J Gastrointest Surg (2015) 19:1399–1406 DOI 10.1007/s11605-015-2856-6
ORIGINAL ARTICLE
A Multidisciplinary Approach to Medical Weight Loss Prior to Complex Abdominal Wall Reconstruction: Is it Feasible? Michael J. Rosen 1,3 & Kasim Aydogdu 2 & Kevin Grafmiller 2 & Clayton C. Petro 2 & Gregg H. Faiman 2 & Ajita Prabhu 2
Received: 16 March 2015 / Accepted: 8 May 2015 / Published online: 23 May 2015 # 2015 The Society for Surgery of the Alimentary Tract
Abstract Obesity is a major risk factor for perioperative morbidity, especially for patients undergoing complex incisional hernia repair. The feasibility and effectiveness of medical weight loss programs prior to complex abdominal wall reconstruction have not been well characterized. Here, we report our experience collaborating with a medical weight loss specialist utilizing a protein sparing modified fast in order to optimize weight loss prior to complex abdominal wall reconstruction. Morbidly obese patients (body mass index (BMI)>35 kg/m2) evaluated by our medical weight loss specialist prior to complex ventral hernia repair were identified within our prospective database. Our primary outcome measure was the amount of weight lost prior to surgical intervention. Our secondary outcome measure was to determine the maintenance of weight loss during long-term follow-up after the surgical intervention. A total of 25 patients with a BMI>35 kg/m2 were evaluated by our medical weight loss specialist prior to undergoing a planned incisional hernia repair. The mean weight of the patients preoperatively was 128 kg±25 (range 96–205 kg) (mean±standard deviation), and the mean BMI was 49 kg/m2 ±10 (range 36–85). After completion of the preoperative modified protein sparing fast, the mean preoperative weight loss of the group was 24 kg±21 (range 2–80 kg). The overall change in BMI for the group prior to surgery was 9 kg/m2 ±8 (0.6 to 33). The percentage of excess BMI loss and total BMI loss preoperatively was 37 %±23 (2 to 83) and 18 %±12 (1 to 43), respectively. Of the 24 patients that initially lost weight in the program preoperatively, 22 (88 %) successfully maintained their weight loss for the entire study period for an average of 18 months. Collaboration with a medical weight loss specialist and a surgeon with a structured approach using a modified protein sparing fast can successfully result in meaningful weight loss prior to complex abdominal wall reconstruction. The majority of patients in this study were able to maintain their weight loss during long-term follow-up. Utilization of a protein sparing modified fast in collaboration with a medical weight loss specialist is a valuable resource for guiding weight loss in patients with morbid obesity prior to elective complex surgical procedures.
Keywords Ventral hernia . Obesity . Weight loss . Modified protein sparing fast * Michael J. Rosen [email protected]
Introduction 1
Cleveland Clinic Comprehensive Hernia Center, Cleveland Clinic Foundation, 9500 Euclid Avenue A10-425, Cleveland, OH 44195, USA
2
Case Western Reserve, University Hospitals of Cleveland, Cleveland, OH, USA
3
Lerner College of Medicine, Case Western Reserve University, Cleveland Clinic Foundation, Cleveland, OH, USA
Obesity in the USA has become endemic with 34.9 % of the current US population qualifying as obese (body mass index (BMI>30)).1,2 The high prevalence of obesity carries significant implications for hernia surgeons for two main reasons: (1) Obesity represents a major risk factor for the development of hernias and (2) hernias are more difficult to treat in obese
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patients. The incidence of primary inguinal and non-inguinal hernias, as well as the incidence of incisional hernias secondary to abdominal surgery, has been positively correlated with increased BMI.3–5 Additionally, obesity is an even more significant risk factor for the development of an incisional hernia than chronic steroid use.6 Obesity complicates the treatment of hernias by increasing the risk of surgical complications and hernia recurrence. A study of 12,697 inguinal hernia patients from Sweden found that elevated BMI was correlated with an increased risk of postoperative complications.7 Obesity is also an independent risk factor for the development of surgical complications including nosocomial infections, readmissions, transfusion rates, surgical site infections, and abscess formation.8–11 Relative to other comorbidities, obesity was found to be the best predictor of various pulmonary and cardiac surgical complications including atelectasis, pneumonia, perioperative MI, shock, and prolonged hospitalization following hernia surgery.12 Numerous studies have additionally demonstrated that the rate of recurrence for incisional hernias directly correlates with BMI.13–15 In colorectal patients, increased BMI has also been associated with increased costs of care.11 The increased risk associated with operating on obese hernia patients and the fact that perioperative weight loss has been demonstrated to improve surgical outcomes prior to other procedures reveal the need to develop an effective perioperative weight loss strategy for hernia patients.16 No standardized or evidence-based approach to perioperative weight loss for hernia patients currently exists. This lack of guidance coupled with several small studies reporting suboptimal results with medical weight loss has resulted in a relatively nihilistic attitude toward the feasibility of obtaining meaningful preoperative weight loss in patients with complex hernias. While bariatric surgery offers an undeniable durable longterm weight loss solution for many obese patients, its utility in patients with complex hernias is limited. Patients with large defects, multiple prior pieces of intraperitoneal mesh, ongoing infections, and loss of domain often are not candidates for a laparoscopic gastric sleeve or a laparoscopic gastric bypass. Another issue limiting the application of bariatric surgery preoperatively for complex hernia patients is obtaining insurance approval in a timely fashion. This leaves a large population of morbidly obese patients with complex hernia defects that require preoperative optimization and weight loss. Our group has taken an aggressive approach in collaboration with a medical weight loss specialist to mandate preoperative weight loss in morbidly obese patients prior to undertaking complex abdominal wall reconstruction cases. Despite the potential benefits of perioperative weight loss in hernia patients, literature discussing medically supervised weight loss before the operation is limited, especially for ventral hernia patients. Herein, we report our initial experience with the protein sparing modified fast to obtain preoperative weight
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reduction and the long-term success rates for weight maintenance in patients undergoing complex abdominal wall reconstruction.
