Surg Endosc DOI 10.1007/s00464-015-4157-2
and Other Interventional Techniques
Laparoscopic mini-gastric bypass in patients age 60 and older Cesare Peraglie1
Received: 13 August 2014 / Accepted: 8 March 2015 Ó Springer Science+Business Media New York 2015
Abstract Background Bariatric surgery in patients over age 60 was previously not considered, due to higher risk. The author presents a study of patients C60 years who underwent laparoscopic mini-gastric bypass (LMGB), to evaluate outcomes with follow-up to 6 years. Methods From 2007–2013, a prospectively maintained database was reviewed and patients C60 years were identified. Demographics evaluated included age, sex, weight, BMI, comorbidities, operative time, complications, length of stay (LOS) and %EWL up to 72 months. Results From 2007–2013, a total of 758 LMGBs were performed by one surgeon (CP). Eighty-eight (12 %) were C60 years old, with 62 % female. Mean age of this cohort at operation was 64 (60–74), and mean weight and BMI were 118 kg (78–171) and 43 kg/m2 (33–61), respectively. Comorbidities were present in all patients, and one-third had previous abdominal operations. All patients underwent LMGB, without conversion to open. Mean operative time was 70 min (43–173). Only one patient required overnight ICU admission. Average LOS was 1.2 days (1–3). Overall complication rate was 4.5 % (all minor); there were no major complications. Readmission rate was 1.2 % (one patient). There was no surgical-related mortality. Followup to 90 days was 89 %, but steadily declined to 42 % at 6 years (72 months). The %EWL was 72 % at 72 months. Conclusion LMGB can be safely performed with good weight loss in patients C60 years old, despite numerous comorbidities and previous abdominal operations. & Cesare Peraglie [email protected] 1
Heart of Florida Regional Medical Center, 40124 Highway 27, Suite 203, Davenport, FL 33837, USA
Keywords Laparoscopic Bariatric surgery Minigastric bypass Medicare
Obesity is now a pandemic affecting people of all ages. While most of the focus has been on therapy for middle-age patients, since 1990 the prevalence of obesity has increased more than 50 % in the elderly [1]. As the population continues to age, the proportion of patients C60 years with obesity has reached *25 % [2]. In 2006, the Centers for Medicare and Medicaid Services established a National Coverage Determination, having found that bariatric surgery is safe and effective in the covered population but that data in the elderly population were lacking. Because of increased comorbidities with age, elderly patients pose a greater surgical risk of morbidity and mortality [3, 4], and there was a warning against bariatric surgery for patients [65 years of age [5]. Recently, however, numerous authors have published studies on the safety and efficacy of bariatric operations in this patient population [2, 6–10]. The laparoscopic mini-gastric bypass (LMGB), also known as the one-anastomosis or omega-loop gastric bypass, was devised 16 years ago by Dr. Robert Rutledge [11, 12] and has been adopted progressively by bariatric surgeons [13–22], as a safe, rapid and effective procedure. After performing various bariatric operations, the author was trained in the LMGBP by Dr. Rutledge and has been conferring with the other LMGBP surgeons worldwide, especially at the annual Paris LMGB Consensus Conferences. Papers have been published showing superiority of the LMGBP to the Roux-en-Y gastric bypass (RYGBP) and the sleeve gastrectomy (SG) [23–32]. We present a study of the LMGB in patients C60 years who have been evaluated with respect to outcomes from the perioperative period up to 6 years postoperatively.
