients could not be sent due to anxiety, pain, or social indications. Nausea was reported in four (6.7%) cases and not associated with any demographic or clinical features of patients. On the other hand, pain has been reported in 28 (46.7%) cases, and obesity and shorter duration of gallbladder disease were associated with the increased pain perception (P = 0.009 and 0.004, respectively). Preopereative anxiety level was significantly higher among patients who could not complete the ALC procedure (P = 0.018).
Correct management of these possible adverse effects results in the increased satisfaction of patients and may encourage this more cost-effective and safe method of laparoscopic cholecystectomy.
Keywords: Ambulatory laparoscopic cholecystectomy, anxiety, nausea, pain
The prevalence of gallstone disease is reported as 5%-27% in the general adult population.[1] Although 80% of the cases remain asymptomatic, it is essential to define the most appropriate way of treatment of this very common disease.[2] Laparoscopic cholecystectomy (LC) is one of the most common operations performed worldwide.[3] With its many benefits, including reduced postoperative pain, smaller scars, shorter hospital stay, shorter convalescence period, and decreased risk of selected complications compared with open cholecystectomy, it is regarded as a minimally invasive surgery for both patients and surgeons.[4,5] However, the majority of patients undergoing elective LC are still observed in the hospital overnight that makes the patient anxious and on the other hand puts a burden for the economy.[6]
Nowadays, the popularity of day-case surgery continues to grow owing to its greater patient quantity, lower staff and surgical costs, and more personalized care.[7] In recent studies, ambulatory surgery has been determined as safe with its rare major morbidities and seldom readmission requirements.[8,9] In that aspect, overall patient satisfaction has been shown to be high.[10] The main causes of readmission or delay in hospital stay after ambulatory laparoscopic cholecystectomy has been defined as nausea, vomiting, or uncontrolled pain.[11,12]
The aim of this study was to evaluate the demographic and clinical parameters affecting the outcomes of ambulatory LC (ALC) in terms of pain, nausea, anxiety level, and the overall satisfaction of patients in a tertiary health center. We believe that, if factors affecting the outcomes can be clearly defined, patient selection for ALC would be more logical for surgeons.
This was a prospective study carried out in Kocaeli University Hospital. The indication for surgery was ultrasound-documented symptomatic chronic cholelithiasis, without clinical or radiological evidence of acute cholecystitis in all patients.
ALC was offered to 60 patients who met the following established inclusion Age 18-70 years; American Society of Anesthesiology (ASA) physical status classification class I, II, or III; patient acceptance and cooperation (informed consent); presence of a responsible adult to accompany the patient during his residency and staying with him overnight. Prior upper abdominal surgery or body mass index (BMI) > 30 kg/m^2^ were not regarded as exclusion criteria. All patients were informed about same-day discharge.
The study protocol was approved by the Ethics Committee of Kocaeli University Medical Faculty and written informed consent was obtained from all patients.
In the preoperative period, history, physical examination, and standard laboratory and radiological tests of all patients were determined. Age, gender, educational level, job, marriage status, BMI, white blood cell count, liver function tests, history of prior abdominal surgery, the findings of hepatobiliary ultrasound, and the risk group of patients according to the ASA were all recorded.
Surgery was performed by consultant surgeons. All ALCs were scheduled on a morning list before the 00 am, in order to permit enough time for patient recovery prior to the night.
All patients were examined by a consultant anesthesiologist in the outpatient clinic the day before surgery.
In the operating room, patients were attached to a standard hemodynamic monitoring (electrocardiogram, oxygen saturation, heart rate, and noninvasive blood pressure). After inserting a peripheral venous catheter (18G), all patients received 0.03 mg/kg intravenous (iv). Midazolam (Dormicum, Roche, İstanbul). Then after preoxygenation for 3 min, anesthesia was induced with 2 mg/kg iv. Propofol (Propofol-Fresenius 2%, Fresenius Kabi, Graz, Austria), 1 μg/kg iv. Remifentanyl (Ultiva, Glaxo-Smith-Kline, England) and 0.1 mg/kg Rocuronium (Esmeron, Organon, Oss, Holland). Mechanical ventilation was used after intubation. To maintain anesthesia, we administered 5%-6% Desflurane and 50% oxygen + 50% azote protoxide and Remifentanyl infusion. Prior to extubation (15 min) intravenously 100 mg Tramadol (Contramal, Abdi İbrahim, Istanbul) and 4-8 mg Ondansetron (Zofer, Adeka, Samsun) were administered. To control postoperative pain, local infiltration of trocar sites with ropivacaine was also performed. Standard American four-port technique was used for the operation.