Methods After obtaining Institutional Review Board approval, all patients with complex hernias evaluated by our comprehensive hernia center that were seen by our medical weight loss specialist were retrospectively evaluated from January 2012 to January 2013. Patient data were gathered retrospectively from a prospectively collected database. Inclusion criteria were any incisional hernia patients who presented to the senior author (MJR) who were morbidly obese (BMI>35 kg/m2) and evaluated by our medical weight loss specialist. Chart reviews were conducted for these patients to obtain demographics, height, weight, calculated BMI, comorbid factors, and hernia characteristics along with weight loss data in the perioperative period. Weight data were collected at each visit and total weight loss, total BMI decrease, and excessive BMI loss was calculated for each patient. Total BMI loss percentage (TBL%) is the ratio of total BMI loss to initial BMI of patient. Excessive BMI loss (EBL%) is the ratio of total BMI loss to the part of the initial BMI exceeding 25.Our program is based on a collaborative effort among the surgical and medical weight loss teams with a clear and unified message communicated to the patient. We feel that it is important to clarify the details of the method by which our patients are introduced to the concept of weight reduction. Obtaining Bbuy in^ from the patients on how preoperative weight loss will improve their outcomes in complex abdominal wall reconstruction is crucial. Our group feels strongly that this is an important discussion and is a Bteachable moment^ that can have a major impact for these patients well beyond their hernia repairs. We have found that many surgeons have reservations about how to introduce weight loss discussions into their practices and therefore do not address this common problem. We have provided a detailed description of how we approach these patients to help facilitate this discussion for other surgeons. During the initial discussion, we avoid recommending a final weight loss goal and following up with the patient only after weight loss has been achieved. In our opinion, this essentially dismisses the surgeon’s role in working with the patient to achieve the best outcomes. Instead, our conversation with these patients highlights several fundamental principles: (1) There are no miracles that occur at our center, and we do not work magic; (2) the patient themselves must take responsibility for their outcomes,; (3) we impart a clear understanding of why obesity results in recurrent hernias, failed repairs, increased infection rate, and unacceptable perioperative morbidity; (4) patients determine their own goals for initial weight loss; (5) surgery
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is only offered to patients who are compliant with our program and tailored goals. One of the most important motivational aspects of having a successful surgeon/patient relationship is that the patients understand our team approach to their operation. We typically explain to the patient that the onus is not only on the surgeon but also on the patient themselves with regard to their ability to control some of the variables involved in their operation. We discuss that many of their hernia recurrences are directly related to the patient and in most cases are not likely due to an issue with the technical ability of the prior surgeon. Recognizing that the situation requires a new paradigm; we discuss furthermore that while we as the surgical team may use a different technical approach, we also demand that the patient participate in their own care and become a part of the solution. In our practice, we focus on two main modifiable preoperative risk factors: smoking cessation and weight reduction. This paper will focus on weight reduction, but the same approach is used to engage patients for smoking cessation. After establishing that weight loss is critical to a successful outcome, we have the patient set a reasonable weight loss goal over the next 3 months. It is imperative that the patient sets this goal. We do not have a minimum or maximum; instead, we feel that it is important for this to be at the discretion of the patient, which lends itself to a feeling of empowerment and also accountability on the part of the patient. Once the weight loss goal has been set, we document it in the medical record and plan for a follow-up appointment in 3 months, at which time the weight will be rechecked, and surgery will be discussed only if the goal has been met. Typically, a goal of 11–16 kg (20–30 lbs) of weight loss was set by most patients in our practice. When the surgical team sees the patient for their return visit after 3 months, the specific goals and their success or failure are discussed and addressed. For those patients that achieve their initial goal, we emphasize positive reinforcement and encouragement and then go on to set an ideal weight goal which should be achieved in order to proceed with surgery. We strive for a BMI less than 40 kg/m2. However, we do recognize that not all patients can achieve that goal depending on their initial weight. In addition, some patients plateau and likely benefit from undergoing surgical correction of their hernia to enable increased exercise capability and further weight loss. The surgical team follows the patients regularly every 3 months to monitor their progress and demonstrate the engagement of both the surgeon and the patient in the ongoing weight loss process. We have found that the surgeon taking an active role in this process greatly enhances patient compliance and long-term success. Those patients that do not achieve their goal follow a different algorithm. While we have used several different motivational tactics, we have found the following to be most successful: We discuss with the patients that their tailored plan was to lose a specified amount of weight. We then ask them to
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grade their performance using an A through F with a plus and minus scale. When they give themselves a poor grade, we ask them if they would accept the same grade from their surgeon during their operation. This approach suggests that if a patient would not accept a C performance from their surgeon, neither should they accept a C performance of themselves. We then reestablish their original goal and set a 3-month follow-up visit to confirm that the weight loss goal is successfully achieved. Our medical weight loss specialist utilizes a protein sparing modified fast to help achieve their targeted weight loss. The PSMF is based on a diet of 1.2–1.4 g/kg/day of protein (calculated from their ideal weight of a BMI of 25), 40 mg of carbohydrates, and vitamin and mineral supplementation with total caloric intake of 50, one was the only patient that did not lose weight, and the other patient went from a BMI of 85 to 52. Importantly, two patients became non-obese with a BMI change of 46 to 29 and 38 to 29, respectively. The overall change in BMI for the group prior to surgery was 9±8 kg/ m2 (0.6 to 33). The percentage of excess BMI loss and total BMI loss preoperatively were 37±23 % (2 to 83) and 18± 12 % (1 to 43), respectively. Long-Term Weight Loss To determine the long-term success of the weight loss program, patient’s weights were evaluated postoperatively at 6, 12, and 18 months or the longest available follow-up point. The majority of patients successfully maintained their weight loss. Of the 24 patients that initially lost weight in the program preoperatively, 22 (88 %) successfully maintained their weight loss for the entire study period for an average of 18 months. Two patients who successfully lost 7 and 12 kg preoperatively regained all of their weight by long-term follow up. The overall change in weight of the study group was fairly constant during long-term follow up (Fig. 1). At longterm follow-up, the mean BMI was 40±8 kg/m2 (27–61), and the change in BMI throughout the study is demonstrated in Fig. 2. The long-term percent of excess BMI loss and total BMI loss were 35±25 % (−8 to 83) and 17±12 % (−3 to 39). The change in EBL and TBL are displayed in Figs. 3 and 4, respectively. 140 130