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Materials and methods From 2007 to 2013, all patients who had LMGB were entered prospectively into a database that was then retrospectively reviewed to identify all patients age C60 years. Preoperatively, all patients were required to undergo a multi-step program that included extensive education on the procedure as well as potential risks and complications. Patients were also required to have medical and psychological clearance, laboratory evaluation including H. pylori testing, complete blood count (CBC), comprehensive metabolic panel (CMP) and vitamin D levels. In the event of H. pylori positivity or low vitamin D, treatment for eradication or vitamin D supplementation was given prior to surgery. All patients were seen one-on-one by the surgeon (CP), and all attended an extensive group clinic before surgery, where patients and family were exposed to another educational session and again encouraged to ask questions. The technique of LMGB (Fig. 1) has been previously well described [11, 12, 17, 19]. All patients had sequential compression devices and elastic stockings placed prior to induction of anesthesia, and no pharmacologic anticoagulation was utilized. Intravenous antibiotics were administered within 1 h before skin incision. All patients were placed in the supine position, with pillows and eggcrate foam to protect against compression injuries. Five trocars were used in most cases (two 12 mm, two 10 mm
and one 5 mm). Creation of the long pouch was begun by stapling at the area of the crow’s foot (just below the incisura) and continued parallel to the lesser curve with sequential firings to the angle of His (which was not dissected), alongside a 28F bougie. Staple-line reinforcement was not performed unless clinically indicated. The length of small bowel bypassed distal to Treitz’ ligament was selected according to the BMI and amount of excess weight [33]; most common length was 180 cm. The anastomosis was then performed side-to-side with an endo-GIA. It was closed with another firing of the stapler and oversewn with a circumferential running suture. Postoperatively, all patients were admitted to a standard postsurgical floor, and no urinary or nasogastric intubation was utilized. At time of discharge, patients were required to remain within 1 h of driving distance from the hospital for 1 week and to contact the surgeon daily. At 1 week, patients were seen in the office for the first postoperative checkup, and they were given an additional information session as well as forms for their primary care physician and for follow-up. Patients were followed up at 1 month and then every 3 months for the first 2 years. Follow-up is typically done in the office by the operating surgeon face-to-face. In the event that patients are unable to return to the office, they are required to maintain the same schedule with their primary care physician (PCP), but must also send us the follow-up forms (provided to them at the 1-week visit) as well as copies of the PCP notes. Laboratory testing was done every 6 months for the first 2 years and then yearly. These include CBC, CMP, water and fat-soluble vitamin levels, iron studies, parathyroid hormone (PTH) and HbA1c if diabetic, with supplements adjusted as necessary. Salicylates, smoking, alcohol and soda consumption were forbidden. Routine empiric endoscopy was not done as there is no indication for surveillance of B2 gastrojejunostomies that has been established in the surgical literature. Any patients who subsequently develop symptoms such as pain or bilious vomiting are first questioned regarding smoking and dietary choices. Patients are then managed for acid reflux and if no improvement then studied typically with upper endoscopy and on occasion upper contrast studies. If patients did not follow up, they were contacted by phone and e-mail. If they do not respond, we then send a letter by regular mail.
Results
Fig. 1 Laparoscopic mini-gastric bypass. A long mildly restricting but non-obstructing gastric conduit is anastomosed in easy view antecolic to the jejunal loop, providing malabsorption
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From 2007–2013, a total of 758 patients underwent LMGB. On review of the database, 88 (12 %) were age C60, with 62 % female and 38 % male. Average age at operation was 64 years (60–74), and average weight and BMI were 118 kg (78–171) and 43 kg/m2 (33–61), respectively. (The one patient with BMI \ 35 had had a previous
Surg Endosc
abdominoplasty and had medically refractory diabetes. Postoperatively, she has done very well.) Patients had multiple comorbidities (Table 1), and more than one-third had had previous abdominal surgery (Table 2). All patients underwent the LMGB, and there were no conversions to open. Average operative time was 71 min (43–173). One patient suffered a capsular tear of the spleen, and another had bleeding from the splenic hilum; both were managed with packing and observation. No patient required transfusion, splenectomy or conversion to open laparotomy. Postoperatively, the patients were transferred to a standard postsurgical floor on telemetry. One patient, while in the recovery room, required temporary re-intubation and was observed overnight in the ICU and then transferred to the surgical floor the following morning. Average length of stay (LOS) was 1.2 days (1–3). Only one patient required readmission for 23-h observation due to a bleeding portsite while at home; this was managed by simple suture ligation of the wound at the bedside, and the patient was discharged the following morning. The overall complication rate was 4.5 % (4 patients), and these were all minor (Table 3). There were no cases of wound infection, anastomotic stricture requiring dilatation or internal hernia in
this cohort. There was no surgical mortality in the entire group. One patient was deceased 2 years postoperatively from an anaplastic carcinoma of the thyroid, and one patient was diagnosed with a breast carcinoma 3 years postoperatively. Both patients had maintained follow-up [1 year and were doing well prior to their cancer. After 1 year, resolution of diabetes occurred in 84 % of diabetics and hypertension resolved in 76 % of hypertensives. There has been no bile reflux or marginal ulcer occurrences noted to date. One patient from out of state, however, was lost to follow-up at 9 months. Apparently, this patient suffered a myocardial infarction at 18 months post-op, and according to a family member, he was converted to RYGB for unknown reason. The situation was very unclear, and we were unable to get any return calls from patient or his physicians. Follow-up at 90 days was 89 %. Patients have been followed and evaluated up to 72 months. Despite numerous attempts to contact patients, many had changed their e-mail address, telephone numbers and even city of residence. Table 4 shows the follow-up rates and %EWL for the corresponding time-periods.
