OBES SURG (2011) 21:1887–1893 DOI 10.1007/s11695-011-0481-3 CLINICAL RESEARCH Getting the Most from the Sleeve: The Importance of Post-Operative Follow-up Dean Keren & Ibrahim Matter & Tova Rainis & Alexandra Lavy Published online: 30 July 2011 # Springer Science+Business Media, LLC 2011 Abstract Background Bariatric approach to obesity provides substantial weight loss and comorbidity resolution. Our unique service includes pre- and postoperative visits to the Health and Nutrition Clinic headed by a specialist in gastroenterology and nutrition. We compared patients attending regular clinic routine with those who were lost to follow-up with regard to anthropometry, comorbidity, quality of life, and food tolerance and determined who benefited most from the operation. Methods A retrospective review was performed on patients 30 months after undergoing sleeve gastrectomy. Body mass index was used to report weight loss. Bariatric Analysis and Reporting Outcome System (BAROS) and Food Tolerance Score were (FTS) completed by all patients at the 30-month follow-up visit and compared between two groups (group I— 30 months of active postoperative follow-up; group II— without). Results A total of 119 patients participated in the study. For groups I and II, the mean percentage of excess BMI loss at 30 months was 82.08±9.83 and 74.88±8.75, respectively, with better comorbidity improvement in group I. BAROS scores were 7.62±0.72 and 6.92±0.92. FTS was 24.30± 2.09 and 22.55±2.27, respectively. Conclusions From our experience, getting the most from the sleeve is attributed to two main factors: surgery and nutrition. Surgery results in optimal restriction and imD. Keren : I. Matter : T. Rainis : A. Lavy Bnai-Zion Medical Center, Technion Institute of Technology, Haifa, Israel D. Keren (*) Gastroenterology Unit, Health and Nutrition Clinic, Bnai-Zion Medical Center, 47 Golomb Ave, POB 4840, Haifa 31048, Israel e-mail: Dean.keren@b-zion.org.il proved satiety, whereas nutrition relies on a professional medical team providing constant, ongoing patient support throughout all the bariatric process stages. These teams of surgeons and gastroenterologists specializing in nutrition, working side by side, each in their area of specialty, are the main pillars leading to the success of the sleeve. Keywords Sleeve gastrectomy . Nutrition . Morbid obesity . Mid-term results . Bariatric surgery . Quality of life . Food tolerance Obesity is a major cause of premature death, and its prevalence is only increasing worldwide [1]. Its predisposition to many comorbid diseases that affect nearly every part of the body [2]. The present population has a decreased life expectancy and increasing body mass index (BMI) results in a proportionally shorter lifespan [3, 4]. Despite these known factors, nonoperative management with diet, exercise, behavior modification, and medications rarely achieves adequate durable weight loss [5, 6]. Bariatric surgery is associated with long-term weight loss and profound effects in all obesity-related comorbidities [7, 8]. Laparoscopic sleeve gastrectomy (LSG) has been in use in approximately the past 7 years. Data emerging from studies demonstrate that LSG provides substantial weight loss and resolution of comorbidities at 3–5 years of followup [9]. It has been proved to exhibit multiple advantages compared with other bariatric procedures. The lack of a foreign body, preservation of the pylorus and the antrum, avoidance of the dumping syndrome, non-alteration of the absorption of orally administered drugs, short postoperative hospitalization, and relatively easy laparoscopic procedure are some of the advantages. The efficacy of this operation has been attributed to the reduction of the gastric capacity (restrictive effect) 1888 and/or to gastrointestinal hormones modification (hormonal effect) [10, 11]. The benefits include a low rate of complications, maintenance of gastrointestinal continuity, and no malabsorption. The bariatric service provided by us includes unique preoperative and postoperative visits to the Health and Nutrition Clinic. This clinic is headed by a physician with specialization in gastroenterology, nutrition, and internal medicine. This combination of medical specialties is the most appropriate for obese patients with co-morbidities undergoing surgery in the gastrointestinal system and requiring intensive nutritional guidance and follow-up beginning from the visits before the operation to years afterward. All patients looking into bariatric surgery are seen primarily in this clinic and thoroughly evaluated nutritionally as well