The average duration of the preoperative program from time of initial visit with the surgical team to the day of surgery was 17 months (range 6 to 36). The mean weight of the patients preoperatively was 128±25 kg (range 96–205 kg). The mean preoperative weight loss of the group was 24±21 kg (range 2– 80 kg). The percent of total weight loss was 18±12 % (range 1 to 43). Three patients lost less than 3 kg (range 2 to 3 kg) during the preoperative phase. Of those three patients, two developed symptoms related to their hernia and had their hernias repaired electively. Both of those patients returned to the
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Discussion Preoperative optimization of a patient undergoing complex abdominal wall reconstructions is imperative to maximize the chances of achieving a successful outcome. While many efforts to optimize glucose control, smoking cessation, and nutritional support have shown significant promise, there have been very few publications addressing non-operative treatment strategies to reduce obesity. This study demonstrates that in our cohort of patients, with a motivated and dedicated surgical and medical weight loss team, a significant portion of patients can successfully achieve medically supervised weight loss prior to complex abdominal wall reconstruction. Even more encouraging is that during long-term follow-up, the vast majority of these patients were able to successfully maintain their weight loss. Other surgeons can apply these techniques to form a collaborative approach to weight loss prior to other complex surgical procedures. Obesity is a common and serious risk factor that can lead to poor surgical outcomes in hernia patients. Therefore, an effective perioperative medical weight loss program could significantly improve the outcomes of hernia repairs in obese patients. We attempted to determine the feasibility and efficacy of a specific medical weight loss method, the protein sparing modified fast, when administered in a professional and organized manner by a weight loss specialist. Our results indicate that clinically significant weight loss can be achieved in a safe 50 45 40 35 EBL (%)
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Fig. 3 Percent of excess BMI loss during long-term follow-up. EBL%=(total BMI loss)/(initial BMI−25)
manner via protein sparing modified fast directed by a medical weight loss specialist. Other groups have reported alternative methods of preoperative weight reduction. Eid et al utilized a 12-week, lowcalorie, liquid diet for two morbidly obese hernia patients who were symptomatic with complex hernias.18 Their patients lost weight preoperatively and went on to have a laparoscopic ventral hernia repair and concomitant sleeve gastrectomy. These authors are also part of a high-volume bariatric program that had close collaboration with a medical weight loss specialist monitoring the diet. Another study was conducted utilizing a weight loss program that limited the amount of carbohydrate intake with a total caloric intake of 1500 cal/day.19 These authors followed a fairly healthy group of patients with a mean pre-diet BMI of 29 kg/m2. Patients successfully lost an average of 11.51 kg in 2–6 months. Unlike our series, the vast majority of patients began with a BMI less than 35 kg/m2 and had small primary ventral hernias. Despite these differences, their study again highlights the importance of surgeons providing the motivation for preoperative weight loss. Other groups have tried to establish the specific role that a surgeon might play in introducing weight loss at the time of an elective general surgery procedure and in increasing the motivation for patients to lose weight. Goldberg et al. identified nine obese patients needing an elective general surgical procedure of which eight/nine were ventral hernia repairs.20 While very few details were provided in their manuscript as to exactly how the surgeon attempted to obtain buy in from the patients or introduce the concept of weight loss, it appears that the surgeon set a defined BMI goal. These patients were then placed on a liquid meal replacement diet of 800 cal/day. They were managed in a comprehensive weight loss program. To determine the motivation of a potential surgical procedure on achieving weight loss goals, they also compared these patients to a cohort of obese patients undergoing a similar diet plan without the need for a surgical procedure. This group reported much less favorable results than our cohort. Only five of nine patients successfully met their weight loss goal. Even more disappointing was the fact that the nonsurgical group lost significantly more weight. There are several possible explanations as to why our results are so different. Having a patient
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set their own initial goal and acknowledging their initial success prior to their ultimate goal might provide the needed motivation to reach their ultimate goal. Although the actual weight loss goals were not explicitly stated in their series, it is possible that their definition of success was simply different than ours and could explain the difference. In other words, their patients might not have all reached a BMI less than 40 kg/m2 but could have still lost weight. However, a mean weight loss of over 50 lbs in our cohort certainly represents a measurable success with our approach. The role of bariatric surgery in hernia repair has undergone considerable investigation. The presence and management of a small ventral hernia during bariatric surgery has long plagued obesity surgeons. Certain authors have successfully reported small series with short-term follow-up using a simultaneous laparoscopic ventral hernia repair and bariatric surgery.21–25 It is important to note that the majority of the hernias in those series are very small, and while they pose risk to the bariatric surgery procedure, they do not present the challenges required to reconstruct a complex hernia defect. In our series, none of our patients were amenable to laparoscopic ventral hernia repair, and thus, these results do not apply to our study group. However, based on the success of some of these groups, other authors have begun to advocate for a simultaneous approach to more challenging ventral hernias at the time of bariatric surgery.21 In our view, this approach poses several possible concerns. The use of synthetic mesh in these clean contaminated cases is controversial