Table 3 Complications Complication
Table 1 Patient comorbidities Comorbidity
Patients (%)
Hypertension
67 (76 %)
Diabetes type 2
40 (45 %)
Dyslipidemia
36 (41 %)
DM/HTN/lipida
20 (23 %)
CADb
10 (11 %)
Coronary stents
6 (7 %)
Plavix/Coumadin
6 (7 %)
a
DM/HTN/lipid = diabetes, hypertension, dyslipidemia in the same patient b
CAD coronary artery disease
Patients (%)
Bleeding port-site
2 (2)
Reintubation
1 (1)
Readmission Oral thrush
1 (1) 1 (1)
Mortality—in hospital
0
Mortality—30 days
0
Mortality—90 days
0
Leak
0
DVT/PE
0
Transfusion
0
Reoperation
0
Table 4 Follow-up and %EWL Table 2 Previous abdominal operations Previous surgery
Patients (%)
Total abdominal hysterectomy
14 (16 %)
Ventral hernia repair with mesh
13 (15 %)
Open cholecystectomy Laparoscopic cholecystectomy
13 (15 %) 7 (8 %)
Time period (months)
Follow-up (%)
%EWL (%)
1
95
18
6
80
52
12 24
77 66
67 70
36
59
68
Abdominal lipectomy
5 (6 %)
48
51
66
Exploratory laparotomy
2 (3 %)
60
45
67
Colon resection
1 (2 %)
72
42
72
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Discussion There was initial skepticism of the LMGB, because it was mistaken by many to be similar to the Mason horizontal loop gastric bypass [34] where bile reflux adjacent to the esophagus had the potential to be problematic. Furthermore, there was a lack of understanding of the development of neoplasia in studies of bile in the rodent stomach. Indeed, after the Billroth II operation used for peptic ulcer and cancer for the past 100 years, studies for the development of carcinoma found a decreased incidence [35–38], even though H. pylori was not known or treated then. Furthermore, with bile insertion studies in the rodent stomach, Frantz and others [39, 40] showed that hyperplasia and neoplasia occurred in the proximal two-thirds of the unique rat’s stomach (which is squamous cell) but not in the distal glandular third (which corresponds to the human stomach). Although after the other bariatric operations [41–44], 44 cases of cancer have been reported, no case of carcinoma in the gastric pouch or esophagus has been reported after the LMGB, which has a long lesser curvature gastric pouch. After the thousands of vagotomy and pyloroplasties of the 1960s and 1970s for peptic ulcer (with bile in the distal stomach), gastric cancer did not develop. Thus, fear of gastric cancer after the LMGB is not borne out. The author (CP) has performed more than 1200 LMGBs since 2004, with fortunately no operative mortality. However, the role of bariatric surgery in patients C60 years old is unclear regarding safety and efficacy [5–10] and was the purpose of our study. With the rising incidence of this agegroup combined with the epidemic of obesity, the rate of bariatric operations in patients C60 is increasing. Printen and Mason [45] in 1977 described an 8 % 30-day mortality after bariatric surgery for patients [50 years of age. This was represented in the NIH Consensus Statement
that regarded age [50 as a potential contraindication to bariatric surgery [45]. Flum et al. [3] reported higher complication rates in patients [65 years of age, citing a 4.8 % 30-day and a 6.9 % 90-day mortality, and an 11.1 % mortality at 1 year. Moreover, they noted that the odds of death within 90 days were fivefold higher for older Medicare beneficiaries. Subsequently, Livingston et al. [5] reported a mortality rate that was three times higher in patients[55 than in younger patients. Despite these findings, in February 2006, the Centers for Medicare and Medicaid Services issued a National Coverage Determination, and the Medicare Advisory Committee found bariatric surgery to be safe and effective in the covered population, but noted that data on the elderly were limited. Our study represents a cohort of patients who were age C60 years who presented with significant