Thrombotic and hemorrhagic risk in bariatric surgery with multimodal rehabilitation programs comparing 2 reduced guidelines for pharmacological prophylaxis.

OBJECTIVE: To determine the thrombotic and hemorrhagic risk in bariatric surgery with multimodal rehabilitation programs, comparing two guidelines of pharmacological prophylaxis recommended in the Guide to the Spanish Society for Obesity Surgery and the Obesity Section of the AEC. METHODS: Cohorts retrospective study from January-2010 to December-2019. Cases of vertical gastrectomy or gastric bypass were recorded, systematically applying multimodal rehabilitation protocols. Two reduced chemoprophylaxis regimens were analyzed, starting after surgery and maintained for 10 days; one with fondaparinux (Arixtra®) at a fixed dose of 2.5mg/day and the other with enoxaparin (Clexane®) with a single daily dose adjusted to BMI: 40mg/day for BMI of 35-40 and 60mg/day for BMI 40-60. RESULTS: 675 patients were included; 354 with Fondaparinux-Arixtra® during the period 2010-2015 and 321 with Enoxaparin-Clexane® during the period 2016-2019. There were no cases of DVT or clinical PE. However, the incidence of hemorrhage requiring reoperation, transfusion, or a decrease of more than 3g/dL hemoglobin was 4.7%, with no difference between groups. Mortality was nil. The average stay was 2.8 days and the outpatient follow-up was 100% during the first 6 months and 95% at 12 months. CONCLUSIONS: The combination of multimodal rehabilitation programs and mechanical and pharmacological thromboprophylaxis by experienced teams, reduces the risk of thromboembolic events and could justify reduced chemoprophylaxis regimens to decrease the risk of postoperative bleeding.

Thrombotic and hemorrhagic risk in bariatric surgery with multimodal rehabilitation programs comparing 2 reduced guidelines for pharmacological prophylaxis. / Riesgo trombótico y hemorrágico en cirugía bariátrica con programas de rehabilitación multimodal comparando 2 pautas reducidas de profilaxis farmacológica.

OBJECTIVE: to determine the thrombotic and hemorrhagic risk in bariatric surgery with multimodal rehabilitation programs, comparing 2guidelines of pharmacological prophylaxis recommended in the Guide to the Spanish Society for Obesity Surgery and the Obesity Section of the AEC. METHODS: Cohorts retrospective study from January-2010 to December-2019. Cases of vertical gastrectomy or gastric bypass were recorded, systematically applying multimodal rehabilitation protocols. Two reduced chemoprophylaxis regimens were analyzed, starting after surgery and maintained for 10 days; one with fondaparinux (Arixtra®) at a fixed dose of 2.5mg / day and the other with enoxaparin (Clexane®) with a single daily dose adjusted to BMI: 40mg / day for BMI of 35-40 and 60mg/day for BMI 40-60. RESULTS: 675 patients were included; 354 with Fondaparinux-Arixtra® during the period 2010-2015 and 321 with Enoxaparin-Clexane® during the period 2016-2019. There were no cases of DVT or clinical PE. However, the incidence of hemorrhage requiring reoperation, transfusion, or a decrease of more than 3g / dL hemoglobin was 4.7%, with no difference between groups. Mortality was nil. The average stay was 2.8 days and the outpatient follow-up was 100% during the first 6 months and 95% at 12 months. CONCLUSIONS: The combination of multimodal rehabilitation programs and mechanical and pharmacological thromboprophylaxis by experienced teams, reduces the risk of thromboembolic events and could justify reduced chemoprophylaxis regimens to decrease the risk of postoperative bleeding.

Insights into the treatment of postsleeve gastrectomy leak: analysis of the results of 105 cases on a national register.

