Journal of Clinical Anesthesia (2016) 34, 85–90
Original contribution
Outpatient laparoscopic sleeve gastrectomy: first 100 cases☆,☆☆ Rachid Badaoui MD a,⁎, Youssef Alami Chentoufi MD a , Abdelhakim Hchikat MD a , Lionel Rebibo MD b , Ivan Popov MD a , Abdennaceur Dhahri MD b , Ghada Antoun MD a , Jean-Marc Regimbeau MD b , Emmanuel Lorne MD a , Hervé Dupont MD a a
Department of Anesthesiology and Critical Care, Amiens University Medical Center, Avenue René Laennec, F-80054, Amiens cedex 01, France b Department of Digestive Surgery, Amiens University Medical Center, Avenue René Laennec, F-80054, Amiens cedex 01, France Received 8 January 2016; revised 3 March 2016; accepted 5 March 2016
Keywords: Obesity; Sleeve gastrectomy; Bariatric surgery; Laparoscopy; Ambulatory; Anesthesia
Abstract Study objective: The development of outpatient surgery was one of the major goals of public health policy in 2010. The purpose of this observational prospective study was to evaluate the feasibility of laparoscopic sleeve gastrectomy (SG) in an ambulatory setting. Design: Study design was a prospective prospective observational, nonrandomized study, registered (ClinicalTrials.gov identifier: NCT01513005), with institutional review board approval and written informed consent. Setting: Amiens University Medical Center. Patients: Patients undergoing SG who were preselected by inclusion ambulatory criteria. Interventions: All patients operated on for obesity by laparoscopic SG, from May 2011 through July 2013. Measurements: We collected outcomes data on 100 patients including incidence of postoperative nausea and vomiting, maximum and average pain scores, and the overall satisfaction rate. Main results: Of the 100 obese patients, 93% were women. The mean age was 36 years (22-55 years). The mean preoperative body mass index was 42.4 kg/m2. The mean operating time was 60 minutes (range, 30-95 minutes). The overall satisfaction rate was 93% (n = 93). When leaving the postoperative care unit, 94% of patients felt no or mild pain. Eighty-two percent had no postoperative postoperative nausea and vomiting, and 7 patients needed treatment using ondasetron. Conclusions: Laparoscopic SG in an ambulatory setting is feasible with a dedicated anesthesiological approach and an expert surgical team. Appropriate patient selection is important for ensuring safety and quality of care within the outpatient program. © 2016 Elsevier Inc. All rights reserved.
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Funding: NO. All authors declare that they have no conflict of interest. ⁎ Corresponding author at: Department of Anesthesiology and Critical Care, Amiens University Medical Center, Avenue René Laennec, F-80054 Amiens cedex 01, France. Tel.: +33 3 22 66 83 75; fax: +33 3 22 66 83 74. E-mail address:
[email protected] (R. Badaoui).
1. Introduction
☆☆
http://dx.doi.org/10.1016/j.jclinane.2016.03.026 0952-8180/© 2016 Elsevier Inc. All rights reserved.
Obesity is a metabolic disorder that is on the rise worldwide as well as in France [1]. There is a directly proportional relationship between excessive weight and morbidity-mortality
86 linked to cardiovascular disease, diabetes, obstructive sleep apnea (OSA) syndrome, and some types of cancer [2,3]. The relation between weight loss and reduction of these complications is well demonstrated. Bariatric surgery increases life expectancy by correcting the comorbidities associated with obesity [4], improves quality of life [5], and is associated with reduced morbidity and mortality [6]. With the use of ambulatory anesthesia, the patient stays less than 12 hours in the care facility before he or she returns home [7]. The reasons for developing ambulatory surgery are that it allows one to reduce hospital costs, enables staff to devote more time to hospitalized patients requiring more demanding care, and reduces the incidence of nosocomial infection. Bariatric ambulatory surgery was initially performed in cases of gastric banding [8,9]. Among bariatric procedures, sleeve gastrectomy (SG) has become very popular due to its relatively short and simple procedure, with a mean operating time of 100 minutes [10–13] and low postoperative complication rates [14]. We think that this type of surgical procedure responds to all the criteria necessary for ambulatory care. The purpose of this prospective observational single-center study was to evaluate the feasibility of laparoscopic SG in an ambulatory care setting.
R. Badaoui et al. telephone, and an American Society of Anesthesiologists score of II or III stabilized [16]. Patients were excluded if they had heart disease (history of myocardial infarction, heart rhythm disorder) or OSA syndrome, poorly controlled diabetes, a prisoner, or were thought to be poorly compliant [17].