comorbidities as well as operative challenges due to previous abdominal procedures. In reviewing the data on outcomes, our results are in line with those of gastric bypass procedures in this patient population (Table 5). Our data, however, has limitations. Despite aggressive attempts to contact patients and preoperative instruction, decreasing follow-up to 6 years showed difficulty in maintaining complete follow-up. Many of our patients are from out of state, and we were unable with time to see some of these patients in actual face-to-face encounters. In many situations, we had to rely on forms that were faxed, e-mailed, telephoned or followed up correspondence from primary care physicians. This loss of patient follow-up is consistent with other studies that look at long-term outcome. Follow-up rates in these studies ranged from 24 to 48.9 % [46–49]. Despite this, we believe that our results with the LMGB are favorable and comparable to recent reported series with respect to patient demographics, complications, mortality
Table 5 Gastric bypass in patients 60 ? years old Peraglie (current study)
O’Keefe [6]
Willkomm [2]
Wittgrove [7]
Dunkle-Batter [8]
Nelson [9]
Quebbeman [10]
Number of patients (n)
88
157
100
120
61
25
13
Age mean (range)
64 (60–74)
67 (65–78)
68 (65–77)
63 (60–74)
62 (60–72)
68
68 (65–73)
BMI (kg/m2)
43 (33–61)
48 (35–73)
45 (33–61)
45 (34–70)
49 (38–78)
50
45.8 ± 8.6
Laparoscopic
100 %
97 %
100
100 %
34 %
32 %
LOS days (mean)
1.2
2 (0–18)
1.97
Not stated
2.9
7±3
1.9
Complication
4.5 % (all minor)
NA
19 %
7.7 %
0
NA
1.7 %
16.9 (major to 90 days) 3.3 %
20 %
Re-operation
7 % (major)/33 % (minor) 2.5 %
4%
0
Mortality-total
0
1.35 % (1 year)
0 (30 days)
0
1.64
4%
0
30 days re-admit
1.2 % (1)
Not stated
6%
Not stated
Not stated
0
0
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and weight loss (Table 5). Long-term studies have shown that the LMGB results in a very favorable reduction in type 2 diabetes, hypertension and other comorbidities, compared with other bariatric operations [24–26, 30, 31].
Conclusion LMGB is a technically simple and safe procedure that offers the advantage of being fully reversible and revisable in a laparoscopic fashion. Despite what has been considered a higher-risk population with multiple comorbidities, outcomes were favorable with a low complication rate, no mortalities and favorable weight loss. Although follow-up was short and attrition was noted, the results are promising. Further study in patients C60 years of age with longer follow-up and attempted more rigid follow-up is contemplated. Acknowledgments The author is grateful to Mervyn Deitel, MD, FASMBS, FACN, CRCSC for suggestions with the study and manuscript. Disclosures Cesare Peraglie has no conflicts of interest or financial ties to disclose.
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11. Rutledge R, Walsh TR (2005) Continued excellent results with the mini-gastric bypass: six year study in 2,410 patients. Obes Surg 15:1304–1308 12. Rutledge R (2001) The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg 11:276–280 13. Garcia-Caballero M, Carbalo M (2004) One anastomosis gastric bypass: a simple, safe and efficient procedure for treating morbid obesity. Nutr Hosp 19:372–375 14. Carbajo M, Garcia-Caballero M, Toledano M, Osorio D, GaraciaLanza C, Carmona JA (2005) One-anastomosis gastric bypass by laparoscopy: results of the first 209 patients. Obes Surg 15:398–404 15. Noun R, Riachi E, Zeidan S, Abboud B, Chalhoub V, Yazigi A (2007) Mini-gastric bypass by mini-laparotomy: a cost-effective alternative in the laparoscopic era. Obes Surg 17:1482–1486 16. Chakhtoura G, Zinzindohou F, Ghanem Y, Ruseykin I, Dutranoy JC, Chevallier JM (2008) Primary results of laparoscopic minigastric bypass in a French obesity-surgery specialized university hospital. Obes Surg 18:1130–1133 17. Peraglie C (2008) Laparoscopic minigastric bypass (LMGB) in the super–super obese: outcomes in 16 patients. Obes Surg 18:1126–1129 18. Peraglie C (2007) Mini-gastric bypass in a patient homozygous for Factor V Leiden. Obes Surg 17:104–107 19. Chevallier J-M, Chakhtoura G, Zinzindohoue F (2010) Laparoscopic mini-gastric bypass. In: Deitel M, Gagner M, Dixon JB, Himpens J (eds) Handbook of obesity surgery. F-D Communications, Toronto, pp 78–84. www.HandbookofObesitySurgery. com 20. Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M (2012) One thousand consecutive mini-gastric bypass: short and longterm outcome. Obes Surg 22:697–703 21. Piazza L, Ferrara F, Leanza S, Coco D, Sarva` S, Bellia A, Di Stefano C, Basile F, Biondi A (2011) Laparoscopic mini-gastric bypass: short-term single-institute experience. Updates Surg 63:239–242 22. Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT (2005) Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg 242:20–28 23. Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC (2012) Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg 22:1827–1834 24. Garcia-Caballero M, Valle M, Martinez-Moreno JM et al (2012) Resolution of diabetes mellitus and metabolic syndrome in normal weight 24–29 BMI patients with one anastomosis gastric bypass. Nutr Hosp 27:623–631 25. Milone M, Di Minno MN, Leongito M, Maietta P, Bianco P, Taffuri C, Gaudioso D, Lupoli R, Savastano S, Milone F, Musella M (2013) Bariatric surgery and diabetes remission: sleeve gastrectomy or mini-gastric bypass? World J Gastroenterol 19:6590–6597 26. Moszkowicz D, Rau C, Guennzi M, Zinzindohoue F, Berger A, Chevallier JM (2013) Laparoscopic omega-loop gastric bypass for the conversion of failed sleeve gastrectomy: early experience. J Vis Surg 150:373–378 27. Musella M, Sousa A, Greco F, Luca De, Manno E, Di Stefano C, Milone M, Bonfanto R, Segato G, Antonino A, Piazzo L (2014) The laparoscopic mini-gastric bypass: the Italian experience: outcomes from 974 consecutive cases in a multi-center review. Surg Endosc 28:156–163 28. Kular KS, Manchanda N, Rutledge R (2014) A 6-year experience with 1,054 mini-gastric bypasses—first study from Indian subcontinent. Obes Surg. doi:10.1007/s11695-014-1220-3
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40. Proctor DM, Gatto NM, Hong SJ et al (2007) Mode-of-action framework for evaluating the relevance of rodent forestomach tumors in cancer risk assessment. Toxicol Sci 98(2):313–326. doi:10.1093/toxsci/kfm075 41. Scozzari G, Trapani R, Toppino M, Morino M (2013) Esophagogastric cancer after bariatric surgery: systematic review of the literature. Surg Obes Relat Dis 9:133–142 42. Nau P, Rattner DW, Meireles O (2014) Linitus plastica presenting two years after elective Roux-en-Y gastric bypass for treatment of morbid obesity: a case report and review of the literature. Surg Obes Relat Dis 10(2):e15–e17 43. Scheepers AF, Schoon EJ, Nienhuijs SW (2011) Esophageal cancer after sleeve gastrectomy. Surg Obes Relat Dis 7(4):e11– e12 44. Angrisani L, Santonicola A, Iovino P (2014) Gastric cancer: a de novo diagnosis after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis 10(1):186–187 45. Printen KJ, Mason EE (1977) Gastric bypass for morbid obesity in patients more than fifty years of age. Surg Gynecol Obstet 144:192–194 46. Diamantis T, Konstantinos G, Apostolou G et al (2014) Review of long term weight loss results after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis 10:177–183 47. Obeid A, Long J, Kakade M et al (2012) Laparoscopic Roux-enY gastric bypass: long term clinical outcomes. Surg Endosc 26:3515–3520 48. Skroubis G, Karamanakos S, Sakellaropoulos G et al (2011) Comparison of early and late complications after various bariatric procedures: incidence and treatment during 15 years at a single institution. World J Surg 35:93–101 49. Higa K, Ho T, Tercero F, Yunus T, Boone KB (2011) Laparoscopic Roux-en-Y gastric bypass: 10-year follow-up. Surg Obes Relat Dis 7:516–525