and could result in devastating long-term mesh infections. However, it should be noted that over 50 % of the patients in our series did have some level of contamination during their ultimate hernia repair, and synthetic mesh was utilized in the vast majority without major complications. Thus, the fear of a mesh infection during a concomitant bariatric surgical procedure might be overstated. Another concern of simultaneous bariatric surgery and complex ventral hernia repair is that the forced starvation and potential wound-healing derangements associated with bariatric surgery might negatively impact the complex hernia repairs in the short therm. Despite these concerns, a small series of 12 patients undergoing concomitant laparoscopic Roux en Y gastric bypass and ventral hernia repair showed no mesh infections and a 20 % recurrence rate with short-term follow-up.26 In our laboratory, we evaluated the effect of gastric bypass and sleeve gastrectomy on wound healing in an animal model. We found that these bariatric procedures potentially negatively impact collagen formation and tensile strength of a midline fascial wound closure.27 Given these concerns, at this point, we feel that concomitant bariatric surgery and complex ventral hernia repair should be evaluated in carefully designed prospective randomized trials to define the safety of its role in managing these challenging cases. It is also important to point out that the mean time to maximize the medically supervised weight loss program and
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eventual hernia repair was 17 months in our series. This time frame is certainly within the range of achieving insurance approval and completing a surgical weight loss program prior to ventral hernia repair. Ultimately, a collaborative approach between the abdominal wall reconstructive surgeon, medical weight loss team, and the bariatric surgical team is critical to provide the most appropriate preoperative regimen for each individual patient to maximize weight loss. The protein sparing modified fast used in the present study produced larger decreases in BMI compared to similar nutritional modifications used in other studies. The protein sparing fasts have been shown to produce rapid short-term weight loss in non-surgical patients. Sukkar et al. placed 22 obese patients on a protein sparing fast, and these patients lost an average of 6.2 kg in a month.28 In a second study, Capello et al. gave patients ketogenic diet, which is a modified version of the protein sparing fast diet.29 The diet was administered to 188 patients through a nasogastric tube during three 10-day cycles. Ninety-seven percent of patients tolerated the diet, and they lost an average of 14.4 kg over the three-cycle period. Our study demonstrated the ability of a protein sparing fast to achieve rapid weight loss, making it ideal for preoperative optimization. It also showed excellent long-term success with the majority of patients maintaining their weight loss throughout the study. Although the protein sparing modified fast is an effective method for weight loss, such an extreme diet requires regular monitoring by a weight loss specialist to ensure patient safety. Supplemental vitamins and minerals must be regularly administered, and patients must be seen each month by a weight loss specialist to avoid serious potential adverse effects. By administering this diet in a controlled setting with a medical weight loss specialist, none of our patients suffered complications directly related to the diet. However, it deserves mention that the applicability of this diet is hindered by the fact that patients are dependent on a nutritional team and cannot safely self-administer this diet. Likely, as hospital systems and surgical groups are being increasingly measured on quality, it seems reasonable to make the investment in medical weight loss specialists to optimize surgical patients prior to elective complex surgeries. Our study has several limitations that deserve mention. One of the major limitations of this study is that we did not explicitly measure the motivational factors of the patients that made them successful at losing weight. While we assume that they are our initial discussion, use of a multi-disciplinary team, and careful follow-up, we could be wrong. In fact, because we are a tertiary referral center, many patients might see referral to our hernia center as a Blast chance^ to have their hernias repaired and therefore might be more predisposed to consider weight loss. That fact alone might give us some advantage that other surgeons cannot leverage. While we certainly acknowledge that limitation, we do feel that every surgeon has little to lose and much to gain by attempting our weight loss approach.
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In fact, the concern that observing these hernias in patients during weight loss might actually result in more incarcerations and strangulations was not supported in our series. We did have two patients that went on to develop symptoms, but both were repaired nonemergently and eventually rejoined the program. Other questions related to our approach revolve around the long-term success of the weight loss. Certainly, we continue to follow these patients, and long-term follow-up out to 5 to 10 years is mandatory to definitively answer that question. However, it seems that the majority of patients are able to successfully keep the weight off for at least the first 1.5 years after the repair. This study is also a single-arm study with no control group. Since all of our patients did not reach a non obese BMI, it is difficult to say that their weight loss resulted in an improved outcome. While this is clearly a deficit of the study, it is generally accepted that a 50-lbs weight loss may at least result in a technically less demanding operation for the surgeon. We also do not have the actual denominator of all the obese patients seen in our practice that were referred for medical weight loss and did not follow through. While we feel that this number is fairly low, we can confirm that none of the patients that did not enroll in the program went on to have surgery in our practice, with the exception of the two patients that had more urgent symptoms reported in this series. It is likely that none of these patients had surgery at another center, as over 95 % of our practice is referred from other surgeons. However, we do acknowledge that our program will only work for a motivated patient that is willing to take part in the process. It is well accepted that any patient that will not participate in their weight loss success will not succeed in any surgical or medical weight loss program. In conclusion, we have demonstrated that a collaborative approach to preoperative medically supervised weight loss using a protein sparing modified fast is feasible and can result in significant preoperative weight reduction for patients undergoing complex ventral hernia repairs. The majority of these patients are able to maintain their weight loss during long-term follow-up. We recommend that all surgeons engage a local medical weight loss specialist with experience administering the modified protein sparing fast and incorporate a team approach to preoperative weight loss in morbidly obese patients with hernias.
