Perioperative Management of the Bariatric Patient in Italy

by Yigal Leykin, MD, MSc; Tommaso Pellis, MD; Filipo Sanfilippo, MD; Luca Busetto, MD; Marco Anselmino, MD; Claudio di Salvo, MD; Francesca Fortran, MD; and Francesco Giunta, MD

Drs. Leykin, Pellis, and Sanfilippo are from the Department of Anaesthesia and Intensive Care, Santa Maria degli Angeli Hospital, Pordenone, Italy; Dr. Busetto is from the Department of Medicine and Surgical Sciences, University of Padova, Italy; Drs. di Salvo and Foltran are from the Bariatric Surgery Unit, Azienda Ospedaliera Pisana, Pisa, Italy; and Dr. Giunta is from the Division of Anesthesia and Intensive Care, Department of Surgery, University of Pisa, Italy.

Introduction
The incidence of morbid obesity (MO) is steadily increasing in Western countries.1,2 A highly debilitating disease associated with a significant reduction in life expectancy, it is hence considered one of the most important health risks factors in Western countries. The results of long-term, dietary-behavioral therapy are sadly disappointing, with as much as 90 percent of relapses.4,5 Therefore, surgery remains the only effective treatment for patients with MO when other therapeutic strategies have failed.6 The annual number of weight loss operations performed in the US in the early 1990s numbered only 16,000 per year, but increased to greater than 100,000 by 2003.7 A similar trend has been observed in Italy, with significant increase in the number of hospitals where bariatric surgery is performed as well as in the overall number of operations.

Two societies have been constituted in Italy, the Italian Society of Obesity (SIO) and Italian Society of Obesity Surgery (SICOB), that collaborate to determine clinical standards and organize a national conference on a yearly basis.8,9

In 2007, SICOB published specific guidelines for bariatric surgery.10 These guidelines are strictly evidence-based and therefore similar to others published internationally, such as those of the American Society for Metabolic and Bariatric Surgery (ASMBS) Consensus Conference and the Interdisciplinary European Guidelines on Surgery for Severe Obesity (EAES). They are in line with International Federation for the Surgery of Obesity (IFSO) recommendations for centers of excellence, representing a cornerstone on organization and clinical management of bariatric centers in Italy.

STATISTICS
In Italy, 35 percent of the population is overweight with a male prevalence, while 10 percent is obese with a slight female prevalence.10
Epidemiological data published on a sample of the Italian population aged over 18 years examining in the period between 1999 and 2000 demonstrates that morbid obesity (BMI>40) is more frequent in women compared to men (1% vs 0.7%), with a significant prevalence of the disease in the South.3 Since 1994, there has been a 25-percent increase in the obese population in Italy. The last report of the Italian Auxologic Institute (published in 2006) concluded that 16.5 million Italians are overweight and that approximately 5.5 million are obese (BMI between 30 and 40), while 500,000 have a BMI greater than 40.11 In Italy, in contrast with US, it is the youngest population that suffers from this pathologic increase in weight (36%). Based on this trend, it is believed that obesity will increase significantly in the future.12

The economical costs related to obesity are estimated to be approximately about 23 billion euros, 11 billion of which are supported by the National Health System (60% hospitalization, 10% diagnostics, 15% drugs, and 15% the cost of the medical examination).9 According to a recent study, the economic costs of bariatric surgery and postoperative follow-up for five years in the area of Milan (Lombardia region) is 5.553 euros per patient. The population of Lombardia is seven million, and the prevalence of severe obesity is 2.5 percent (175,000 patients). Theoretically, 42,000 of this population could benefit from bariatric surgery; therefore, the total economic cost for this population would be of 233,226,000 eurso. SICOB estimates that currently 1.5 million patients may benefit from bariatric surgery in Italy.9

ACCESS TO CARE
Patients may be referred to a surgeon by centers that specifically treat obesity or/and eating disorders (centers run by psychiatrists, psychologists, and dietitians), by a specialist (such as cardiologists, orthopedists, or endocrinologists), or by the general practitioner.

At present, hospitals performing bariatric surgery in Italy are divided into the following two classes: a) first-level centers that perform at least 40 procedures per year; and b) second-level centers that perform at least 80 procedures a year. The second-level centers act also as teaching hospitals for new centers. Every center is run by a multidisciplinary team, which includes the bariatric surgeon, nutritionist/dietitian, psychiatrist/psychologist, anesthesiologist, cardiologist, pneumologist, and plastic surgeon.