BACKGROUND: Many options have been put forward to treat staple line leaks after sleeve gastrectomy (SG) but no clear consensus has emerged concerning a management algorithm. OBJECTIVES: Aiming to establish a pattern to tailor treatment, the Spanish Society of Obesity Surgery (SECO) and the Obesity Section of the Spanish Association of Surgeons (AEC) set up a national register to record treatment of leaks after SG. SETTING: Multiple hospital centers, Spain. METHODS: Between September 2016 and December 2017, cases were entered into an online database. Results were assessed according to the number and type of therapeutic procedures. RESULTS: One hundred and five patients from 27 centers were diagnosed with postSG leak. The mean age was 44 years, and 77 (73%) were women. Mean body mass index (BMI) was 47 kg/m2. Mortality was 7%. The first treatment was effective in 50% of cases with no significant differences between nonoperative management and surgery. We found no significant correlations between appearance of leak, type of treatment (nonoperative management or surgery), and treatment effectiveness. An endoscopic stent was the first nonoperative option in 30% of cases and second option in 50% of cases, with effectiveness of 61% and 50%, respectively. In patients requiring a third treatment option (n = 25), surgery was more effective than nonoperative treatment (75% versus 8%) and the incidence of complications secondary to endoscopic stent placement was high (71%). CONCLUSION: The choice of postSG leak treatment depends on the patient's clinical condition and the site of the leak. Healing may be slow (>2 months) and may require several interventions using different approaches such as nonoperative treatment, endoscopic stents, or surgery. The effectiveness of endoscopic options decreases and the effectiveness of complex resective or derivative surgery increases with leak duration and the number of treatments required.

The role of endoprostheses in the treatment of leaks after laparoscopic sleeve gastrectomy. Analysis of a Spanish registry. / Papel de las endoprótesis en el tratamiento de las fistulas posgastrectomía vertical laparoscópica. Análisis de un registro nacional.

It has been suggested that endoprostheses are an effective treatment for fistulae after sleeve gastrectomy, but the results published are very variable. To analyze the effectiveness of stents as treatment of leakage after sleeve gastrectomy, the Spanish Society of Obesity Surgery (SECO) and the Obesity Division of the Spanish Association of Surgeons (AEC) set up a National Registry to record treatments of leaks after sleeve gastrectomy. We have analyzed patients with leaks after sleeve gastrectomy and treated with endoprostheses: 19 medical centers reported the use of endoprostheses, where 51 endoprostheses were used in 42 patients (34 women/8 men, mean age: 43.8 years, BMI: 47.6). Global effectiveness was 45%, with a complication rate of 35%. Uni- and multivariate analyses detected no factors influencing the efficacy of treatment. A larger diameter bouggie used to calibrate the stomach was related to a higher incidence of complications. No factors were found related with better stent efficacy. The effectiveness of a second stent was very low when the previous one had not been effective.

Initial Approach to Childhood Obesity in Spain. A Multisociety Expert Panel Assessment.

PURPOSE: In recent years, the incidence of childhood obesity in Europe, and Spain in particular, has increased dramatically. Bariatric surgery could play a major role in treating of adolescents with severe obesity. However, no specific guidelines for bariatric surgery currently exist in Spain. METHODS: The Board of the Spanish Society for Obesity Surgery and Metabolic Diseases (SECO) proposed a study of childhood obesity by using the Delphi method. This prospective study involved 60 experts from nine national societies. Each society leader recruited experts from their society in obesity-related fields. Two online questionnaires were taken, and consensus on guidelines for various obesity treatments was reached according to the percentage of answers in favor or against inclusion of a given guideline. Based on these results, preoperative, surgical management and follow-up of childhood obesity management among others were analyzed. RESULTS: The survey results indicated significant concern among all societies regarding obesity. There was strong consensus with regard to adolescents and obesity, medical treatment, dietary recommendations, environmental and social factors, and goals for adolescents with obesity. Consensus on the use of intragastric balloons and other techniques was not reached. However, biliopancreatic diversion was rejected as a primary treatment, and mandatory psychological/psychiatric assessment was agreed upon. Inclusion criteria accepted were similar to those for adults with the exception of surgery in those with a body mass index <40. CONCLUSIONS: Spanish obesity-related societies are aware of the societal problem of childhood obesity. Multisociety development of national approaches may arise from consensus-building studies among specialists.

Asymmetric dimethylarginine (ADMA) elevation and arginase up-regulation contribute to endothelial dysfunction related to insulin resistance in rats and morbidly obese humans.