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Schuster R, Curet MJ, Alami RS, Morton JM, Wren SM, Safadi BY. Concurrent gastric bypass and repair of anterior abdominal wall hernias. Obes Surg. 2006;16(9):1205-8. 27. Krpata DM1, Criss CN, Gao Y, Sadava EE, Anderson JM, Novitsky YW, Rosen MJ. Effects of weight reduction surgery on the abdominal wall fascial wound healing process. J Surg Res. 2013 Sep;184(1):78-83. doi: 10.1016/j.jss.2013.05.034. Epub 2013 May 31. 28. Sukkar SG, Signori A, Borrini C, et al. Feasibility of proteinsparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test). Med J Nutrition Metab. 2013;6:165-176. doi: 10.1007/s12349-013-0126-2. 29. Cappello G, Franceschelli A, Cappello A, De Luca P. Weight loss and body composition changes following three sequential cycles of ketogenic enteral nutrition. J Res Med Sci. 2012;17(12):1114-8. Available at: http://www.pubmedcentral.nih.gov/articlerender.fcgi? artid=3703161&tool=pmcentrez&rendertype=abstract. Accessed December 4, 2014.
ORIGINAL ARTICLE
A Multidisciplinary Approach to Medical Weight Loss Prior to Complex Abdominal Wall Reconstruction: Is it Feasible? Michael J. Rosen 1,3 & Kasim Aydogdu 2 & Kevin Grafmiller 2 & Clayton C. Petro 2 & Gregg H. Faiman 2 & Ajita Prabhu 2
Received: 16 March 2015 / Accepted: 8 May 2015 / Published online: 23 May 2015 # 2015 The Society for Surgery of the Alimentary Tract
Abstract Obesity is a major risk factor for perioperative morbidity, especially for patients undergoing complex incisional hernia repair. The feasibility and effectiveness of medical weight loss programs prior to complex abdominal wall reconstruction have not been well characterized. Here, we report our experience collaborating with a medical weight loss specialist utilizing a protein sparing modified fast in order to optimize weight loss prior to complex abdominal wall reconstruction. Morbidly obese patients (body mass index (BMI)>35 kg/m2) evaluated by our medical weight loss specialist prior to complex ventral hernia repair were identified within our prospective database. Our primary outcome measure was the amount of weight lost prior to surgical intervention. Our secondary outcome measure was to determine the maintenance of weight loss during long-term follow-up after the surgical intervention. A total of 25 patients with a BMI>35 kg/m2 were evaluated by our medical weight loss specialist prior to undergoing a planned incisional hernia repair. The mean weight of the patients preoperatively was 128 kg±25 (range 96–205 kg) (mean±standard deviation), and the mean BMI was 49 kg/m2 ±10 (range 36–85). After completion of the preoperative modified protein sparing fast, the mean preoperative weight loss of the group was 24 kg±21 (range 2–80 kg). The overall change in BMI for the group prior to surgery was 9 kg/m2 ±8 (0.6 to 33). The percentage of excess BMI loss and total BMI loss preoperatively was 37 %±23 (2 to 83) and 18 %±12 (1 to 43), respectively. Of the 24 patients that initially lost weight in the program preoperatively, 22 (88 %) successfully maintained their weight loss for the entire study period for an average of 18 months. Collaboration with a medical weight loss specialist and a surgeon with a structured approach using a modified protein sparing fast can successfully result in meaningful weight loss prior to complex abdominal wall reconstruction. The majority of patients in this study were able to maintain their weight loss during long-term follow-up. Utilization of a protein sparing modified fast in collaboration with a medical weight loss specialist is a valuable resource for guiding weight loss in patients with morbid obesity prior to elective complex surgical procedures.
Keywords Ventral hernia . Obesity . Weight loss . Modified protein sparing fast * Michael J. Rosen [email protected]
Introduction 1
Cleveland Clinic Comprehensive Hernia Center, Cleveland Clinic Foundation, 9500 Euclid Avenue A10-425, Cleveland, OH 44195, USA
2
Case Western Reserve, University Hospitals of Cleveland, Cleveland, OH, USA
3
Lerner College of Medicine, Case Western Reserve University, Cleveland Clinic Foundation, Cleveland, OH, USA
Obesity in the USA has become endemic with 34.9 % of the current US population qualifying as obese (body mass index (BMI>30)).1,2 The high prevalence of obesity carries significant implications for hernia surgeons for two main reasons: (1) Obesity represents a major risk factor for the development of hernias and (2) hernias are more difficult to treat in obese
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patients. The incidence of primary inguinal and non-inguinal hernias, as well as the incidence of incisional hernias secondary to abdominal surgery, has been positively correlated with increased BMI.3–5 Additionally, obesity is an even more significant risk factor for the development of an incisional hernia than chronic steroid use.6 Obesity complicates the treatment of hernias by increasing the risk of surgical complications and hernia recurrence. A study of 12,697 inguinal hernia patients from Sweden found that elevated BMI was correlated with an increased risk of postoperative complications.7 Obesity is also an independent risk factor for the development of surgical complications including nosocomial infections, readmissions, transfusion rates, surgical site infections, and abscess formation.8–11 Relative to other comorbidities, obesity was found to be the best predictor of various pulmonary and cardiac surgical complications including atelectasis, pneumonia, perioperative MI, shock, and prolonged hospitalization following hernia surgery.12 Numerous studies have additionally demonstrated that the rate of recurrence for incisional hernias directly correlates with BMI.13–15 In colorectal patients, increased BMI has also been associated with increased costs of care.11 The increased risk associated with operating on obese hernia patients and the fact that perioperative weight loss has been demonstrated to improve surgical outcomes prior to other procedures reveal the need to develop an effective perioperative weight loss strategy for hernia patients.16 No standardized or evidence-based approach to perioperative weight loss for hernia patients currently exists. This lack of guidance coupled with several small studies reporting suboptimal results with medical weight loss has resulted in a relatively nihilistic attitude toward the feasibility of obtaining meaningful preoperative weight loss in patients with complex hernias. While bariatric surgery offers an undeniable durable longterm weight loss solution for many obese patients, its utility in patients with complex hernias is limited. Patients with large defects, multiple prior pieces of intraperitoneal mesh, ongoing infections, and loss of domain often are not candidates for a laparoscopic gastric sleeve or a laparoscopic gastric bypass. Another issue limiting the application of bariatric surgery preoperatively for complex hernia patients is obtaining insurance approval in a timely fashion. This leaves a large population of morbidly obese patients with complex hernia defects that require preoperative optimization and weight loss. Our group has taken an aggressive approach in collaboration with a medical weight loss specialist to mandate preoperative weight loss in morbidly obese patients prior to undertaking complex abdominal wall reconstruction cases. Despite the potential benefits of perioperative weight loss in hernia patients, literature discussing medically supervised weight loss before the operation is limited, especially for ventral hernia patients. Herein, we report our initial experience with the protein sparing modified fast to obtain preoperative weight
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reduction and the long-term success rates for weight maintenance in patients undergoing complex abdominal wall reconstruction.