Since a multidisciplinary approach requires coalescing practitioners who specialize in obesity from a broad range of perspectives, final treatment and outcomes stem from an intensive collaboration among a number of specialists, most frequently coordinated by the endocrinologist. This network includes units such as metabolic disease and diabetology, respiratory physiopathology, cardiovascular disease, internal medicine, psychiatry, general surgery, plastic surgery, and anesthesia and intensive care. The aforementioned specialists must synergize their expertise in order to design the best approach for each patient.

Usually, the very first step the obese patient undergoes within the center is an endocrinologic exam, the aim of which is to identify the metabolic profile of each subject and to exclude any secondary cause of obesity, such as Cushing’s disease or thyroid disorders. Other clinical examinations, such as ones conducted by cardiologists and pneumologists, aim at evaluating and treating cardiovascular and pulmonary comorbidities. The subsequent interviews with dietitians, psychologists, and psychiatrists contribute to better understanding a patient’s clinical and psychological features.

Patient selection depends on psychological, medical, and surgical criteria.

GENERAL INDICATIONS FOR BARIATRIC SURGERY
The criteria adopted by the SICOB for adults between the ages of 18 and 60 are similar to the United States National Institutes of Health Consensus Development Conference Panel recommendation for the selection of adult obese patients:13
• Patients with a BMI greater than 40
• Patients with a BMI between 35 and 40 and diseases associated with high risk for life, such as obstructive sleep apnea, arterial hypertension, latent heart failure, diabetes mellitus type II, serious dyslipidemia, debilitating osteoarthritis (or need of weight loss for orthopedic surgery), or serious psychological problems caused by obesity.
Since 2005, in Italy it is possible (only within very particular conditions) to consider surgery for patients with a BMI between 30 and 35 presenting with severe comorbidities that can benefit from surgical treatment.14
The maximum limit of age is 60 years, but this limit refers to the biologic rather than chronologic age. At least a few serious failed weight loss attempts with non-surgical methods are recommended as a criterion for WLS. In addition, severe obesity must date back more than five years.
In patients under 18 years of age, a surgical solution can be adopted if BMI is greater than 40 and one severe comorbidity is present, or if BMI is greater than 50 and there is only one minor comorbidity.

CONTRAINDICATIONS
The contraindications to bariatric surgery adopted by the SICOB are in line with the following international standards:
• Absence of documented period of medical treatment
• Inability to participate in a prolonged follow-up program
• Major psychiatric diseases (such as those that will inhibit cooperation and postoperative controls)
• Alcoholism or drug addiction
• Short life expectancy
• Patients who are unable to take care of themselves and without family or social services support.

PREOPERATIVE EVALUATION AND WORKUP
Patients scheduled for bariatric surgery undergo preoperative anesthesiological and surgical assessments between 1 and 3 months before surgery takes place. In some centers, blood tests, chest X-rays, pulmonary function tests, and cardiological evaluations are requested by the anesthesiologist in order to define the anesthesiological risk and to plan an individualized intraoperative and postoperative strategy. In other centers, the basic evaluation is similar to that of patients admitted for major abdominal surgery and only in case of specific comorbidities supplemental tests are requested. Medical comorbidities must be recognized and, when possible, therapy optimized before elective bariatric surgery.

The preoperative surgical assessment aims to identify the more appropriate operation and again to rule out possible comorbidities that may constitute a contraindication for surgery; radiological and endoscopic evaluations of gastrointestinal tract are routinely performed.

Preoperative interviews with dietitians, psychologists, and psychiatrists are intended to prepare the patients for postoperative changes in their lifestyles and habits and to obtain their compliance for long-term follow-up programs.9

There is general agreement on the need for thromboembolic prophylaxis, but there are not yet specific, nationwide, uniform protocols for weight loss surgery; every center follows its own policy, while antibiotic prophylaxis follows protocols used for the major abdominal surgery.9

INFORMED CONSENT
The Consensus Conference of the SICOB produced a detailed informed consent document. The document is 30 pages in length and includes comprehensive written and illustrative perioperative information, as well as a specific questionnaire to be completed by patients to attest their understanding of the informative document content, and finally the legal consensus for surgical and anesthesiological procedures, to be signed by the patient.