KEY POINTS: The presence of insulin resistance (IR) is determinant for endothelial dysfunction associated with obesity. Although recent studies have implicated the involvement of mitochondrial superoxide and inflammation in the defective nitric oxide (NO)-mediated responses and subsequent endothelial dysfunction in IR, other mechanisms could compromise this pathway. In the present study, we assessed the role of asymmetric dimethylarginine (ADMA) and arginase with respect to IR-induced impairment of endothelium-dependent vasodilatation in human morbid obesity and in a non-obese rat model of IR. We show that both increased ADMA and up-regulated arginase are determinant factors in the alteration of the l-arginine/NO pathway associated with IR in both models and also that acute treatment of arteries with arginase inhibitor or with l-arginine significantly alleviate endothelial dysfunction. These results help to expand our knowledge regarding the mechanisms of endothelial dysfunction that are related to obesity and IR and establish potential therapeutic targets for intervention. ABSTRACT: Insulin resistance (IR) is determinant for endothelial dysfunction in human obesity. Although we have previously reported the involvement of mitochondrial superoxide and inflammation, other mechanisms could compromise NO-mediated responses in IR. We evaluated the role of the endogenous NOS inhibitor asymmetric dimethylarginine (ADMA) and arginase with respect to IR-induced impairment of l-arginine/NO-mediated vasodilatation in human morbid obesity and in a non-obese rat model of IR. Bradykinin-induced vasodilatation was evaluated in microarteries derived from insulin-resistant morbidly obese (IR-MO) and non-insulin-resistant MO (NIR-MO) subjects. Defective endothelial vasodilatation in IR-MO was improved by l-arginine supplementation. Increased levels of ADMA were detected in serum and adipose tissue from IR-MO. Serum ADMA positively correlated with IR score and negatively with pD2 for bradykinin. Gene expression determination by RT-PCR revealed not only the decreased expression of ADMA degrading enzyme dimethylarginine dimethylaminohydrolase (DDAH)1/2 in IR-MO microarteries, but also increased expression of arginase-2. Arginase inhibition improved endothelial vasodilatation in IR-MO. Analysis of endothelial vasodilatation in a non-obese IR model (fructose-fed rat) confirmed an elevation of circulating and aortic ADMA concentrations, as well as reduced DDAH aortic content and increased aortic arginase activity in IR. Improvement of endothelial vasodilatation in IR rats by l-arginine supplementation and arginase inhibition provided functional corroboration. These results demonstrate that increased ADMA and up-regulated arginase contribute to endothelial dysfunction as determined by the presence of IR in human obesity, most probably by compromising arginine availability. The results provide novel insights regarding the mechanisms of endothelial dysfunction related to obesity and IR and establish potential therapeutic targets for intervention.

Preserved endothelial function in human obesity in the absence of insulin resistance.

BACKGROUND: Insulin resistance (IR) is frequently associated with endothelial dysfunction and has been proposed to play a major role in cardiovascular disease (CVD). On the other hand, obesity has long been related to IR and increased CVD. However it is not known if IR is a necessary condition for endothelial dysfunction in human obesity, allowing for preserved endothelial function in obese people when absent. Therefore, the purpose of the study was to assess the relationship between IR and endothelial dysfunction in human obesity and the mechanisms involved. METHODS: Twenty non-insulin resistant morbid obese (NIR-MO), 32 insulin resistant morbid obese (IR-MO), and 12 healthy subjects were included. Serum concentrations of glucose, insulin, interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), resistin and adiponectin were determined. IR was evaluated by HOMA-index. Endothelium-dependent relaxation to bradykinin (BK) in mesenteric microvessels was assessed in wire myograph. RESULTS: Serum IL-6, and TNF-α levels were elevated only in IR-MO patients while resistin was elevated and adiponectin reduced in all MO individuals. Mesenteric arteries from IR-MO, but not from NIR-MO subjects displayed blunted relaxation to BK. Vasodilatation was improved in IR-MO arteries by the superoxide scavenger, superoxide dismutase (SOD) or the mitochondrial-targeted SOD mimetic, mito-TEMPO. NADPH oxidase inhibitors (apocynin and VAS2870) and the nitric oxide synthase (NOS) cofactor, tetrahydrobiopterin failed to modify BK-induced vasodilatations. Superoxide generation was higher in vessels from IR-MO subjects and reduced by mito-TEMPO. Blockade of TNF-α with infliximab, but not inhibition of inducible NOS or cyclooxygenase, improved endothelial relaxation and decreased superoxide formation. CONCLUSIONS: Endothelial dysfunction is observed in human morbid obesity only when insulin resistance is present. Mechanisms involved include augmented mitochondrial superoxide generation, and increased systemic inflammation mediated by TNF-α. These findings may explain the different vascular risk of healthy vs unhealthy obesity.