Methods After obtaining Institutional Review Board approval, all patients with complex hernias evaluated by our comprehensive hernia center that were seen by our medical weight loss specialist were retrospectively evaluated from January 2012 to January 2013. Patient data were gathered retrospectively from a prospectively collected database. Inclusion criteria were any incisional hernia patients who presented to the senior author (MJR) who were morbidly obese (BMI>35 kg/m2) and evaluated by our medical weight loss specialist. Chart reviews were conducted for these patients to obtain demographics, height, weight, calculated BMI, comorbid factors, and hernia characteristics along with weight loss data in the perioperative period. Weight data were collected at each visit and total weight loss, total BMI decrease, and excessive BMI loss was calculated for each patient. Total BMI loss percentage (TBL%) is the ratio of total BMI loss to initial BMI of patient. Excessive BMI loss (EBL%) is the ratio of total BMI loss to the part of the initial BMI exceeding 25.Our program is based on a collaborative effort among the surgical and medical weight loss teams with a clear and unified message communicated to the patient. We feel that it is important to clarify the details of the method by which our patients are introduced to the concept of weight reduction. Obtaining Bbuy in^ from the patients on how preoperative weight loss will improve their outcomes in complex abdominal wall reconstruction is crucial. Our group feels strongly that this is an important discussion and is a Bteachable moment^ that can have a major impact for these patients well beyond their hernia repairs. We have found that many surgeons have reservations about how to introduce weight loss discussions into their practices and therefore do not address this common problem. We have provided a detailed description of how we approach these patients to help facilitate this discussion for other surgeons. During the initial discussion, we avoid recommending a final weight loss goal and following up with the patient only after weight loss has been achieved. In our opinion, this essentially dismisses the surgeon’s role in working with the patient to achieve the best outcomes. Instead, our conversation with these patients highlights several fundamental principles: (1) There are no miracles that occur at our center, and we do not work magic; (2) the patient themselves must take responsibility for their outcomes,; (3) we impart a clear understanding of why obesity results in recurrent hernias, failed repairs, increased infection rate, and unacceptable perioperative morbidity; (4) patients determine their own goals for initial weight loss; (5) surgery
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is only offered to patients who are compliant with our program and tailored goals. One of the most important motivational aspects of having a successful surgeon/patient relationship is that the patients understand our team approach to their operation. We typically explain to the patient that the onus is not only on the surgeon but also on the patient themselves with regard to their ability to control some of the variables involved in their operation. We discuss that many of their hernia recurrences are directly related to the patient and in most cases are not likely due to an issue with the technical ability of the prior surgeon. Recognizing that the situation requires a new paradigm; we discuss furthermore that while we as the surgical team may use a different technical approach, we also demand that the patient participate in their own care and become a part of the solution. In our practice, we focus on two main modifiable preoperative risk factors: smoking cessation and weight reduction. This paper will focus on weight reduction, but the same approach is used to engage patients for smoking cessation. After establishing that weight loss is critical to a successful outcome, we have the patient set a reasonable weight loss goal over the next 3 months. It is imperative that the patient sets this goal. We do not have a minimum or maximum; instead, we feel that it is important for this to be at the discretion of the patient, which lends itself to a feeling of empowerment and also accountability on the part of the patient. Once the weight loss goal has been set, we document it in the medical record and plan for a follow-up appointment in 3 months, at which time the weight will be rechecked, and surgery will be discussed only if the goal has been met. Typically, a goal of 11–16 kg (20–30 lbs) of weight loss was set by most patients in our practice. When the surgical team sees the patient for their return visit after 3 months, the specific goals and their success or failure are discussed and addressed. For those patients that achieve their initial goal, we emphasize positive reinforcement and encouragement and then go on to set an ideal weight goal which should be achieved in order to proceed with surgery. We strive for a BMI less than 40 kg/m2. However, we do recognize that not all patients can achieve that goal depending on their initial weight. In addition, some patients plateau and likely benefit from undergoing surgical correction of their hernia to enable increased exercise capability and further weight loss. The surgical team follows the patients regularly every 3 months to monitor their progress and demonstrate the engagement of both the surgeon and the patient in the ongoing weight loss process. We have found that the surgeon taking an active role in this process greatly enhances patient compliance and long-term success. Those patients that do not achieve their goal follow a different algorithm. While we have used several different motivational tactics, we have found the following to be most successful: We discuss with the patients that their tailored plan was to lose a specified amount of weight. We then ask them to
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grade their performance using an A through F with a plus and minus scale. When they give themselves a poor grade, we ask them if they would accept the same grade from their surgeon during their operation. This approach suggests that if a patient would not accept a C performance from their surgeon, neither should they accept a C performance of themselves. We then reestablish their original goal and set a 3-month follow-up visit to confirm that the weight loss goal is successfully achieved. Our medical weight loss specialist utilizes a protein sparing modified fast to help achieve their targeted weight loss. The PSMF is based on a diet of 1.2–1.4 g/kg/day of protein (calculated from their ideal weight of a BMI of 25), 40 mg of carbohydrates, and vitamin and mineral supplementation with total caloric intake of 50, one was the only patient that did not lose weight, and the other patient went from a BMI of 85 to 52. Importantly, two patients became non-obese with a BMI change of 46 to 29 and 38 to 29, respectively. The overall change in BMI for the group prior to surgery was 9±8 kg/ m2 (0.6 to 33). The percentage of excess BMI loss and total BMI loss preoperatively were 37±23 % (2 to 83) and 18± 12 % (1 to 43), respectively. Long-Term Weight Loss To determine the long-term success of the weight loss program, patient’s weights were evaluated postoperatively at 6, 12, and 18 months or the longest available follow-up point. The majority of patients successfully maintained their weight loss. Of the 24 patients that initially lost weight in the program preoperatively, 22 (88 %) successfully maintained their weight loss for the entire study period for an average of 18 months. Two patients who successfully lost 7 and 12 kg preoperatively regained all of their weight by long-term follow up. The overall change in weight of the study group was fairly constant during long-term follow up (Fig. 1). At longterm follow-up, the mean BMI was 40±8 kg/m2 (27–61), and the change in BMI throughout the study is demonstrated in Fig. 2. The long-term percent of excess BMI loss and total BMI loss were 35±25 % (−8 to 83) and 17±12 % (−3 to 39). The change in EBL and TBL are displayed in Figs. 3 and 4, respectively. 140 130