as medically. Patients wishing to undergo surgery are advised accordingly as to which surgery is most suitable for them after joint consultations with the surgeons. At the end of the process, which includes a number of visits, patients are ready for surgery and referred to the surgery clinic. During their stay in the hospital, regular visits are made by the clinic staff and upon their release, they are prepared for the future. After surgery, the patients were encouraged to return for medical follow-up visits at 4, 8, and 12 weeks; then, at 6, 9, and 12 months; and, finally, biannually. All patients who are a part of this clinic have round-the-clock medical/nutritional support to all questions and the problems that may occur. All the patients who underwent surgery at our center, including those without active participation in the clinic follow-up, were invited for a 30-month post-operative visit. To our dismay, despite our encouragement, not all patients returned for follow-up visits. The purpose of this study is to report our experience and to help determine which group of patients, those who actively participate in the clinic routine compared with those who are lost to follow-up, exhibit the best results with regard to anthropometric measurements, quality of life (QoL) using the updated Bariatric Analysis and Reporting Outcome System (BAROS) and Food Tolerance Score (FTS) and, therefore, benefit the most from the operation for years to come [12]. Methods A retrospective chart review was completed on all patients who had undergone LSG between January 2007 and December 2008. The protocol was approved by the Institutional Review Board of the Bnai-Zion Medical Center. All patients met the 1991 National Institutes of Health Consensus Conference guidelines for bariatric surgery with a BMI of ≥ 40 kg/m2 or a BMI≥35 kg/m2 OBES SURG (2011) 21:1887–1893 with associated co-morbidities. The study included two groups: (1) group I those actively participating in the Health and Nutrition Clinic follow-up visits, and (2) group II patients who did not participate in the regular clinic followup visits, but returned for the 30-month follow-up visit. All patients went through the same routine pre-bariatric examinations: blood tests, chest radiography, upper gastrointestinal series or endoscopy, electrocardiogram, abdominal ultrasound, and endocrinologic evaluation. Due to the specialty of the clinic, a complete nutritional evaluation followed by consultation was performed on all patients, with the belief that one of the factors leading to the success of the sleeve and all bariatric procedures is the implementation of a healthy diet on the new stomach, and implementation is better when patients are prepared. On their release from the surgery ward, the patients received detailed medical and nutritional instructions on how to behave nutritionally and how to prepare themselves for life with their “new stomachs.” During hospitalization and even after the patients’ release, the staff remains in close contact with all the patients who have been operated at our center. The support is 24/7 (24 h a day/7 days a week)—in web forums, Internet groups, phone and mail support, and regular clinic visits. The surgical technique utilized a 39 French calibration bougie placed trans-orally along the lesser curvature of the stomach and a stapled vertical gastrectomy performed parallel to this, starting at a minimum distance of 5 cm from the pylorus and leaving a sleeve volume of about 50 cc. Staple-line reinforcement was performed by a running suture to prevent bleeding and leakage. The BMI was used to report weight loss, usually a relative parameter of the percentage of excess BMI loss (% EBMIL) comparing values before and after the operation. A BMI of 25 kg/m2 was the lowest limit of overweight. Therefore, the calculation of the percentage of excess BMI lost was done with the help of the following formula: [(operative BMI—follow-up BMI)/(operative BMI— 25)]×100 [13]. The use of this relative parameter is superior, because it is more descriptive and allows for objective comparisons among series. The QoL was measured with the updated BAROS questionnaires, which were completed by all patients during the 30-month post-operative clinic visit. It included the analysis of weight loss, improvements in obesity comorbidities, and changes in QOL. This scoring system analyzes the three domains just mentioned, granting each of them three points. The occurrence of complications and reoperations deducts points. The final score classifies the results into five outcome groups, from failure