and Other Interventional Techniques
Laparoscopic mini-gastric bypass in patients age 60 and older Cesare Peraglie1
Received: 13 August 2014 / Accepted: 8 March 2015 Ó Springer Science+Business Media New York 2015
Abstract Background Bariatric surgery in patients over age 60 was previously not considered, due to higher risk. The author presents a study of patients C60 years who underwent laparoscopic mini-gastric bypass (LMGB), to evaluate outcomes with follow-up to 6 years. Methods From 2007–2013, a prospectively maintained database was reviewed and patients C60 years were identified. Demographics evaluated included age, sex, weight, BMI, comorbidities, operative time, complications, length of stay (LOS) and %EWL up to 72 months. Results From 2007–2013, a total of 758 LMGBs were performed by one surgeon (CP). Eighty-eight (12 %) were C60 years old, with 62 % female. Mean age of this cohort at operation was 64 (60–74), and mean weight and BMI were 118 kg (78–171) and 43 kg/m2 (33–61), respectively. Comorbidities were present in all patients, and one-third had previous abdominal operations. All patients underwent LMGB, without conversion to open. Mean operative time was 70 min (43–173). Only one patient required overnight ICU admission. Average LOS was 1.2 days (1–3). Overall complication rate was 4.5 % (all minor); there were no major complications. Readmission rate was 1.2 % (one patient). There was no surgical-related mortality. Followup to 90 days was 89 %, but steadily declined to 42 % at 6 years (72 months). The %EWL was 72 % at 72 months. Conclusion LMGB can be safely performed with good weight loss in patients C60 years old, despite numerous comorbidities and previous abdominal operations. & Cesare Peraglie [email protected] 1
Heart of Florida Regional Medical Center, 40124 Highway 27, Suite 203, Davenport, FL 33837, USA
Keywords Laparoscopic Bariatric surgery Minigastric bypass Medicare
Obesity is now a pandemic affecting people of all ages. While most of the focus has been on therapy for middle-age patients, since 1990 the prevalence of obesity has increased more than 50 % in the elderly [1]. As the population continues to age, the proportion of patients C60 years with obesity has reached *25 % [2]. In 2006, the Centers for Medicare and Medicaid Services established a National Coverage Determination, having found that bariatric surgery is safe and effective in the covered population but that data in the elderly population were lacking. Because of increased comorbidities with age, elderly patients pose a greater surgical risk of morbidity and mortality [3, 4], and there was a warning against bariatric surgery for patients [65 years of age [5]. Recently, however, numerous authors have published studies on the safety and efficacy of bariatric operations in this patient population [2, 6–10]. The laparoscopic mini-gastric bypass (LMGB), also known as the one-anastomosis or omega-loop gastric bypass, was devised 16 years ago by Dr. Robert Rutledge [11, 12] and has been adopted progressively by bariatric surgeons [13–22], as a safe, rapid and effective procedure. After performing various bariatric operations, the author was trained in the LMGBP by Dr. Rutledge and has been conferring with the other LMGBP surgeons worldwide, especially at the annual Paris LMGB Consensus Conferences. Papers have been published showing superiority of the LMGBP to the Roux-en-Y gastric bypass (RYGBP) and the sleeve gastrectomy (SG) [23–32]. We present a study of the LMGB in patients C60 years who have been evaluated with respect to outcomes from the perioperative period up to 6 years postoperatively.