The average duration of the preoperative program from time of initial visit with the surgical team to the day of surgery was 17 months (range 6 to 36). The mean weight of the patients preoperatively was 128±25 kg (range 96–205 kg). The mean preoperative weight loss of the group was 24±21 kg (range 2– 80 kg). The percent of total weight loss was 18±12 % (range 1 to 43). Three patients lost less than 3 kg (range 2 to 3 kg) during the preoperative phase. Of those three patients, two developed symptoms related to their hernia and had their hernias repaired electively. Both of those patients returned to the
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Discussion Preoperative optimization of a patient undergoing complex abdominal wall reconstructions is imperative to maximize the chances of achieving a successful outcome. While many efforts to optimize glucose control, smoking cessation, and nutritional support have shown significant promise, there have been very few publications addressing non-operative treatment strategies to reduce obesity. This study demonstrates that in our cohort of patients, with a motivated and dedicated surgical and medical weight loss team, a significant portion of patients can successfully achieve medically supervised weight loss prior to complex abdominal wall reconstruction. Even more encouraging is that during long-term follow-up, the vast majority of these patients were able to successfully maintain their weight loss. Other surgeons can apply these techniques to form a collaborative approach to weight loss prior to other complex surgical procedures. Obesity is a common and serious risk factor that can lead to poor surgical outcomes in hernia patients. Therefore, an effective perioperative medical weight loss program could significantly improve the outcomes of hernia repairs in obese patients. We attempted to determine the feasibility and efficacy of a specific medical weight loss method, the protein sparing modified fast, when administered in a professional and organized manner by a weight loss specialist. Our results indicate that clinically significant weight loss can be achieved in a safe 50 45 40 35 EBL (%)
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Fig. 3 Percent of excess BMI loss during long-term follow-up. EBL%=(total BMI loss)/(initial BMI−25)
manner via protein sparing modified fast directed by a medical weight loss specialist. Other groups have reported alternative methods of preoperative weight reduction. Eid et al utilized a 12-week, lowcalorie, liquid diet for two morbidly obese hernia patients who were symptomatic with complex hernias.18 Their patients lost weight preoperatively and went on to have a laparoscopic ventral hernia repair and concomitant sleeve gastrectomy. These authors are also part of a high-volume bariatric program that had close collaboration with a medical weight loss specialist monitoring the diet. Another study was conducted utilizing a weight loss program that limited the amount of carbohydrate intake with a total caloric intake of 1500 cal/day.19 These authors followed a fairly healthy group of patients with a mean pre-diet BMI of 29 kg/m2. Patients successfully lost an average of 11.51 kg in 2–6 months. Unlike our series, the vast majority of patients began with a BMI less than 35 kg/m2 and had small primary ventral hernias. Despite these differences, their study again highlights the importance of surgeons providing the motivation for preoperative weight loss. Other groups have tried to establish the specific role that a surgeon might play in introducing weight loss at the time of an elective general surgery procedure and in increasing the motivation for patients to lose weight. Goldberg et al. identified nine obese patients needing an elective general surgical procedure of which eight/nine were ventral hernia repairs.20 While very few details were provided in their manuscript as to exactly how the surgeon attempted to obtain buy in from the patients or introduce the concept of weight loss, it appears that the surgeon set a defined BMI goal. These patients were then placed on a liquid meal replacement diet of 800 cal/day. They were managed in a comprehensive weight loss program. To determine the motivation of a potential surgical procedure on achieving weight loss goals, they also compared these patients to a cohort of obese patients undergoing a similar diet plan without the need for a surgical procedure. This group reported much less favorable results than our cohort. Only five of nine patients successfully met their weight loss goal. Even more disappointing was the fact that the nonsurgical group lost significantly more weight. There are several possible explanations as to why our results are so different. Having a patient
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set their own initial goal and acknowledging their initial success prior to their ultimate goal might provide the needed motivation to reach their ultimate goal. Although the actual weight loss goals were not explicitly stated in their series, it is possible that their definition of success was simply different than ours and could explain the difference. In other words, their patients might not have all reached a BMI less than 40 kg/m2 but could have still lost weight. However, a mean weight loss of over 50 lbs in our cohort certainly represents a measurable success with our approach. The role of bariatric surgery in hernia repair has undergone considerable investigation. The presence and management of a small ventral hernia during bariatric surgery has long plagued obesity surgeons. Certain authors have successfully reported small series with short-term follow-up using a simultaneous laparoscopic ventral hernia repair and bariatric surgery.21–25 It is important to note that the majority of the hernias in those series are very small, and while they pose risk to the bariatric surgery procedure, they do not present the challenges required to reconstruct a complex hernia defect. In our series, none of our patients were amenable to laparoscopic ventral hernia repair, and thus, these results do not apply to our study group. However, based on the success of some of these groups, other authors have begun to advocate for a simultaneous approach to more challenging ventral hernias at the time of bariatric surgery.21 In our view, this approach poses several possible concerns. The use of synthetic mesh in these clean contaminated cases is controversial and could result in devastating