to excellent, establishing an objective definition of success (failure < 1; fair > 1–3; good > 3–5; very good > 5–7; and excellent > 7–9). OBES SURG (2011) 21:1887–1893 1889 The FTS developed by Suter et al. was determined and compared between both groups [14]. The FTS was calculated based on a one-page questionnaire. The onepage questionnaire was divided in four parts: (1) an overall assessment of the patient’s satisfaction about the quality of his/her alimentation, (2) questions about the timing of meals and food intake between meals, (3) an evaluation of tolerance of eight different types of food, and (4) an evaluation of the frequency of vomiting/regurgitation. A score is derived from parts 1, 3, and 4 of the questionnaire. The patient’s satisfaction about food intake is given between one (very poor) and five (excellent) points. Food tolerance is given between 0 and 16 points: for each specific type of food, two points if the patient can eat this type without any particular difficulty, one point if he/she can eat it with some difficulties/restrictions, and zero points if he/she cannot eat it at all. The importance of vomiting/ regurgitation is given between zero and six points: daily vomiting or regurgitation—zero points, three or more times a week—two points, up to twice a week—four points, and never—six points. The score can, therefore, vary between 1 and 27, 27 being the maximum for an excellent food tolerance. Postoperative Care Patients were kept on liquids for 3 days, and then they were advanced to pureed food for the next 2 weeks. At first, the foods were watery and with time, they got to be thicker. Subsequently, the diet was advanced to solid soft food. All progressions in food substances, and any other complaint or question to arise, were made with the medical nutritional team giving on-call guidance to patients at all times. Patients were encouraged to have high protein intakes. Owing to the drastic change in the diet (quality and quantity), we postoperatively prescribe oral multivitamin supplementation, at least temporarily, for all patients. Table 1 Baseline Patient Characteristics Proton pump inhibitors were used in all patients for the first month postoperatively and then as needed. Statistical Analysis Results are expressed as mean ± standard error of the mean. Statistical evaluation was performed by a t-test. The independent two-sample t-test was used for comparison of statistical significance, which was set at a p value of <0.05. Results A total of 119 patients were eligible to participate in the study. By December 2010, all patients included in the study who had completed the BAROS and FTS questionnaires returned. Group I had 83 patients: 54 women and 29 men aged 40.37±9.74 and a mean pre-operation BMI of 44.48± 6.94. Group II had 36 patients: 21 women and 15 men aged 39.30±11.27 with a pre-operation BMI of 44.75±5.46. The baseline demographic data of the study population are listed in Table 1. All patients from group I actively participated in the clinic follow-up routine with a 100% adherence rate. Weight loss as described in Table 2 shows a significant decrease of BMI observed in most patients at the 30-month follow-up. The%EBMIL at 30 months was 82.08±9.83 in group I and 74.88±8.75 in group II (P<0.001). The BAROS scores for QoL (Table 2) were 7.62±0.72 for group I and 6.92±0.92 for group II (P<0.001). The three parts of the analysis include section I: weight loss; II: medical conditions, and III—the Moorehead–Ardelt Quality of Life Questionnaire (M-A QoLQ). M-A QoLQ scores ware given for five questions and graded from -0.5 to +0.5 (increasing by 0.1, without 0). Upon analyzing this part of the questionnaire (Table 3), there was a significant difference between both groups with regard to the two Clinic follow up (n=83) No clinic follow-up (n=36) Range The P values for between-group comparisons were not significant Age Sex (f/m) Body Mass Index Pre-operation Type II diabetes mellitus Hypertension Hyperlipidemia Obstructive sleep apnea Joint pain Gastroesophageal reflux disease Polycystic ovaries (female) 40.37±9.74 54/29 44.48±6.94 44 (53.01%) 35 (42.16%) 41 (49.39%) 14 (16.86%) 55 (66.26%) 37 (44.57%) 5 (6.02%) 19–59 35–59 Range 39.30±11.27 21/15 44.75±5.46 20 (55.5%) 15 (41.66%) 18 (50%) 7 (19.44%) 24 (66.66%) 15 (41.66%) 2 (5.55%) 19–60 35–61 1890 OBES SURG (2011) 21:1887–1893 Table 2 Results after 30 months %EBMIL %EWL BAROS FTS Clinic follow-up No clinic follow-up P value 82.08±9.83 80.01±8.21 7.62±0.72 24.30±2.09 74.88±8.75 72.53±7.34 6.92±0.92 22.55±2.27 P<0.001 P<0.001 P<0.001 P<0.001 %EBMIL—excess Body