Unfortunately, although approved, the SICOB informed consent is not yet in use; at the present time, every center relies on its own informed consent. However, those informed consents that centers currently use do meet the main criteria mentioned within the SICOB
document.9

SURGERY
A number of different types of weight loss surgical procedures have been developed over the years. In Italy, centers for bariatric surgery offer both restrictive procedures, reducing the stomach volume, and combined procedures, shortening the digestive tract and reducing the stomach capacity. For all operations, laparoscopy is the first choice approach. The most frequently performed operation in Italy is laparoscopic adjustable gastric banding (LAGB), but in the last few years there has also been a significant increase in Roux-en-Y laparoscopic gastric bypass (LRYGB).14 While presently in Italy there is consensus regarding the indications and contraindications to bariatric surgery, there is a lack of agreement on the indications for a specific surgical approach, and the choice is often based on the clinical judgment and experience of the surgeon.9

The mean duration of the procedure is 30 to 80 minutes for LAGB, 100 to 150 minutes for sleeve gastrectomy, and 150 to 250 minutes for LRYGB.9,15

ANESTHESIOLOGICAL ASPECTS
As for surgical procedures, there is a lack of specific recommendations regarding the anesthesiologic approach to morbidly obese patients. However, anesthesiologic techniques adopted are generally in line with the recent international literature.16,17

The day before surgery, stress ulcer prophylaxis is started, along with overnight hydration. The day of surgery, low molecular weight heparin is administered as a standard of care for thrombosis prophylaxis.

During surgery, general anesthesia is performed. Standard monitoring (ECG, noninvasive blood pressure, pulse oximetry, end-tidal capnography, urine output, and temperature) is routinely adopted. An arterial line is often used for continuous blood pressure monitoring and arterial blood gas sampling. The depth of anesthesia is also monitored by bispectral analysis in several centers. Finally, for select patients with severe comorbidities, a few centers perform intraoperative transesophageal echocardiography.

The most commonly adopted induction technique is propofol with opioid, but other commonly used drugs include midazolam, thiopental and, occasionally, ketamine.

For most patients, a rapid intravenous (IV) induction with propofol and succinylcoline, combined with cricoid pressure, is the best means of rapidly securing the airway.

The most widely adopted muscle relaxants are cisatracurium and rocuronium. Anesthesia is maintained mostly with an IV infusion of propofol and a short acting opioid (remifentanil) or, in spite of propofol, with an inhalational anesthetic (sevoflurane or desflurane). Nitrous oxide is usually not used. The CO2 pneumoperitoneum is maintained between 12 and 14cm H2O.

Extubation is recommended in fully awake patients with a train-of-four ratio of 0.9 and in 30° reverse Trendelenburg position. However, not all centers routinely assess neuromuscular blockade. Regional anesthesia and analgesia in morbidly obese patients is not popular in Italy.

POSTOPERATIVE MANAGEMENT
The SICOB national data indicate that the rate of early surgical postoperative complications after LAGB is 1.9 percent and 14.2 percent after LRYGB. It is evident that the complexity of the operation increases the incidence of complications.9

The literature provides little guidance for post-anesthesia care intervention to improve outcomes in morbidly obese patients, including those with diagnosis of sleep apnea.16 Italy is no exception, with very little concrete direction provided on this topic. In some centers the patients are admitted for the first 24 postoperative hours to the intensive care unit (ICU), while in others they are admitted for several hours into the post anesthesia care unit (PACU) or even in the surgical department (with all the necessary monitoring). If there are complications in PACU or in the surgical department than the patient is transferred to the ICU.

Mechanical ventilation is rarely needed in the postoperative period. Continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) are rarely used, in order to prevent the possibility of the massive gaseous distension in bypassed stomach that can lead to staple disruption and leak.

Postoperative analgesia is also not uniform. Some surgeons infiltrate the trocar sites during the procedure with local anesthetics. In most centers, the use of nonopioid analgesics is instituted early and in some, IV opioid patient-controlled analgesia (PCA) is used. In others, continuous IV infusion for the first 24 to 48 postoperative hours with nonsteroidal anti-inflammatory drugs is sometimes associated with minor opioids.

In Italy, an epidural catheter for postoperative analgesia is rarely positioned, both due to the technical difficulties and relatively mild invasiveness of the laparoscopic approach.

LONG-TERM FOLLOW-UP
SICOB national data indicate that the rate of late surgical postoperative complications after LAGB is 10.3 percent (6.8%=major complications) and 2.9 percent after LRYGB. The rate of reoperations after LAGB is 7.6 percent and after LRYGB is 3.3 percent. All SICOB data include the learning curve phase; therefore, probably in the future the rate of surgical complications as well as reoperations will decrease.9

Educating bariatric surgical patients on nutritional therapy begins early in the assessment process. An in-hospital registered dietitian experienced in bariatric surgical counseling meets with the patient regularly to discuss specific nutritional guidelines and review post-discharge dietary progression, as outlined in printed patient education materials.

