1 2 3 Surgery for Obesity and Related Diseases ] (2014) 00–00 4 5 6 Original article 7 8 Single-anastomosis duodenoileal bypass as a second step after sleeve 9 10 gastrectomy 11 a,* b a a 12 Andrés Sánchez-Pernaute , Miguel Ángel Rubio , María Conde , Emmy Arrue , a a 13Q1 Elia Pérez-Aguirre , Antonio Torres 14 aDepartment of Surgery, Hospital Clínico San Carlos, Madrid, Spain 15 bDepartment of Endocrinology, Hospital Clínico San Carlos, Madrid, Spain 16 Received June 20, 2014; accepted June 25, 2014 17 18 19 Abstract Background: After sleeve gastrectomy, many surgical options are available in patients with 20 insufficient weight loss. Duodenal switch is typically considered the operation that results in higher fi 21 weight loss, although it is, perhaps unjustly, considered technically dif cult and may be accom- 22 panied by severe side effects. Single-anastomosis duodenoileal bypass with sleeve gastrectomy is a simplification of the duodenal switch that may behave as a standard biliopancreatic diversion but is 23 easier and quicker to perform. Given its effectiveness as a primary surgery we hypothesized that it 24 would be successful as a second-step operation. The objective of this study was to analyze the 25 weight loss and co-morbidities resolution after a single-anastomosis duodenoileal bypass (SADI) 26 performed as a second step after sleeve gastrectomy. 27 Methods: Sixteen patients with an initial body mass index of 56.4 kg/m2 and a mean excess weight 28 loss of 39.5% after a sleeve gastrectomy were submitted to a single-anastomosis duodenoileal 29 bypass with a 250-cm common channel. 30 Results: There were no postoperative complications. The mean excess weight loss was 72% 2 31 years after the second-step surgery. The complete remission rate was 88% for diabetes, 60% for 32 hypertension, and 40% for dyslipidemia. The mean number of daily bowel movements was 2.1. One 33 patient suffered an isolated episode of clinical hypoalbuminemia. Conclusion: SADI is a safe operation that offers a satisfactory weight loss for patients subjected 34 to a previous sleeve gastrectomy. The side effects are well tolerated, and complications are mini- 35 mal. (Surg Obes Relat Dis 2014;]:00–00.) r 2014 American Society for Metabolic and Bariatric 36 Surgery. All rights reserved. 37 38 39 Keywords: Duodenoileal bypass; Sleeve gastrectomy; Staged surgery; Weight loss 40 41 56 42 57 Sleeve gastrectomy (SG) is a highly effective stand-alone inadequate, or if there is weight regain, different surgical 43 58 surgical procedure for many morbidly obese patients and an options are available as a second step: resleeve, sleeve 44 59 adequate operation as a first step for super-obese (SO) plication, banding of the sleeve, gastric bypass (GB), or 45 60 patients or high-risk patients [1,2]. If weight loss after SG is duodenal switch (BPD-DS) [2]. 46 61 For insufficient weight loss in a patient with a correct 47 62 This work has been partially funded by a grant from the Mutua sleeve anatomy, we usually choose a malabsorptive proce- 48 63 Madrileña. dure, especially if the patient was initially SO, as it offers 49 * 64 Correspondence: Andrés Sánchez-Pernaute, M.D., Ph.D., Esophago- the best weight loss for this subset of patients [3]. Five years 50 gastric, Obesity and Metabolic Surgery Unit, Department of Surgery, 65 ago, we introduced the single-anastomosis duodenoileal 51 Hospital Clínico San Carlos, c/Martín Lago s/n, Madrid 28040, Spain. 66 bypass with sleeve gastrectomy (SADI-S), a modified and 52 E-mail: [email protected]; [email protected] 67 53 http://dx.doi.org/10.1016/j.soard.2014.06.016 68 54 1550-7289/r 2014 American Society for Metabolic and Bariatric Surgery. All rights reserved. 69 55 2 A. Sánchez-Pernaute et al. / Surgery for Obesity and Related Diseases ] (2014) 00–00