Mass Index Loss %EWL—excess Weight Loss BAROS—Bariatric Analysis and Reporting Outcome System FTS—Food Tolerance Score aspects: (1) “Usually I feel” (0.34±0.12 vs. 0.27±0.11; P= 0.0028) and (2) “The way I approach food” (0.34±0.12 vs. 0.24±0.17; P=0.0012). However, the other areas, such as assessing physical activities, social contacts, ability to work, and pleasure from sex, were not significantly different between both groups. The FTS scores behaved in the same manner of significance: 24.30±2.09 for group I and 22.55±2.27 for group II (P<0.001). An analysis of the evaluation of tolerance of eight different types of food from the FTS (Table 4) showed a significant difference between both groups when eating red meat (P=0.0014), white meat (P= 0.0482), salad (P=0.0063), and rice (P=0.0226). The other types of food, such as vegetables (including cooked and soft), bread, pasta, and fish, were of no statistical difference. Effect on Comorbidities There was a significant improvement in obesity-related comorbidities after LSG (Table 5). Over 40% of patients in this series had type 2 diabetes, hypertension, or hyperlipidemia. There was complete remission (normal glucose levels with no medications) or improvement (reduction in medication) in 93.18% of patients with diabetes in group I and in 85% of patients in group II after 30 months. In fact, 85.71% of patients with hypertension from group I and 73.33% of patients from group II were rendered normotensive or as receiving a reduced dose of medication. Overall, 78.04% of patients from group I and 72.22% of patients from group II had reduced or stopped on hypolipidemic medications. Less patients suffered from obstructive sleep apnea (OSA): 14 (16.86%) from group I and 7 (19.44%) from group II. The OSA group showed at least an improvement in 13 (92.85%) and 6 (85.71%) in group II. Totally, 55 (66.26%) patients from group I and 24 (66.66%) patients from group II suffered from joint pain. After 30 months, 33 patients from group I (89.18%) and 11 patients (73.33%) from group II had either no or much lesser complaints. Gastroesophageal reflux disease affected 37 (44.57%) patients from group I and 15 (41.66%) patients from group II. At the 30-month follow-up, there was a decrease or cessation of medications or complaints in 33 (89.18%) and 11 (73.33%) patients from groups I and II, respectively. Discussion The projections of World Health Organization (WHO) indicated that globally in 2005 approximately 1.6 billion adults (age 15 +) were overweight, and at least 400 million adults were obese. The prevalence of obesity is predicted to increase in the future and with it the number of patients undergoing minimal invasive techniques to achieve durable weight loss is also expected to increase. The WHO has projected that by 2015, more than 700 million adults will be obese [15]. A systematic review of the long-term effects of obesity treatments on body weight, risk factors for disease, and disease found that weight loss from surgical and nonsurgical interventions for people suffering from obesity was associated with a decreased risk of development of diabetes and a reduction in LDL cholesterol, total cholesterol, and blood pressure in the long term [16]. Our unique preoperative workup included at least two appointments at the Health and Nutrition Clinic in our medical center. The appointments included a discussion regarding the nature, risks, side effects, complications, and limitations of various bariatric procedures. We feel that it is imperative that obese patients are made aware of the potential adverse effects of weight loss so that they Table 3 The Moorehead–Ardelt Quality of Life Questionnaire (M-A QoLQ)—self asteem and activity levels Question Answer scale from -0.5→+0.5 Clinic follow-up No clinic follow-up P Usually I feel I enjoy physical activities I have satisfactory social contacts I am able to work The pleasure I get out of sex The way I approach food Very bad → very good about myself Not at all → very much None → very much Not at all → very much Not at all→ very much I live to eat → I eat to live 0.34±0.12 0.33±0.12 0.30±0.15 0.32±0.14 0.31±0.13 0.34±0.12 0.27±0.11 0.30±0.12 0.31±0.12 0.30±0.12 029±0.12 0.24±0.17 0.0028 0.2303 0.5618 0.4182 0.5177 0.0012 OBES SURG (2011) 21:1887–1893 1891 Table 4 Evaluation of tolerance of eight different types of food from FTC answer to the question: more specifically, how can you eat? Red meat White meat Salad Veggies Bread Rice Pasta Fish Clinic Follow-up No Clinic Follow-up P 1.10±0.73 0.98±0.76 1.67±0.58 1.44±0.64 1.56±0.49 1.66±0.47 1.61±0.48 1.61±0.48 