[Is the morbid obesity surgery profitable in times of crisis? A cost-benefit analysis of bariatric surgery]. / ¿Es rentable operar a los obesos mórbidos en tiempos de crisis? Análisis coste-beneficio de la cirugía bariátrica.

Morbid obesity is a serious health problem whose prevalence is increasing. Expensive co-morbidities are associated to these patients, as well as a reduction in the survival. Bariatric surgery resolves the co-morbidities (type 2 diabetes mellitus, 86.6%; cardiovascular risk, 79.0%; obstructive sleep apnea syndrome, 83.6%; hypertension, 61.7%), reduces the mortality rate (among 31-40%), and increases the morbid obese patients survival over a 10-years period. It provides significant savings for the National Health System. The obese patients consume a 20% plus of health resources and 68% plus of drugs than general population. Bariatric surgery requires an initial investment (diagnosis-related group cost: 7,468 €), but it is recovered in a cost-effectiveness ratio of 2.5 years. Significant savings are obtained from the third year. To the direct economic benefits associated with reduced health expenditures it should be added an increase in tax collection (sick leave and unemployment reduction is estimated in 18%, with a productivity increase of 57% for self-employed people). Bariatric surgery is one of the most cost-effective procedures in the healthcare system.

Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry.

BACKGROUND: Reports on laparoscopic sleeve gastrectomy (LSG) communicate very good short-term results on very high-risk morbid obese patients. However, mid- and long-term results are still unknown. A National Registry has been created in Spain to achieve information on the outcomes of this bariatric procedure. METHODS: Data were obtained from 17 centers and collected in a database. Technical issues, preoperative comorbid conditions, hospital stay, early and late complications, and short- and mid-term weight loss were analyzed. RESULTS: Five hundred forty patients were included; 76% were women. Mean BMI was 48.1 +/- 10. Mean age was 44.1 +/- 11.8. Morbidity rate was 5.2% and mortality rate 0.36%. Complications presented more frequently in superobese patients (OR, 2.8 (1.18-6.65)), male (OR, 2.98 (1.26-7.0)), and patients >55 years old (OR, 2.8 (1.14-6.8)). Staple-line reinforcement was related to a lower complication rate (3.7 vs 8.8%; p = 0.039). Mean hospital stay was 4.8 +/- 8.2 days. Mean follow-up was 16.5 +/- 10.6 months (1-73). Mean percent excess BMI loss (EBL) at 3 months was 38.8 +/- 22, 55.6 +/- 8 at 6 months, 68.1 +/- 28 at 12 months, and 72.4 +/- 31 at 24 months. %EBL was superior in patients with lower initial BMI and lower age. Bougie caliber was an inverse predictive factor of %EBL at 12 and 24 months (RR, 23.3 (11.4-35.2)). DM is remitted in 81% of the patients and HTA improved in 63.2% of them. A second-stage surgery was performed in 18 patients (3.2%). CONCLUSIONS: LSG provides good short- and mid-term results with a low morbid-mortality rate. Better results are obtained in younger patients with lowest BMI. Staple-line reinforcement and a thinner bougie are recommended to improve outcome.

Risk of gastrojejunal anastomotic stricture with multifilament and monofilament sutures after hand-sewn laparoscopic gastric bypass: a prospective cohort study.

BACKGROUND: Gastrojejunal (GJ) stricture is one of the most common late complications after laparoscopic Roux-en-Y gastric bypass (LRYGBP) with a hand-sewn anastomosis. The object of this study was to assess the risk of stricture for two types of resorbable suture (multifilament and monofilament) in a series of LRYGBPs performed by the same surgeon. DESIGN: Prospective cohort study. The study population consisted of a series of consecutive morbidly obese patients who underwent primary hand-sewn LRYGBP between March 2004 and May 2008 at the University Hospital in Getafe, Madrid, Spain. The study comprised 242 LRYGBPs with a four-layer continuous hand-sewn anastomosis using absorbable 3/0 gauge suture. The suture material was Ethicon Vicryl multifilament in the first 105 cases and Ethicon Monocryl monofilament in the following 137 cases. All patients were followed up monthly for the first 6 months and then every 6 months after that. RESULTS: The mean BMI was 46 +/- 4 for the multifilament cohort and 48 +/- 6 for the monofilament cohort with no significant difference between the two (p = 0.567). There were no anastomotic leaks, and no cases of marginal ulcer, abscess, abdominal sepsis, deep vein thrombosis, or pulmonary embolism were recorded. No cases required conversion to open surgery, and perioperative mortality was zero. In all, 11 cases of stricture (4.4%) were recorded, 10 in the multifilament suture cohort (9.5%), and only one in the monofilament suture cohort (0.7%; p = 0.001). The odds ratio was 14.3 (95% CI = 1.8-113.4). The mean outpatient follow-up period was 30 months (range = 6-42). CONCLUSIONS: Anastomotic GJ stricture is a common and well-known complication of laparoscopic gastric bypass for morbid obesity. Hand sewing with monofilament suture significantly lowered the frequency of this complication, and hence, monofilament should be the suture material of choice for this suturing technique.