70 simplified DS that has demonstrated satisfactory short- and duodenum was separated from the pancreas down to the 125 71 long-term results [4]. After this success, we decided to pancreatoduodenal groove and the gastroduodenal artery. 126 72 introduce single-anastomosis duodenoileal bypass (SADI) After opening the peritoneum at the right margin of the 127 73 as a second step after SG for insufficient weight loss. This duodenum with care not to damage the right gastric artery, 128 74 study was approved by the Hospital Ethical Committee. The the duodenum was encircled and divided with a 60-mm 129 75 study is registered in ClinicalTrials.gov (NCT01685177). blue cartridge linear stapler. The ileocecal junction was 130 76 located, and 250 cm was measured proximally at 10-cm 131 77 Methods intervals. The selected ileal loop was ascended antecolically 132 78 and isoperistaltically anastomosed to the proximal duodenal 133 79 From September 2009 to December 2012, 16 patients, 12 stump with a 30-mm linear stapler and closure of the defect 134 80 female and 4 male, subjected to an initial SG were selected with a 2-layer suture [5] or with a 2-layer running suture 135 81 for SADI as a second-step operation. In this period, 124 hand-sewn anastomosis. The anastomosis was always 136 82 patients had been subjected to SG in our department, 46 covered with a TachoSil sponge (Takeda Pharmaceuticals, 137 83 programmed as a first step, 75 as a stand-alone procedure, Zurich, Switzerland), and a vacuum drain was left behind. 138 84 and in 3 cases the SG was an intraoperative decision for 139 fi 85 technical dif culties. Twenty-nine patients (23%) have been Results 140 86 submitted to a second step. 141 87 Attending to the SADI population, the mean age at the No intra- or postoperative complications were registered. 142 88 time of the sleeve operation was 42 years (18–62), the mean The mean operative time was 114 minutes (45–160), and 143 89 initial weight was 147 kg (99–216), the mean body mass the mean postoperative hospital stay was 5 days (3–7). 144 90 index (BMI) was 56.4 kg/m2 (41–71.5), and the mean excess After discharge, all patients were maintained on a hypo- 145 91 weight was 82 kg (39–140). Nine patients (56%) were caloric diet for 3 to 4 weeks, after which the patients were 146 92 diabetics, 2 of whom were on insulin therapy; 10 patients progressively introduced to a solid diet. Iron (100 mg 147 93 (62%) had hypertension; and 10 (62%) had dyslipidemia. No daily), calcium (calcium citrate, 1200–2000 mg daily), 148 94 intra- or postoperative complications presented after the SG. and a multivitamin complex were also prescribed initially 149 95 Patients were followed in a multidisciplinary basis every 3 to all patients and were continued or discontinued based 150 96 months. A second step was offered if o50% excess weight upon the analytical and clinical results. When necessary, 151 97 loss was achieved, if the patient began to regain the weight vitamin D3, 10,000–30,000 IU/wk was also administrated. 152 98 after reaching an adequate weight nadir, and to every SO All patients were evaluated at 3-month intervals from the 153 99 patient regardless of satisfactory weight loss after the 18th operation. The mean follow-up time was 21 months (2–46). 154 100 postoperative month. SADI was performed as a second step The mean EWL had been 39.5% at the time of the second- 155 101 in all patients without problems derived from the SG, which step operation and became 62.5% (43–80) at 6 months 156 102 could indicate dismantling of the sleeve (severe gastro- after the reoperation, 68.6% (49–83) after 12 months, 73% 157 103 esophageal reflux), and without any accompanying condi- (57–87) after 18 months, and 72% (62.6–81.6) 2 years after 158 2 104 tions contraindicating a malabsorptive operation, such as the SADI (Fig. 1). The mean BMI was 35 kg/m at 2 years F1159 105 liver cirrhosis or inflammatory bowel disease. after the revisional surgery (31.6–37) (Fig. 2). F2160 106 The mean time for the second-step operation was 24 In 8 patients (88.8%), a complete remission of diabetes 161 107 months (16–38) after the initial operation, the mean excess was achieved, with all patients exhibiting values in the 162 108 weight loss (EWL) at the time of the reoperation was 39.5% normal ranges of glycemia and glycated hemoglobin, and 163 109 and the mean BMI was 44 kg/m2 (35.5–55.8). Four patients only 1 patient continuing treatment with 1 daily dose of 164 110 had achieved a EWL 450%. Five patients out of 9 had metformin. Hypertension remitted in 60% of the cases, 165 111 remission of their diabetes after the SG, 4/10 had remission improved in 30%, and remained unchanged in 1 case. 166 112 of hypertension, and 6/10 had remission of dyslipidemia. Dyslipidemia improved in all cases, with absolute normal- 167 113 ization of all parameters in 40% of the cases. 168 114 Technique The mean number of daily bowel movements was 2.1 169 115 (0–5), with only 2 patients reporting 43. 