0.63±0.68 0.69±0.66 1.33±0.67 1.22±0.63 1.58±0.55 1.41±0.64 1.52±0.55 1.47±0.55 0.0014 0.0482 0.0063 0.0852 0.8686 0.0226 0.3977 0.1663 2 easily, 1 with some difficulties, 0 not at all understand the risks as well as the benefits of the approaches to weight loss procedure that they are considering [17, 18]. We discuss with them not only the adverse effects associated with the various pharmaceutical and surgical interventions for achieving weight loss but also those effects that are associated with the different dietary regimens. Studies have shown that patients undergoing the bariatric procedure report various difficulties during the whole process and motivation/self-control/will power, such that clinicians focusing on any single element lead to the exclusion of others and this will not meet the stated needs of a significant portion of their obese patients [19]. This reinforces our current approach that clinicians should offer a comprehensive approach to obesity treatment, and each clinician should focus on the issue with which they are most comfortable and experienced. The final clinician’s recommendations regarding what bariatric procedure should be performed are done after joint meetings with the surgeons. Both groups were similar in baseline demographic data. When examining both groups of patients, the group that actively participated in the clinic routine exhibited a more significant decrease in BMI loss. We preferred the use of %EBMIL to report weight loss. Previous studies recommended the use of %EBMIL = [initial BMI-final BMI)/ (initial BMI–25)×100] as a more objective method to present weight loss results in clinical studies of bariatric surgery [20]. A BMI of 25 was declared by the National Institute of Health as the cutoff point to define overweight and also as the end point for obese patients after bariatric surgery [21]. We prefer the %EBMIL because the excess weight loss (%EWL) does not take the patient’s height into calculation. Height is very important to calculate the ideal body weight (IBW), but height is not really taken into account to calculate the %EWL [%EWL = (initial weight–final weight)/(initial weight–IBW)×100] [13, 22]. Reporting weight loss with %EWL is still popular in the literature; but in our view, the fact that it does not use the patient’s actual height does not make it a valid method. On the contrary, the%EBMIL compares BMI (height and weight) instead of weight only, and this is the reason behind BMI and %EBMIL being recommended as the best parameters for weight loss report [23, 24]. The QoL improved dramatically in both groups, but with a significant difference between them. According to the BAROS score, which summarizes weight loss, correction of comorbidities, improvement of QoL, and complications, at the 30-month follow-up point, an “excellent” score (7.61 ±0.72) could be observed in group I, and a “very good” score (6.92±0.92) in group II. This compares favorably with most other bariatric procedures. We believe that this difference will increase in the future, and patients in group II will be more disappointed with the sleeve results. The two items on the M-A QoLQ indicating that there was a significant difference between the two groups were as follows: “Usually I feel” and “The way I approach food.” This emphasizes that people from group I who were on our constant medical–nutritional support were more able to enjoy eating, felt better, and benefited the most from the operation and weight loss. This further supports our preoperative clinic visits that are aimed at making the Table 5 Effect of laparoscopic sleeve gastrectomy on comorbidities at 30 months in both groups Clinic follow-up Type II diabetes mellitus Hypertension Hyperlipidemia Obstructive sleep apnea Joint pain Gastroesophageal reflux disease Polycystic ovaries 44 (53.01%) 35 (42.16%) 41 (49.39%) 14 (16.86%) 55 (66.26%) 37 (44.57%) 5 (6.02%) No clinic follow-up Remission Improved % change 34 21 28 10 45 29 7 9 4 3 5 4 93.18 85.71 78.04 92.85 90.90 89.18 20 (55.5%) 15 (41.66%) 18 (50%) 7 (19.44%) 24 (66.66%) 15 (41.66%) 2 (5.55%) Remission Improved % change 15 9 10 5 17 9 2 2 3 1 3 2 85 73.33 72.22 85.71 83.33 73.33 1892 patients completely understand this attainable opportunity that is necessary to lead a better life. Regarding resolution of comorbidities, we found very good results in diabetes clinical remission or improvement in both groups (93.18% in group I and 85% in group II). As with the BMI, the percentage of comorbidity remission or improvement was more for group I. Improvement and/or complete remission in comorbidities of obesity, such