For the discharge, the following criteria were used 8 h after the Awake, oriented, mobilized, and tolerating oral fluids; passage of urine; no postoperative pain, nausea or vomiting; stable general condition for at least 2 h evaluated by the consultant surgeon and anesthesiologist.
Follow-up (questioning for postoperative pain or discomfort, nausea or vomiting, overall satisfaction) was done by telephone contact on the same day at 00 hours and the first day after surgery at 00 hours and by clinical examination on an outpatient basis one week after operation.
Nausea was regarded as present or not according to the patients’ affirmance. For the antiemetic purposes, 10 mg metoclopramide was used if necessary.
Pain was followed in all patients in 4^th^ and 8^th^ h after surgery by using visual analog scale (VAS) (0: No pain, Intolerable pain). Patients with a pain of greater than 3 points were regarded as having pain and 8 mg Lornoksikam was used as the additional analgesic treatment.
The satisfaction of patients from ALC was evaluated by clinical examination on an outpatient basis on the 7^th^ day after operation.
STAI I (state) and STAI II (trait) data were used for proceeding the level of anxiety of patients before and/or after the operation. STAI data are questionnaires of 20 items each, which are first described and developed by Spielberger et al.[13] They are usually administered as self-completion questionnaires. STAI I was administered in preoperative period and at postoperative 8^th^ h, just before the externalization. However, STAI II was only performed in preoperative period. The higher the results of these questionnaires means the lower the level of anxiety.
During this study it has been planned that externalized patients in need of readmission will be evaluated by the corresponding doctor; their symptoms responsible for the re-admission will be recorded and if the reason cannot be overwhelmed in a short time, the patient will be re-hospitalized and excluded from the study.
All analyses were performed with the Statistical Package for Social Sciences (SPSS, Inc., Chicago, IL, USA) for Windows 17.0 program. The association of demographic features and laboratory data with perioperative nausea and pain and satisfaction level of patients after ALC were determined with Pearson X2 tests. On the other hand, the association of STAI I and II results with nausea and pain was determined with Kruskal-Wallis test and the association of STAI I and II results with satisfaction level of patients was determined with Mann-Whitney U test. The P < 0.05 was considered as statistically significant.
Sixty consecutive patients, with a mean age of 40.6 ± 8.1 years fulfilling the inclusion criteria underwent an ALC in Kocaeli University Hospital. Among those patients, 45 (67%) were female. Fifty-five (92%) patients could be sent to their homes after 8 h of follow-up but five patients could not be sent. The reasons of relinquish from ALC were high anxiety levels (n:2) and social indications (n:2, they were health staff). In only 1 patient, the doctor decided to relinquish from ALC and to continue the patient's hospital stay owing to the ongoing pain of the patient at the 8^th^ h. This pain was resolved at the 16^th^ h after surgery and the patient was externalized at the 24^th^ h. In other four cases, there was not any symptoms seeking medical assistance and they were also externalized at the 24^th^ h.
When patients were evaluated according to their BMI, 38 (63,3%) were having normal weight, whereas 18 (30%) were overweight and 4 (6.7%) patients were obese. Twenty patients (33.3%) had previously undergone upper abdominal surgery. The majority of patients were ASA I (78.3%) whereas the remainder was ASA II; there were no ASA III patients.
Gallstone was visualized by ultrasound in all cases. The diameter of gall stone was ≤10 mm in 32 (53.3%) cases and, >10 mm in 28 (46.7%) patients. All operations could be completed as laparoscopic interventions, and conversion to open surgery was not necessary in any operations. In none of the cases intraoperative cholangiography was necessary.