long-term mesh infections. However, it should be noted that over 50 % of the patients in our series did have some level of contamination during their ultimate hernia repair, and synthetic mesh was utilized in the vast majority without major complications. Thus, the fear of a mesh infection during a concomitant bariatric surgical procedure might be overstated. Another concern of simultaneous bariatric surgery and complex ventral hernia repair is that the forced starvation and potential wound-healing derangements associated with bariatric surgery might negatively impact the complex hernia repairs in the short therm. Despite these concerns, a small series of 12 patients undergoing concomitant laparoscopic Roux en Y gastric bypass and ventral hernia repair showed no mesh infections and a 20 % recurrence rate with short-term follow-up.26 In our laboratory, we evaluated the effect of gastric bypass and sleeve gastrectomy on wound healing in an animal model. We found that these bariatric procedures potentially negatively impact collagen formation and tensile strength of a midline fascial wound closure.27 Given these concerns, at this point, we feel that concomitant bariatric surgery and complex ventral hernia repair should be evaluated in carefully designed prospective randomized trials to define the safety of its role in managing these challenging cases. It is also important to point out that the mean time to maximize the medically supervised weight loss program and
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eventual hernia repair was 17 months in our series. This time frame is certainly within the range of achieving insurance approval and completing a surgical weight loss program prior to ventral hernia repair. Ultimately, a collaborative approach between the abdominal wall reconstructive surgeon, medical weight loss team, and the bariatric surgical team is critical to provide the most appropriate preoperative regimen for each individual patient to maximize weight loss. The protein sparing modified fast used in the present study produced larger decreases in BMI compared to similar nutritional modifications used in other studies. The protein sparing fasts have been shown to produce rapid short-term weight loss in non-surgical patients. Sukkar et al. placed 22 obese patients on a protein sparing fast, and these patients lost an average of 6.2 kg in a month.28 In a second study, Capello et al. gave patients ketogenic diet, which is a modified version of the protein sparing fast diet.29 The diet was administered to 188 patients through a nasogastric tube during three 10-day cycles. Ninety-seven percent of patients tolerated the diet, and they lost an average of 14.4 kg over the three-cycle period. Our study demonstrated the ability of a protein sparing fast to achieve rapid weight loss, making it ideal for preoperative optimization. It also showed excellent long-term success with the majority of patients maintaining their weight loss throughout the study. Although the protein sparing modified fast is an effective method for weight loss, such an extreme diet requires regular monitoring by a weight loss specialist to ensure patient safety. Supplemental vitamins and minerals must be regularly administered, and patients must be seen each month by a weight loss specialist to avoid serious potential adverse effects. By administering this diet in a controlled setting with a medical weight loss specialist, none of our patients suffered complications directly related to the diet. However, it deserves mention that the applicability of this diet is hindered by the fact that patients are dependent on a nutritional team and cannot safely self-administer this diet. Likely, as hospital systems and surgical groups are being increasingly measured on quality, it seems reasonable to make the investment in medical weight loss specialists to optimize surgical patients prior to elective complex surgeries. Our study has several limitations that deserve mention. One of the major limitations of this study is that we did not explicitly measure the motivational factors of the patients that made them successful at losing weight. While we assume that they are our initial discussion, use of a multi-disciplinary team, and careful follow-up, we could be wrong. In fact, because we are a tertiary referral center, many patients might see referral to our hernia center as a Blast chance^ to have their hernias repaired and therefore might be more predisposed to consider weight loss. That fact alone might give us some advantage that other surgeons cannot leverage. While we certainly acknowledge that limitation, we do feel that every surgeon has little to lose and much to gain by attempting our weight loss approach.
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In fact, the concern that observing these hernias in patients during weight loss might actually result in more incarcerations and strangulations was not supported in our series. We did have two patients that went on to develop symptoms, but both were repaired nonemergently and eventually rejoined the program. Other questions related to our approach revolve around the long-term success of the weight loss. Certainly, we continue to follow these patients, and long-term follow-up out to 5 to 10 years is mandatory to definitively answer that question. However, it seems that the majority of patients are able to successfully keep the weight off for at least the first 1.5 years after the repair. This study is also a single-arm study with no control group. Since all of our patients did not reach a non obese BMI, it is difficult to say that their weight loss resulted in an improved outcome. While this is clearly a deficit of the study, it is generally accepted that a 50-lbs weight loss may at least result in a technically less demanding operation for the surgeon. We also do not have the actual denominator of all the obese patients seen in our practice that were referred for medical weight loss and did not follow through. While we feel that this number is fairly low, we can confirm that none of the patients that did not enroll in the program went on to have surgery in our practice, with the exception of the two patients that had more urgent symptoms reported in this series. It is likely that none of these patients had surgery at another center, as over 95 % of our practice is referred from other surgeons. However, we do acknowledge that our program will only work for a motivated patient that is willing to take part in the process. It is well accepted that any patient that will not participate in their weight loss success will not succeed in any surgical or medical weight loss program. In conclusion, we have demonstrated that a collaborative approach to preoperative medically supervised weight loss using a protein sparing modified fast is feasible and can result in significant preoperative weight reduction for patients undergoing complex ventral hernia repairs. The majority of these patients are able to maintain their weight loss during long-term follow-up. We recommend that all surgeons engage a local medical weight loss specialist with experience administering the modified protein sparing fast and incorporate a team approach to preoperative weight loss in morbidly obese patients with hernias.
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