[Gastric bypass and laparoscopic biliopancreatic diversion with manual anastomosis: results in 250 morbidly obese patients]. / Bypass gástrico y derivación biliopancreática laparoscópica efectuadas con anastomosis manual. Resultados en 250 pacientes obesos móbidos.

BACKGROUND: Gastrojejunostomy anastomosis after a gastric bypass or biliopancreatic diversion can be performed by staples or hand-sewn technique. The aim of this study is to analyze totally hand-sewn anastomosis by laparoscopy. METHODS: Morbid obese patients treated consecutively with a gastric bypass or biliopancreatic diversion in which the main anastomosis was performed with a totally hand-sewn gastrojejunostomy by laparoscopy at Hospital Universitario de Getafe from March-01 to November-07. RESULTS: 250 patients were included: 232 were gastric bypass and the remaining 18, biliopancreatic diversion. Mean BMI was 46 +/- 4. There was only one case of digestive bleeding for a marginal ulcer during immediate postoperative period (6th day). Later, there were 2 cases of complicated ulcers: due to bleeding and perforation. There were no anastomotic leaks from the hand-sewn gastrojejunostomy. A patient was re-operated on 48 hours after bypass due to a leak secondary to a thermal perforation at the lesser curvature. Radiological or endoscopic dilatation were required in 11 stenosis (4.4%) at gastrojejunostomy and none in the biliopancreatic diversion group. Mean surgical time for the anastomosis was 40+/-15 minutes. There were no deaths, sepsis, abdominal abscess, deep venous thrombosis or pulmonary embolism. Average hospital stay was 5.1+/-2.4 days. CONCLUSIONS: Even though most surgeons believe that staples anastomosis is easier, hand-sewn technique can be reproducible by surgeons with laparoscopic sutures experience. This technique has a longer operation time but continuous training provides advanced laparoscopic skills and significantly reduces operation time.

Laparoscopic hand-sewn gastrojejunal anastomoses.

BACKGROUND: Reconstruction of the digestive tract during gastric bypass (RYGBP) or biliopancreatic diversion (BPD) involves a mechanical or a hand-sewn gastrojejunal anastomosis. The object of this paper is to assess laparoscopic hand-sewn gastrojejunal anastomoses. METHODS: A series of morbidly obese patients was treated with RYGBP or BPD with a laparoscopic hand-sewn gastrojejunal anastomosis at the Hospital Universitario de Getafe-Madrid (Spain) between March 2001 and November 2007. RESULTS: The series comprised 250 patients, with 232 RYGBPs and 18 BPDs performed. The mean BMI was 46 +/- 4. Only a single case of gastrointestinal hemorrhage (0.4%) was recorded, caused by a marginal ulcer in the early postoperative period (day 6). In the late postoperative period, there were two cases of ulcer (0.8%), one complicated by hemorrhage, the other by perforation. There was no anastomotic leak. One patient (0.4%) required reintervention after 48 h because of thermal perforation of the gastric pouch. There were 11 cases of stenosis (4.4%) requiring radiologically or endoscopically guided dilatation, none in the BPD patients. Mean anastomosis time was 40 +/- 15 min. No cases of mortality or abscess, abdominal sepsis, or thromboembolism were recorded. Mean hospital stay was 5.1 +/- 2.4 days. CONCLUSIONS: Laparoscopic hand-sewn anastomoses are safe and reproducible by surgeons experienced in internal suturing and knot-tying. The technique lengthens operating time, but constant training develops the surgeon's skills, significantly shortening operating time.