2.2. Preoperative management The first step was surgical consultation where the indication for bariatric surgery in an ambulatory setting was decided. The second step was to evaluate the feasibility of an ambulatory anesthesia during the preanesthetic consultation. During the preoperative surgical consultation, patients were given a drug prescription for the days after surgery. The prescription was for oral analgesics (acetaminophen, 1 g, QID, and tramadol, 100 mg, TID), an antiemetic (metoclopramide 10 mg, PO, TID) and an anticoagulant (subcutaneous enoxaparin, 40 IU, BID, for 10 days, in accordance with French national guidelines [18]), and a proton pump inhibitor (omeprazole 40 mg, PO, QD). The patient was reminded of the instructions (preparation for the surgery) by a phone call the night before the surgery. On the day of surgery, the patients were prepared by the nurse in the ambulatory surgical unit at 7:15 AM, and the induction of anesthesia began at 8:00 AM.
2. Methods 2.3. Surgical procedure This was a prospective, nonrandomized study of a group of patients undergoing day-case SG from May 2011 through July 2013. The study was part of a local research protocol registered as “Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery (GASTRAMBU)” (ClinicalTrials.gov identifier: NCT01513005). The study was approved by the local investigational review board (Comité de Protection des Personnes Nord Ouest II). During a preoperative consultation, patients were given a study information sheet and a drug prescription for the days after surgery. All patients provided their informed, written consent to participate in the study. The indication for bariatric surgery was confirmed in accordance with French national guidelines and the conclusions of a multidisciplinary obesity staff meeting [15]. All patients attended a surgical as well as a nutritional and dietary consultation and underwent pulmonary, endocrine, and psychological assessments.
2.1. Inclusion and exclusion criteria for ambulatory SG The inclusion criteria were body mass index (BMI) between 35 and 60 kg/m2, the absence of a relevant medical history (cardiovascular and/or pulmonary diseases, no previous history of abdominal surgery), and approval by a multidisciplinary obesity staff meeting [15], being considered a treatment-compliant patient aged between 18 and 60 years living within an hour's drive of a hospital and with an on-site support person available for the night after surgery, access to a
All surgeries were performed by the same surgical team that specialized in bariatric surgery. A laparoscopic SG using the technique described by Dhahri et al [19] using an open celioscopy technique for obese patients [20]. Before deflation of the pneumoperitoneum, the surgeon used a catheter to instill 20 mL of ropivacaine (2 mg/mL) under the left and right diaphragmatic domes. During wound closure, an infiltration of the trocar openings with 20 mL of ropivacaine (7.5 mg/mL) was done. The nasogastric tube was removed at the end of the surgery, and there were no drains left in the abdominal cavity.
2.4. Anesthesia protocol The anesthesia protocol was a specific standardized protocol for ambulatory SG surgery. All patients received treatment with cimetidine (400 mg), and premedication with hydroxyzine (1.5 mg/kg) was done 30 minutes before anesthesia for anxious patients. Compression stockings were put on the patient the night before surgery. In the operating room, pressure points were verified and secured during the positioning, and antibiotic prophylaxis with cefazoline (4 g) was done followed by 5 minutes of preoxygenation at 100% oxygen concentration in a headup position. General anesthesia was induced with propofol (2.5 mg/kg), sufentanil (0.5 μg/kg), and rocuronium (1 mg/kg) to facilitate tracheal intubation. Anesthesia was
Outpatient laparoscopic sleeve gastrectomy: first 100 cases maintained with 4% to 6% desflurane and 0.1 to 0.25 μg kg−1 min−1 remifentanil. The objective of mechanical ventilation was to maintain the arterial oxygen saturation above 95% and the CO2 between 30 and 35 mm Hg with a 50% inhaled oxygen concentration. Standard monitoring included use of an electrocardioscope and pulse oxymeter (SpO2) and measurements of heart rate (HR), end-tidal CO2 (EtCO2), and a noninvasive blood pressure reading. Muscle relaxation was monitored with a TOF Watch, and the depth of anesthesia with BIS. Intraoperative hypothermia was prevented by a warming system (Bair Hugger). Neuromuscular blockade was systematically reversed using sugammadex (4 mg/kg) when TOF was equal or higher than 2, and the patient was extubated in the operating room. Multimodal postoperative analgesia included nefopam (20 mg), tramadol (100 mg), and paracetamol (1 g), started 30 minutes before the end of the surgery, and completed with intravenous morphine titration in the recovery room if the visual analog scale was greater than 30 mm. To prevent postoperative nausea and vomiting (PONV), patients routinely received a treatment with dexamethasone (8 mg) and droperidol (1.25) mg upon the induction of anesthesia, and a treatment with ondansetron (4 mg) during the postoperative period.