170 116 The first operation was a standard SG performed over a One patient had to be admitted in the first postoperative 171 117 42–54 French gastric bougie. For SADI, patients were year for clinical hypoalbuminemia, which did not recur over 172 118 placed in the supine position with legs closed and the the next 2 years. The analytical data after SG and in the 173 119 surgeon standing at the left-hand side of the patient. second postoperative year after SADI are presented in T1174 120 After a complete evaluation of the abdomen, the distal Table 1. Table 2 summarizes oral supplements taken by T2175 121 end of the previous sleeve was identified, and with the the patients before and after SADI. 176 122 stomach held upwards, dissection of the greater curvature Up to now, no patient has presented signs of intestinal 177 123 was completed through the first segment of the duodenum, obstruction and no patient has been reoperated for an 178 124 2- or 3-cm distal to the pylorus. The posterior wall of the internal hernia. 179 One-loop Duodenal Switch after SG / Surgery for Obesity and Related Diseases ] (2014) 00–00 3

180 235 181 236 182 237 183 238 184 239 185 240 186 241 187 242 188 243 189 244 190 245 191 246 192 247 193 248 194 249 195 250 196 251 197 252 198 Fig. 1. The excess weight loss (EWL) percentage of the entire series with the sleeve procedure, the nadir reached after the sleeve procedure, and the 253 199 progression of the EWL percentage after the second step operation. Means are expressed in the upper box. 254 200 255 201 Discussion SADI-S is a simplified BPD-DS, and since we introduced 256 202 it in 2007, SADI-S seems to achieve similar results as the 257 The present work reports our initial experience with 203 original BPD-DS [6]. Current measurement of the efferent 258 SADI, a one-loop duodenal switch with a 250-cm common 204 loop is 250 cm, which is similar to the alimentary limb of 259 limb, as a second step for patients with a previous sleeve 205 BPD-DS [4]. The unification of the alimentary and the 260 gastrectomy. Our results demonstrate good definitive weight 206 common limb in a single loop apparently has no negative 261 loss after the second procedure, increasing from an initial 207 effect on weight loss, and the reduction to 1 anastomosis 262 39.5% EWL after the sleeve procedure to a final 72% EWL 208 saves operative time and reduces the probability of post- 263 after the duodenal bypass, with all patients losing 450% of 209 operative complications. These principles were applied to 264 their initial excess weight. This number is of particular 210 introduce SADI as a second step after a failed SG. 265 importance because the initial mean BMI of the present 211 It is a matter of controversy which operation should be 266 series was over 56 kg/m2, and 75% of the patients were 212 performed as a second step after an SG. Many different 267 initially SO patients. Co-morbidities were successfully 213 techniques are available. It is possible to repeat the SG if 268 controlled after the second operation. 214 any part of the stomach is dilated, as first proposed by 269 215 270 216 271 217 272 218 273 219 274 220 275 221 276 222 277 223 278 224 279 225 280 226 281 227 282 228 283 229 284 230 285 231 286 232 287 233 288 234 Fig. 2. Body mass index evolution of the entire series before and after the second-step operation. Means are expressed in the upper box. 289 4 A. Sánchez-Pernaute et al. / Surgery for Obesity and Related Diseases ] (2014) 00–00

290 Table 1 345 291 Nutritional values after sleeve and after single-anastomosis duodenoileal bypass 346 292 Postsleeve Post-SADI 347 293 348 Mean (SD) Range % Abnormal Mean (SD) Range % Abnormal 294 349 295 Iron (mg/mL) 78.7 (33.0) 42–156 0 66.5 (26.1) 30–104 50 350 – – 296 Vitamin B12 (pg/mL) 357 (126) 158 554 6 414.5 (295.6) 172 1294 6 351 Folic acid (ng/mL) 6.5 (5.06) 2.03–20.3 12 6.0 (2.9) 2.0–11.3 6 297 Vitamin D (ng/mL) 23.1 (15.1) 9.7–59.8 Deficiency 6 17.2 (12.7) 3.9–53.7 Deficiency 6 352 298 Insufficiency 50 Insufficiency 50 353 299 Parathormone (pg/mL) 69.4 (31.8) 16.6–113 25 72.4 (38.1) 28.9–155 25 354 300 Albumin (g/dL) 4.1 (0.2) 3.6–4.5 0 4 (.2) 3.7–4.3 0 355 – – 301 Proteins (g/dL) 7.1 (0.4) 6.3 7.7 6 6.7 (.3) 6.2 7.4 18 356 Copper (mg/mL) 125.8 (13.2) 109–146 0 95.4 (20.6) 59–124 12 302 Selenium (mg/mL) 79.3 (7.9) 109–146 0 60.6 (18.1) 35–96 50 357 303 Zinc (mg/mL) 84 (9.5) 65–95 0 67.9 (11.9) 54–88 31 358 304 Vitamin A (mg/L) .4 (0.1) .3–.5 0 .3 (.1) .2–.6 25 359 305 Vitamin E (mg/L) 12.9 (2.3) 10.7–16 0 9.6 (2.5) 6.2–15 0 360 306 SADI ¼ single-anastomosis duodenoileal bypass; SD ¼ standard deviation. 