as hypertension and diabetes mellitus, has been reported to occur in the majority of patients and is in direct correlation with the %EBMIL [25, 26]. The influence on comorbidity is the most important endpoint in bariatric studies [27]. In our series, the FTS was evaluated for all 119 patients after LSG and compared between both groups. The mean FTS was significantly higher for the group that was maintaining regular clinic visits. In our study population, the most significant difference in food tolerance was with regard to red and white meats, salads, and rice. This was as opposed to fish, pasta, bread, and vegetables (also cooked), which are more easily digested. This is in concordance with previous reports that patients reported good alimentary comfort, and mainly red meat was poorly tolerated by some patients, as also reported by Sánchez-Santos et al. [28]. This supports our step-by-step guidance to all patients undergoing the bariatric process, each one proceeding at their own pace to the changes in food texture. The advantage of LSG is not without physiologic basis. It is known that obese patients have increased gastric volumes with a positive correlation to the increase in BMI [29]. From all bariatric procedures, as nutrition specialists, we prefer the sleeve gastrectomy, which divides the stomach vertically to reduce its size to about 25%. The LSG is a pyloric valve-preserving, stomach-reducing procedure and without loss of function. There is significant appetite suppression by removing the gastric fundus, the ghrelin-producing portion of the stomach [30, 31]. Its function remains unaltered; digestion is, therefore, unaltered and the degree of malabsorption is minimized. This leads to only rare and no significant nutritional deficiencies that can occur in morbidly obese patients undergoing LSG [32]. These facts permit us to implement healthy diets according to the food pyramid on the new reduced stomach. Our unique clinic emphasizes the importance of followup and constant online contact as one of the main factors leading to the success of the sleeve. The International Federation for the Surgery of Obesity and Metabolic Disorders published guidelines for safety, quality, and excellence in bariatric surgery [33]. It stated that along with the surgical issues, the centers of excellence of a bariatric institution should provide a lifetime follow-up for the majority of all the patients undergoing bariatric surgery. A recent paper addressing the issues of health behavior, food tolerance, and satisfaction after laparoscopic sleeve OBES SURG (2011) 21:1887–1893 gastrectomy underlines the importance of long-term maintenance programs [34]. We take this one step further in providing round-the-clock support to whatever issue might arise. If patients do not have this appropriate round-the-clock professional support, then the sleeve and its success are at risk. The 100% adherence rate of the patients who chose to actively participate in all the clinic routine (group I) emphasizes this issue. In conclusion, we compared two groups of patients who underwent sleeve gastrectomy and reached 30 months. Better results, with regard to%EBMIL, comorbidity resolution, QoL, and food tolerance, were observed for the group that actively participated in the follow-up routine compared with the group that was lost to follow-up. Reporting weight loss after 30 months is not enough for long-term result conclusions; we believe that the differences between both groups will increase further with time. This trend is actually being seen already in our other patients not included in the study with more years of active post-operative follow-up. From our experience, getting the most from the sleeve can be attributed to two main factors: surgeon and nutrition, which are dependent on each other and work in complete synchronization with the same prime objective for the patient’s benefit: surgery dependent—leading to a high-pressure system conceived from a narrow stomach lumen with an intact pylorus, resulting in optimal restriction and improved satiety; nutrition dependent—relying on a professional medical team providing constant, ongoing (online) patient support throughout all stages of the bariatric process beginning from the decision process, preparation for the operation, release from the ward, and for many years afterward. These two teams of surgeons and gastroenterologists specializing in nutrition, working side by side, each in their area of specialty, are the main pillars leading to the success of the sleeve. 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