During operation, edema and pledges were present in two cases (3.3%). Any intraoperative complication was not observed in 59 cases but one patient had intraoperative bleeding. The duration of surgery was shorter than 60 min in 43 (71.7%) cases and the total anesthesia time was shorter than 75 min in 43 (71.7%) patients.
In postoperative period, nausea was reported in four (6.7%) patients in first 4 h and also continued in the second 4 h. Metoclopramide was administered to all cases with nausea. Nausea continued in those four cases after externalization and controlled at the 16^th^ h after operation. When demographic and clinical factors, including age, gender, BMI, educational level, history of prior surgery, number of attacks, number of stones, gall bladder wall thickness, liver function tests, operation time, and anesthesia time were evaluated; none of the parameters were significantly associated with the nausea.
Postoperative pain was reported in totally 28 (46.7%) cases after surgery. In all cases pain started in the first 4 h after surgery but continued through the second 4 h in only six (10.0%) cases. Lornoxicam (im) was administered to all cases with pain. Intravenous analgesic administration was not required in any cases in the first 8 h after surgery. In 23 (38.3%) cases, pain was also present at home and they required oral analgesics, which controlled the pain. In correlation analysis, there was a negative significant correlation between pain and obesity (P = 0.009) [Table 1]. Interestingly, gallbladder stone disease period of shorter than 1 year was also negatively correlated with pain perception (P = 0.004).
When the results of STAI questionnaires were evaluated; the mean preoperative anxiety test results was 45.0±5.48 (range: 35-62) and the mean postoperative anxiety test results was 48.00 ±6.01 (range: 38-62). There was not any association of STAI results with pain and nausea. However, when patients were evaluated according to their satisfaction level of ALC, five patients who could not complete the procedure were regarded as unsatisfied and their preoperative anxiety level was significantly higher than that of satisfied patients (P = 0.018) [Table 2].
At the 7^th^ day control, all 55 patients who completed the ALC procedure were satisfied with the technique and the other five patients who could not complete the procedure also told that it would be better if they did not pass the operation night at hospital. However, because all patients completed the procedure were satisfied and the number of patients relinquished ALC was very low (n:5), the factors affecting the satisfaction of patients after ALC could not be evaluated.
In this study we have determined that, nausea is reported in a small amount (6.7%) of patients operated with ALC procedure and not associated with any demographic or clinical features of patients. On the other hand, pain has been reported in a higher percentage (46.7%) and obesity and shorter duration of gallbladder disease were associated with the increased pain perception. However, patients who reported to have pain after operation were also satisfied with the procedure. Although the preoperative or postoperative anxiety levels did not affect the postoperative nausea or pain; significantly increased preoperative anxiety was determined among cases who could not complete the ALC procedure.
LC in an ambulatory setting has been determined as a safe alternative to the traditional overnight hospital stay before.[14] In a cohort of 1600 consecutive patients undergoing elective LC, ALC was reported to be successfully performed in 80.8% of cases with a re-admission rate of 1.6% and mortality rate of 0.08. In that aspect, ALC is concluded as a reliable and safe procedure.[15] In a recent review of six trials involving 492 participants undergoing day-case laparoscopic cholecystectomy (n = 239) versus overnight stay laparoscopic cholecystectomy (n = 253) for symptomatic gallstones, no significant difference was determined in the rate of serious adverse events, pain, time to return to activity, and hospital readmission rates between the two groups.[16]
Postoperative nausea is one of the main factors that may influence postoperative discharge and hospital stay.[17] In a recent study of 69 LC cases, the most common reasons for unexpected or prolonged hospital stay were nausea and vomiting in both day case (8%) and overnight LC groups (5.2%).[18] In that study, the ratio of postoperative nausea was not much higher than our result of 6.7%; however, presence of nausea caused prolonged hospital stay in that study but not affected the hospital stay or satisfaction level of patients in our study. Ondansetron administered to all patients prior to extubation may be the reason of lower incidence and milder results of nausea in our study. The routine use of prophylactic antiemetic agents such as ondansetron may reduce the incidence of postoperative nausea and vomiting and their effects.[19] In a study of 54 adults the palonosetron-dexamethasone combination was more effective as compared to only palonosetron for reducing postoperative nausea and vomiting, whereas intravenous injection of 8 mg Dexamethasone or 3 mg Granisetron before anesthesia induction had similar effects in prophylaxis of nausea and vomiting after laparoscopic cholecystectomy in another study.[20,21] However, we did not administer dexamethasone but ondansetron in our study for antiemetic purposes.