361 307 362 308 Gagner and Rogula [7] for insufficient weight loss after a also been reported after standard GB [16,17]. On the other 363 309 BPD-DS and later by Baltasar et al. [8] as a revisional hand, the rates of co-morbidities resolution, especially type 364 310 operation for a failed SG. Plication or banding of the sleeve 2 diabetes mellitus, were more than satisfactory. 365 311 are other possibilities that try to reduce complications BPD-DS has been traditionally considered a difficult 366 312 associated with the procedure, and GB is likely the most operation to perform, with more frequent postoperative 367 313 used surgical option [9–11]. However, there are few papers complications. In our hands this is not true, as the post- 368 314 reporting the results of GB performed as a second step; it operative evolution of our patients does not differ from that 369 315 may be that the results are similar to those obtained after after GB. Highly experienced groups have also reported this 370 316 GB was performed as an initial operation. Gautier et al. [11] for the traditional BPD-DS [18]. However, we believe that 371 317 reported 61.7% EWL at 15 months after the second step, it is very important to stage the procedure, as recommended 372 318 whereas Alexandrou et al. [10] reported a 71.9% long-term by Gagner and DeMaria et al. [9,19], which may have Q3373 319 EWL for a series of SO patients with an initial mean BMI of resulted in the good postoperative outcomes in our study. 374 320 59 kg/m2 and a final BMI of 33.6 kg/m2. In our opinion, Staging of the procedure has the additional advantage to 375 321 these results are very positive and quite similar to those offer some patients the possibility of avoiding the second 376 322 obtained by our group. Other groups report more discrete step, what can happen in as much as 73% of the cases, as 377 323 results after converting SG into GB and even note that reported by Ianelli et al. [20]; in our experience 54% of the 378 324 patients who regain weight after SG could be regain weight SO patients do not require duodenal diversion after SG. 379 325 after GB [12]. BPD-DS was the initial option for a second Technically, BPD-DS exhibits some advantages over other 380 326 step after SG, as SG was born as the staging of BPD-DS. techniques as a second step after SG; the operation is direc- 381 327 BPD-DS has also been the recommendation of many ted toward a “nontouched” area, the duodenum, and this 382 328 surgeons because most of the patients completing the simplifies dissection and decreases anastomotic problems. 383 329 second stage after SG had initially been SO patients, and This has been recently stated by Dapri et al. [21], which 384 330 BPD-DS and BPD-like operations exhibit better long-term demonstrate a similar rate of postoperative complications 385 331 results in this subset. Sovik et al. [13] observed a 26% 386 332 failure rate after GB versus a 0% after BPD-DS, and 387 Prachand et al. [3] reported a 40% failure rate after GB in Table 2 333 Percentage and number (parenthesis) of patients taking supplements after 388 334 SO patients and a 16% failure rate after BPD-DS. None- sleeve gastrectomy and after single-anastomosis duodenoileal bypass 389 335 theless, the secondary effects associated with BPD and 390 Supplements Postsleeve Post-SADI 336 BPD-DS may sometimes, in some authors’ opinions, out- 391 337 weigh the beneficial weight loss of malabsorptive surgery No supplements 43% (7) 0% 392 338 [13,14]. Problems secondary to malabsorptive surgery have Multivitamins 43% (7) 68.7% (11) 393 Iron 37.5% (6) 68.7% (11) 339 likely been exaggerated, as when exhaustive comparisons þ 394 fi Calcium vitamin D 43% (7) 68.7% (11) 340 between GB and BPD-DS are performed, signi cant differ- Extra vitamin D 6% (1) 43% (7) 395 341 ences are only observed in serum calcium levels and bowel Vitamin B12 6% (1) 6% (1) 396 342 movements [15]. In our series, decreased levels of vitamin Folic acid 6% (1) 6% (1) 397 þ 343 D, iron, and some micronutrients (selenium and zinc) were Vitamin A E 6% (1) 18.7% (3) 398 344 detected, but these abnormalities were not severe and have SADI ¼ single-anastomosis duodenoileal bypass. 399 One-loop Duodenal Switch after SG / Surgery for Obesity and Related Diseases ] (2014) 00–00 5