123
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Materials and methods From 2007 to 2013, all patients who had LMGB were entered prospectively into a database that was then retrospectively reviewed to identify all patients age C60 years. Preoperatively, all patients were required to undergo a multi-step program that included extensive education on the procedure as well as potential risks and complications. Patients were also required to have medical and psychological clearance, laboratory evaluation including H. pylori testing, complete blood count (CBC), comprehensive metabolic panel (CMP) and vitamin D levels. In the event of H. pylori positivity or low vitamin D, treatment for eradication or vitamin D supplementation was given prior to surgery. All patients were seen one-on-one by the surgeon (CP), and all attended an extensive group clinic before surgery, where patients and family were exposed to another educational session and again encouraged to ask questions. The technique of LMGB (Fig. 1) has been previously well described [11, 12, 17, 19]. All patients had sequential compression devices and elastic stockings placed prior to induction of anesthesia, and no pharmacologic anticoagulation was utilized. Intravenous antibiotics were administered within 1 h before skin incision. All patients were placed in the supine position, with pillows and eggcrate foam to protect against compression injuries. Five trocars were used in most cases (two 12 mm, two 10 mm
and one 5 mm). Creation of the long pouch was begun by stapling at the area of the crow’s foot (just below the incisura) and continued parallel to the lesser curve with sequential firings to the angle of His (which was not dissected), alongside a 28F bougie. Staple-line reinforcement was not performed unless clinically indicated. The length of small bowel bypassed distal to Treitz’ ligament was selected according to the BMI and amount of excess weight [33]; most common length was 180 cm. The anastomosis was then performed side-to-side with an endo-GIA. It was closed with another firing of the stapler and oversewn with a circumferential running suture. Postoperatively, all patients were admitted to a standard postsurgical floor, and no urinary or nasogastric intubation was utilized. At time of discharge, patients were required to remain within 1 h of driving distance from the hospital for 1 week and to contact the surgeon daily. At 1 week, patients were seen in the office for the first postoperative checkup, and they were given an additional information session as well as forms for their primary care physician and for follow-up. Patients were followed up at 1 month and then every 3 months for the first 2 years. Follow-up is typically done in the office by the operating surgeon face-to-face. In the event that patients are unable to return to the office, they are required to maintain the same schedule with their primary care physician (PCP), but must also send us the follow-up forms (provided to them at the 1-week visit) as well as copies of the PCP notes. Laboratory testing was done every 6 months for the first 2 years and then yearly. These include CBC, CMP, water and fat-soluble vitamin levels, iron studies, parathyroid hormone (PTH) and HbA1c if diabetic, with supplements adjusted as necessary. Salicylates, smoking, alcohol and soda consumption were forbidden. Routine empiric endoscopy was not done as there is no indication for surveillance of B2 gastrojejunostomies that has been established in the surgical literature. Any patients who subsequently develop symptoms such as pain or bilious vomiting are first questioned regarding smoking and dietary choices. Patients are then managed for acid reflux and if no improvement then studied typically with upper endoscopy and on occasion upper contrast studies. If patients did not follow up, they were contacted by phone and e-mail. If they do not respond, we then send a letter by regular mail.
Results
Fig. 1 Laparoscopic mini-gastric bypass. A long mildly restricting but non-obstructing gastric conduit is anastomosed in easy view antecolic to the jejunal loop, providing malabsorption
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From 2007–2013, a total of 758 patients underwent LMGB. On review of the database, 88 (12 %) were age C60, with 62 % female and 38 % male. Average age at operation was 64 years (60–74), and average weight and BMI were 118 kg (78–171) and 43 kg/m2 (33–61), respectively. (The one patient with BMI \ 35 had had a previous
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abdominoplasty and had medically refractory diabetes. Postoperatively, she has done very well.) Patients had multiple comorbidities (Table 1), and more than one-third had had previous abdominal surgery (Table 2). All patients underwent the LMGB, and there were no conversions to open. Average operative time was 71 min (43–173). One patient suffered a capsular tear of the spleen, and another had bleeding from the splenic hilum; both were managed with packing and observation. No patient required transfusion, splenectomy or conversion to open laparotomy. Postoperatively, the patients were transferred to a standard postsurgical floor on telemetry. One patient, while in the recovery room, required temporary re-intubation and was observed overnight in the ICU and then transferred to the surgical floor the following morning. Average length of stay (LOS) was 1.2 days (1–3). Only one patient required readmission for 23-h observation due to a bleeding portsite while at home; this was managed by simple suture ligation of the wound at the bedside, and the patient was discharged the following morning. The overall complication rate was 4.5 % (4 patients), and these were all minor (Table 3). There were no cases of wound infection, anastomotic stricture requiring dilatation or internal hernia in
this cohort. There was no surgical mortality in the entire group. One patient was deceased 2 years postoperatively from an anaplastic carcinoma of the thyroid, and one patient was diagnosed with a breast carcinoma 3 years postoperatively. Both patients had maintained follow-up [1 year and were doing well prior to their cancer. After 1 year, resolution of diabetes occurred in 84 % of diabetics and hypertension resolved in 76 % of hypertensives. There has been no bile reflux or marginal ulcer occurrences noted to date. One patient from out of state, however, was lost to follow-up at 9 months. Apparently, this patient suffered a myocardial infarction at 18 months post-op, and according to a family member, he was converted to RYGB for unknown reason. The situation was very unclear, and we were unable to get any return calls from patient or his physicians. Follow-up at 90 days was 89 %. Patients have been followed and evaluated up to 72 months. Despite numerous attempts to contact patients, many had changed their e-mail address, telephone numbers and even city of residence. Table 4 shows the follow-up rates and %EWL for the corresponding time-periods.