2.5. Postoperative management 2.5.1. Day of the surgery After surgery, patients were admitted to the postoperative care unit (PACU). There were no specific procedures for postoperative monitoring in the PACU, and discharge criteria were validated using the ALDRETE score. After surveillance in the PACU, patients were admitted to the surgical unit for an assessment of vital signs (temperature, HR, blood pressure, and oxygen saturation), any postoperative nausea or pain (according to the classification published by Serlin et al [21]), and a blood test for hemoglobin level was done. In all cases, an upper gastrointestinal (UGI) study with an oral contrast medium was used to screen for gastric leaks. In the absence of clinical, biological, or radiological anomalies, oral feeding was resumed and a home discharge was arranged by the surgeon and anesthesiologist. Otherwise, patients were admitted to a conventional surgical unit (overnight admission). Before they were discharged, all patients were taught how to count their HR at home after the surgery and were given dietary advice and a written note informing them of the symptoms that would need an emergency consultation (fever, tachycardia, pain not relieved by prescribed pain medication) and the surgeons's 24/7 telephone number. The patients were checked to see that they had the discharge prescription given preoperatively. 2.5.2. Days after surgery Patients were called the day of the surgery by the surgeon and the day after the surgery by the surgical unit nurse. The
87 patient was asked to report his or her body temperature, HR, and any incident of abdominal pain, nausea, and/or vomiting. Patients were routinely seen in the clinic on postoperative day 4 and underwent a full clinical evaluation and analysis of additional complete blood count and C-reactive protein level. They were seen again at the first postoperative month and 3 months later, when they were queried about their level of satisfaction with day-case SG.
2.6. Study criteria The primary endpoint of the study was the unplanned overnight admission rate. The secondary endpoints were the cause for unplanned overnight admission rate, nausea and pain (graded according to Serlin et al) [21]), complications during the first 4 postoperative days, and levels of patient satisfaction with day-case SG at 3 months.
2.7. Statistical analysis The results were expressed as the mean ± SD and range (for quantitative variables) or as the number and percentage (for qualitative variables).
3. Results 3.1. Population study During the study period, 416 patients underwent primary SG. One hundred patients met all the study criteria and agreed to undergo ambulatory SG (24.0%). All patients who met the inclusion criteria for this type of study agreed to participate. Of the 316 patients not selected for day-case SG and undergoing SG as conventional surgery, 25 (7.9%) had poorly controlled type 2 diabetes mellitus, 95 (30.0%) had OSA, 70 (22.1%) had a BMI 60 kg/m2 or greater, and 126 (39.8%) did not meet the criteria for Day-Case surgery. The group of 100 patients consisted of 93 women and 7 men and had a mean age of 35.9 ± 10 years (22-55 years) and a mean BMI of 42.4 ± 3.3 kg/m2 (37.5-50.8 kg/m2). Two patients had a BMI 50 kg/m2 or greater. In terms of comorbidities, there were 13 cases of hypertension, 6 controlled type 2 diabetes mellitus, 7 with dyslipidemia, and 2 with metabolic syndrome (NCEP ATP3). In view of our exclusion criteria, no cases of OSA were observed. Ninety-eight percent of the patients were classified as American Society of Anesthesiologists score 2 and 3.
3.2. Surgical procedure All procedures were performed laparoscopically. There was no conversion to open surgery. The mean ± SD (range) operating time was 58.7 ± 11.5 minutes (30-105 minutes).
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Twenty-six percent of the patients had surgery lasting more than 1 hour. Concerning intraoperative events, 1 patient required the introduction of an additional trocar (due to difficult exposure), and 6 patients required a suture for arteriolar bleeding on the gastric staple line.
3.3. Anesthesia procedure In 8 patients, peripheral venous access was difficult and required more than 2 attempts. There was no need for a central venous catheter. An Eschmann stylet (Portex) was necessary for tracheal intubation in 6 cases, and intubation was considered as very difficult in 1 case. Orotracheal intubation was difficult in 1 other patient. One patient developed erythema in the absence of hypotension upon anesthetic induction, but this did not affect the surgical procedure.
3.4. Postoperative data 3.4.1. Day of the surgery By comparing pain scores at admission and discharge from the PACU (Figs. 1 & 2), when leaving the operating room, 19% of the patients felt moderate to severe pain. When leaving the PACU, 94% of patients felt no or mild pain. Eighty-two percent of the patients had no PONV, and 7 patients needed treatment using ondasetron. Three patients presented with bronchospasm in PACU that was treated with bronchodilators and inhaled anticholinergics. Three patients presented with moderate hypertension with spontaneous resolution (no treatment was needed), and 1 patient presented an episode of hypotension that was corrected with fluid overload without the need for catecholamines. We noted no metabolic complications and no hypo- or hyperglycemia. Mean stay time in the PACU was of 89 minutes, with lowest and highest values of 35 and 240 minutes. The resumption of oral intake was possible for almost all patients on the same day of the surgery, except for 1 patient who had nausea and for whom food intake was postponed to the next day. Food intake was resumed, on average, 529
Fig. 1
Pain on discharge from the PACU.