After surgery, a rigorous follow-up program is scheduled. Appropriate suggestions for proper nutrition and specific warnings according to the type of intervention are given. A program of follow-up that provides evaluations at 3, 6, 12, 18, and 24 months for the first two years has been also launched. Thereafter, follow-up is annual. Each patient’s information is recorded in a database that allows the center to print a report at each appointment. In addition, upon request, the patient is enrolled in a psychological support program (group or individual) and access to dietetic support services. Commitment by surgeons to long-term follow-up of all bariatric patients is deeply endorsed by SICOB guidelines, and several long-term series with very high follow-up rates have been published by the leading Italian bariatric centers.18-20

Postoperative quality of life assessment is frequently performed with the aid of the BAROS questionnaire.9

Recently, different rehabilitation centers for morbidly obese patients that offer nutritional, medical, psychological, and physical supports were instituted and are open also to post-surgical bariatric patients.

CONCLUSIONS
As in the US, in Italy we have observed a significant increase in weight reduction surgery. Laparoscopy is now the preferred bariatric surgical approach. While the perioperative management of bariatric patients is in agreement with the recent international literature, we still need to define national guidelines. It is necessary also to better define, in accordance with the National Institutes of Health, minimum standards of bariatric centers and methods of reimbursement. Future multicenter studies may contribute to uniform bariatric surgery patient treatment in Italy.

References
1. National Center for Health Statistics. NHANES III reference manuals and reports. Hyattsville (MD): US Department of Health and Human Services, 1996.
2. Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: Public Health Services, 1996.
3. Istituto Auxologico Italiano: 2° rapporto sull’obesità in Italia. Franco Angeli Editore, milano 2000.
4. Wadden TA. Treatment of obesity by moderate and severe caloric restriction. Results of clinical research trials. Ann Intern Med. 1993;119;688–693.
5. Miller WC, Koceja DM, Hamilton EJ. A meta-analysis of the past 25 years of weight loss research using diet, exercise, or diet plus exercise intervention. Int J Obes Relat Metab Disord. 1997;21(10)941–947.
6. Brolin RE. Update: NIH consensus conference. Gastrointestinal surgery for severe obesity. Nutrition. 1996;12(6):403–404.
7. Steinbrook R. Surgery for severe obesity. N Engl J Med. 2004;350(11):1075–1079.
8. Società Italiana dell’Obesità. Available at
www.sio-obesità.org.
9. SICOB. Lineeguida e stato dell’arte della chirurgia bariatrica e metabolica in Italia. 2008. Available at www.sicob.org.
10. Istituto Auxologico Italiano: 6° Rapporto sull’Obesità in Italai. Franco Angeli Editore, Milano, 2006.
11. Lobstein T, Frelut ML. Prevalence of overweight among children in Europe. Obesity Reviews. 2003;4(4):195–200.
12. Gastrointestinal Surgery for Severe Obesity. 1991 NIH Consensus Statement Mar 25–27;9(1);1–20.
13. Gardinazzi A, Toppino M, Campanile F, et al. Italian group for Lap-Band System: results of multicenter study on patients with BMI<35kg/m2. Obes Surg. 2004;14:415–418.
14. Angrisani L, Lorenzo M, Borrelli V. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric by pass: 5 year results of prospective randomized trials. Surg Obes Relat Dis. 2007;3:127–133.
15. Leykin Y, Pellis T, Del Mestro E, et al. Perioperative mangement of 195 consecutive bariatric patients. Eur J Anaesthesiol. 2008;25(2):168–170.
16. Schumann R, Jones SB, Ortiz VE, et al. Best practice recommendations for anesthetic perioperative care and pain management in weight loss surgery. Obes Res. 2005;13(2):254–266.
17. Leykin Y, Pellis T, Del Mestro E, et al. Anesthetic management of morbidly obese and super-morbidly obese patients undergoing bariatric operations: hospital course and outcome. Obes Surg. 2006;16(12):1563–1569.
18. Favretti F, Segato G, Ashton D, et al. Laparoscopic adjustable gastric banding in 1,791 consecutive obese patients: 12-year results. Obes Surg. 2007;17:168–175.
19. Scopinaro N, Adami GF, Marinari GM, et al. Biliopancreatic diversion. World J Surg. 1998;22:936–946.
20. Gardinazzi A, Toppino M, Campanile F, et al. Italian Collaborative Study Group for Lap Band: predictive value of initial body mass index for weight loss after years of follow-up. Surg Endosc. 2004;18:1524–1527.

Category: International Perspective, Past Articles