Pain following the operation is one of the most important factors causing morbidity, mortality, and prolonged hospital stay among patients undergoing LC.[22] Preoperative administration of nonsteroidal anti-inflammatory drugs (NSAIDs) or COX II inhibitors has been shown to decrease postoperative pain scores and requirement for postoperative opioid analgesia in laparoscopic cholecystectomy.[23,24] Preoperative administration of NSAIDs or COX II inhibitors is also advised for ALC for postoperative pain control.[25] In a recent study, different administration methods of diclofenac sodium has been compared and, in patients undergoing ambulatory laparoscopic cholecystectomy, a noninvasive application of transdermal diclofenac sodium has been shown to be as effective as intramuscular diclofenac sodium, which can be preferred in postoperative pain treatment.[26] Gabapentin 1200 mg and pregabalin 150 mg, have also been determined as effective and safe analgesics for reducing postoperative pain in laparoscopic cholecystectomy.[27] Interestingly, the combination of gabapentin, ketamine, lornoxicam, and local ropivacaine does not provide superior analgesia than gabapentin alone or lornoxicam alone after laparoscopic cholecystectomy in a two-center randomized placebo-controlled trial of 148 patients.[28] Tramadol was administered prior to the extubation, and ropivacaine was used on the trocar sites for local analgesic effects in our study. Although the ratio of patients who felt pain after ALC was high (46.7%), this did not affect the satisfaction of patients. Intravenous tramadol has been reported to provide superior analgesia in the early postoperative period after laparoscopic cholecystectomy compared with an equivalent dose of tramadol administered intraperitoneally and with normal saline.[29] On the other hand, ropivacaine has been shown to have significant favorable effects on postoperative pain after laparoscopic cholecystectomy when using both parietal and intraperitoneal instillation.[30]
Interestingly, we have determined that increased BMI also increased the pain perception significantly. In a study by Robinson et al., on 269 ALC cases, age, ASA class, and duration of surgery were determined to be the factors related to the failure of same-day discharge but not the BMI, liver function tests, and ultrasound findings.[31] Obesity and even morbid obesity have been determined not to increase the morbidity after laparoscopic surgery.[32] In that aspect, ambulatory LC can be performed also among obese cases.
In a study by Bona et al., 92% of the cases were discharged on the same day and 8.0% were admitted for pain control or postoperative anxiety/discomfort.[33] Similar with our results, preoperative anxiety was one of the main factors affecting the hospital stay in that study. In that aspect, enlightening patients about the general surgical procedure and decreasing their anxiety level may be helpful in increasing the satisfaction level and diminishing hospital stay length. In another study, high preoperative anxiety level has been reported to have negative effects on recovery from anesthesia and control of postoperative pain increasing need for postoperative analgesia.[34]
This study has many limitations. First of all this is not a cross-sectional study and we did not compare the outcomes of ALC with the group of one-night hospital stay. However, because the main aim of the study was determining the factors affecting the outcomes of ALC, this is not a major limitation. Second, the number of patients unsatisfied with the procedure was very low also limiting the statistical power; but this limitation increases the facility of the ALC procedure.
In conclusion, nausea or pain did not affect the satisfaction level of patients in this study. However, increased preoperative anxiety levels caused a significant increase in the number of patients who could not be sent home on the same day of the operation. Correct management of these possible adverse effects results in the increased satisfaction of patients and may encourage this more cost-effective and safe method of laparoscopic cholecystectomy.