Fig. 2
Pain on discharge from the surgical unit.
minutes (465-585 minutes) after hospital admission to the ambulatory surgical unit. Ninety-two patients were able to return home on the same day, with an average hospital stay in the ambulatory surgical unit of 630 ± 37 minutes (575-675 minutes). For 8 patients, the discharge was postponed to the next day. Reasons were discomfort after UGI in 3 cases, pain in 2 cases, nausea in 1 case, somnolence in the day-case unit in 1 case, and difficult intubation during surgery in 1 case. 3.4.2. Days after surgery The night after surgery and on the following day, all patients were contacted by phone. Only 5 patients experienced symptoms: 2 patients had diarrhea, 1 patient had pain unrelieved by prescribed medication, 1 had atypical left chest pain, and 1 had emesis. No unscheduled hospital readmission was necessary between the exit from the surgical unit and the call on the day after surgery. During the first 4 postoperative days, 2 patients had unscheduled consultation and were hospitalized: 1 for chest pain (pneumonia) requiring antibiotic treatment and hospitalization for 2 days, and 1 for abdominal pain secondary to ischemia of the upper pole of the spleen requiring analgesic treatment with morphine for 2 days. At the scheduled consultation at day 4 after surgery, 3 patients were hospitalized for a gastric fistula and underwent reoperation on the same day of the scheduled consultation. In our protocol, the total hospital readmission rate was 7% (n = 7). Causes of hospitalization were as follows: gastric leak in 3 cases, 1 case of gastric stricture, 1 case of pneumonia, 1 case of hematoma needing radiological drainage, and a case of abdominal pain secondary to ischemia of the upper pole of the spleen. There were 7 unexpected consultations (unscheduled consultations) for 6 different patients. Three of the patients requiring unplanned consultations were not hospitalized. The other causes for unexpected (unscheduled) consultations were abdominal pain (1 patient), dysphagia (3 consultations with 2 patients), and poor wound closure (1 patient). Four of these unexpected consultations (4 patients) led to hospitalization. These unscheduled consultations occurred after postoperative day 4. Our overall major complication rate was 5%: 3 for a gastric fistula, 1 postoperative hematoma, and 1 gastric stricture. The satisfaction rate at 3 months after the surgery procedure performed and managed in an ambulatory setting was 93%. The
Outpatient laparoscopic sleeve gastrectomy: first 100 cases 4 dissatisfied patients were those having had a gastric leak or stricture.
4. Discussion Among the 416 patients operated on for bariatric surgery, 100 (24%) patients fulfilled the inclusion criteria, and they all accepted ambulatory management. The failure rate of ambulatory surgeries in other studies on obese patients was 30% [22], unlike our study in which we noted a failure rate of 8%. The main reasons for this failure were discomfort after performing the UGI in 3 cases, pain in 2 cases, nausea in 1 case (after UGI), somnolence in the day-case unit in 1 case, and difficult intubation during surgery in the last case. This rate can be decreased to 4% because 4 patients, almost 50% of our unplanned overnight admissions, occurred after the UGI was performed. All of these 4 patients were free of symptoms before the UGI was done. Furthermore, a recent study has shown that this test does not reliably detect gastric leaks [23]. Our use of routine UGI was performed in accordance with French national guidelines [15], as this exam is only recommended after SG for medicolegal reasons in France. Our patients were selected after a thorough evaluation of their general health condition, their lifestyle, and their motivation. We deliberately chose patients with less risk for postoperative complications based on different studies on surgical care for gastric banding and bypass surgeries where the mean BMI was between 38 and 46 kg/m2. In our study, the mean BMI was 42.4 kg/m2. Our study population was comparable to those in the literature: 93% of the patients were women, no BMI was greater than 60, and none of the patients had pulmonary pathologies, notably OSA. The safety and the quality of the process were improved by patient feedback. Patients were all operated on in the morning so that we could have a longer postoperative monitoring time before discharge. The recovery from bariatric surgery is often complex for obese patients; therefore, patient participation in the care is essential. The success of the ambulatory care depends on the willingness of the patients to assume responsibility for their home care, and on the caregivers to ensure a safe recover for the patient. The anesthesia protocol is standardized and based on expert recommendations [24]. It is well adapted to the pharmacological specificities of obese patients. To avoid drug accumulation and prolonged emergence from anesthesia, it is very important to titrate anesthetic drugs and monitor them during anesthesia. Expert recommendations for deep venous thrombosis prevention in obese patients were recently reviewed. In our series, there were no thromboembolic complications. Our protocol was to adapt the low–molecular weight heparin to the BMI without exceeding 10 000 UI anti-Xa per day; the dose was divided into 2 subcutaneous injections for a duration of 15 days. This pharmacological prevention was associated with the use of elastic compression stockings and early deambulation as noted in many recommendations.