400 between BPD-DS and resleeve gastrectomy as second step; [5] Sánchez-Pernaute A, Pérez-Aguirre E, Díez-Valladares L, et al. 446 401 in addition, complications after BPD-DS are easier to “Right-angled” stapled latero-lateral duodeno-jejunal anastomosis in 447 402 manage than those affecting the higher part of the gastric the duodenal switch. Obes Surg 2005;15:700–2. 448 [6] Hess DS. Biliopancreatic diversion with duodenal switch. Surg Obes 403 staple line. Furthermore, our technique with reduction to 1 449 Relat Dis 2005;1:329–33. 404 anastomosis helps in this reduction of potential postoper- [7] Gagner M, Rogula T. Laparoscopic reoperative sleeve gastrectomy 450 405 ative short- and long-term complications. The elimination of for poor weight loss after biliopancreatic diversion with duodenal 451 406 the mesenteric defect reduces the probability of internal switch. Obes Surg 2003;13:649–54. 452 407 herniation; there remains a huge defect below the ascended [8] Baltasar A, Serra C, Pérez N, et al. Re-sleeve gastrectomy. Obes Surg 453 – 408 ileal loop, which could act as a hernia ring provoking 2006;16:1535 8. 454 [9] Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with 409 obstruction or even volvulation of the small bowel along the two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in 455 410 anastomotic loop axis, but up to now, no patient has the super-super obese patient. Obes Surg 2003;13:861–4. 456 411 presented with signs of intestinal obstruction yet. [10] Alexandrou A, Felekouras E, Giannopoulos A, Tsigris C, Diamantis T. 457 412 The present results have to be analyzed with caution. The What is the actual fate of the super-morbid-obese patients who undergo 458 413 main limitation of the study is the absence of randomization; laparoscopic sleeve gastrectomy as the first step of a two-stage weight- 459 – 414 patients included are mostly those who have failed to an reduction operative strategy? Obes Surg 2012;22:1623 8. 460 [11] Gautier T, Sarcher T, Contival N, Le Roux Y, Alves A. Indications 415 initial SG, so they should be considered to be to some extent and mid-term results of conversion from sleeve gastrectomy to Roux- 461 416 resistant to bariatric surgery. Long-term follow-up is also en-Y gastric bypass. Obes Surg 2013;23:212–5. 462 417 necessary to know if results are maintained and if compli- [12] Langer FB, Bohdjalian A, Shakeri-Leidenmühler S, Schoppmann SF, 463 418 cations do not out outweigh weight loss results. Comparison Zacherl J, Prager G. Conversion from sleeve gastrectomy to Roux- 464 419 with other technical options as resleeve, plication, or gastric en-Y gastric bypass - indications and outcome. Obes Surg 2010;20: 465 – bypass is recommended to draw out definite conclusions. 835 40. 420 [13] Sovik TT, Taha O, Aasheim ET, et al. Randomized clinical trial of 466 421 laparoscopic gastric bypass versus laparoscopic duodenal switch for 467 422 Conclusion superobesity. Brit J Surg 2010;97:160–6. 468 423 [14] Sovik TT, Aasheim ET, Taha O, et al. Weight loss, cardiovascular 469 SADI offers a satisfactory weight loss for those patients 424 risk factors, and quality of life after gastric bypass and duodenal 470 submitted previously to a SG. It is a simplified technique, – 425 switch. A randomized trial. Ann Intern Med 2011;155:281 91. 471 with a low postoperative complication rate and an accept- [15] Laurenis A, Taha O, Maleckas A, Lönroth H, Olbers T. Laparoscopic 426 472 able rate of nutritional deficiencies, and should be consid- biliopancreatic diversion/duodenal switch or laparoscopic Roux-en-Y 427 473 ered as a good option as a second step after SG. gastric bypass for super-obesity - weight loss versus side effects. Surg 428 Obes Relat Dis 2010;6:408–16. 474 429 [16] Higa K, Ho T, Tercero F, Yunus T, Boone KB. Laparoscopic Roux- 475 Q4 Disclosures 430 en-Y gastric bypass: 10-year follow-up. Surg Obes Relat Dis 2011;7: 476 – 431 516 25. 477 The authors have no commercial associations that might [17] John S, Hoegerl C. Nutritional deficiencies after gastric bypass 432 be a conflict of interest in relation to this article. surgery. J Am Osteopath Assoc 2009;109:601–4. 478 433 [18] Biertho L, Lebel S, Marceau S, et al. Perioperative complications in a 479 434 References consecutive series of 1000 duodenal switches. Surg Obes Relat Dis 480 435 2013;9:63–8. 481 436 [1] Himpens J, Dobbeleir J, Peeters G. 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