89 Special attention is given to the treatment of postoperative pain and PONV, because if uncontrolled, they could jeopardize the discharge from the ambulatory care unit. To prevent postoperative pain, analgesia was included in the protocol. Unlike the Watkins team who infiltrated trocar incision sites with local anesthetics, we used multimodal analgesia, which was started intraoperatively in addition to trocar incision sites and diaphragmatic dome infiltration. The results proved our protocol to be efficient since 81% of the patients presented with mild or no pain on arrival in the PACU, and this percentage reached 94% on discharge from the PACU. Three percent of the patients had severe pain, which is lower than the 5% rate found in the literature. Many studies show that adequate pain management facilitates recovery [25]. When patients were still in pain, morphine titration in the PACU was used to treat the residual pain quickly and efficiently, with minimal side effects. Because nonsteroidal anti-inflammatory drugs are contraindicated in this type of surgery, tramadol was used despite the fact that it can induce nausea. We used routine PONV prevention in our study population consisting of dexamethasone with droperidol. PONV incidence was efficiently reduced in 82% of the patients discharged from the PACU. Only 18% of the patients, those who needed morphine in the PACU, received additional PONV treatment by ondasetron. Body mass index was not related to a difficult airway, but the neck circumference was. In our series, 6 patients, who had no difficult airway criteria, were intubated using a curved stylet, and 1 patient had traumatic intubation for which it was decided before performing the surgical procedure to admit the patient to conventional hospitalization. In our study, no patient was readmitted on an emergency basis. Symptoms observed on the day after the surgery were vomiting, residual pain, atypical left chest wall pain, and PONV. These incidents were revealed because of the strict monitoring protocol that we established. However, these complications do not undermine the continuation of this program of ambulatory bariatric surgery. A good selection of patients who can be operated on as outpatients requires good cooperation between surgeons and anesthesiologists [26], as well as protocolized care. The advances in surgical and anesthetic techniques are improving and shortening the duration of care. The success of the ambulatory care depends on the willingness of the patients to assume responsibility for their home care, and on an optimized and safe recovery path. But “organization” remains the most important point. Performing SG on an outpatient basis requires cooperation and collaboration between the different persons involved: the surgeon, the anesthesiologist, the nursing team, the family doctor, and the patient. Besides the medical care we provided to the patient throughout our study, we did not neglect the organizational aspect, and we are satisfied with our ambulatory surgical unit because during the study we noticed no incidents relating to the organization of the patient pathway. Theissen et al [26] retrospectively analyzed severe complications arising during outpatient care from the database of one of the largest medical malpractice liability companies engaged
90 legal responsibility, and described a certain number of accidents related to organizational dysfunction (identity verification, wrong intervention or wrong side, failing equipment). These results remind us of the importance of mastering the patient's whole clinical pathway, particularly in the structures that handle important patient flow. Indeed, there is no difference in the surgical technique between inpatient and outpatient surgery; the difference resides in the organization. The results of our work have not identified ambulatory surgery as being associated with high medicolegal risk in France. Nevertheless, risk control (medical and organizational) has to remain a priority for all medical care providers to increase the safety and the quality of care in outpatient surgery. Risk control is, above all, the respect of the recommendations of the different scientific societies. According to the results of our preliminary study and of our first 100 patients [27,28], we continue to offer this type of management for patients undergoing SG.
5. Conclusion The demand for bariatric surgery will undoubtedly continue to grow. The success of SG continues to be widely communicated through the media. This increased demand will lead to performing this surgery on an ambulatory basis. The results of our study demonstrate that SG definitely has its place in an ambulatory setting. This surgical protocol ensures comfort and safety for the patient. Nevertheless, certain conditions must be met to carry out the procedure, beginning with a careful selection of patients, validation of eligibility criteria, a well-adapted hospital structure. Most importantly, a real commitment on the patient's part is needed for the success of such a procedure in an ambulatory setting. On the basis of these results, we continue to offer SG as ambulatory surgery in our center.
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