Table 3 Complications Complication
Table 1 Patient comorbidities Comorbidity
Patients (%)
Hypertension
67 (76 %)
Diabetes type 2
40 (45 %)
Dyslipidemia
36 (41 %)
DM/HTN/lipida
20 (23 %)
CADb
10 (11 %)
Coronary stents
6 (7 %)
Plavix/Coumadin
6 (7 %)
a
DM/HTN/lipid = diabetes, hypertension, dyslipidemia in the same patient b
CAD coronary artery disease
Patients (%)
Bleeding port-site
2 (2)
Reintubation
1 (1)
Readmission Oral thrush
1 (1) 1 (1)
Mortality—in hospital
0
Mortality—30 days
0
Mortality—90 days
0
Leak
0
DVT/PE
0
Transfusion
0
Reoperation
0
Table 4 Follow-up and %EWL Table 2 Previous abdominal operations Previous surgery
Patients (%)
Total abdominal hysterectomy
14 (16 %)
Ventral hernia repair with mesh
13 (15 %)
Open cholecystectomy Laparoscopic cholecystectomy
13 (15 %) 7 (8 %)
Time period (months)
Follow-up (%)
%EWL (%)
1
95
18
6
80
52
12 24
77 66
67 70
36
59
68
Abdominal lipectomy
5 (6 %)
48
51
66
Exploratory laparotomy
2 (3 %)
60
45
67
Colon resection
1 (2 %)
72
42
72
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Discussion There was initial skepticism of the LMGB, because it was mistaken by many to be similar to the Mason horizontal loop gastric bypass [34] where bile reflux adjacent to the esophagus had the potential to be problematic. Furthermore, there was a lack of understanding of the development of neoplasia in studies of bile in the rodent stomach. Indeed, after the Billroth II operation used for peptic ulcer and cancer for the past 100 years, studies for the development of carcinoma found a decreased incidence [35–38], even though H. pylori was not known or treated then. Furthermore, with bile insertion studies in the rodent stomach, Frantz and others [39, 40] showed that hyperplasia and neoplasia occurred in the proximal two-thirds of the unique rat’s stomach (which is squamous cell) but not in the distal glandular third (which corresponds to the human stomach). Although after the other bariatric operations [41–44], 44 cases of cancer have been reported, no case of carcinoma in the gastric pouch or esophagus has been reported after the LMGB, which has a long lesser curvature gastric pouch. After the thousands of vagotomy and pyloroplasties of the 1960s and 1970s for peptic ulcer (with bile in the distal stomach), gastric cancer did not develop. Thus, fear of gastric cancer after the LMGB is not borne out. The author (CP) has performed more than 1200 LMGBs since 2004, with fortunately no operative mortality. However, the role of bariatric surgery in patients C60 years old is unclear regarding safety and efficacy [5–10] and was the purpose of our study. With the rising incidence of this agegroup combined with the epidemic of obesity, the rate of bariatric operations in patients C60 is increasing. Printen and Mason [45] in 1977 described an 8 % 30-day mortality after bariatric surgery for patients [50 years of age. This was represented in the NIH Consensus Statement
that regarded age [50 as a potential contraindication to bariatric surgery [45]. Flum et al. [3] reported higher complication rates in patients [65 years of age, citing a 4.8 % 30-day and a 6.9 % 90-day mortality, and an 11.1 % mortality at 1 year. Moreover, they noted that the odds of death within 90 days were fivefold higher for older Medicare beneficiaries. Subsequently, Livingston et al. [5] reported a mortality rate that was three times higher in patients[55 than in younger patients. Despite these findings, in February 2006, the Centers for Medicare and Medicaid Services issued a National Coverage Determination, and the Medicare Advisory Committee found bariatric surgery to be safe and effective in the covered population, but noted that data on the elderly were limited. Our study represents a cohort of patients who were age C60 years who presented with significant comorbidities as well as operative challenges due to previous abdominal procedures. In reviewing the data on outcomes, our results are in line with those of gastric bypass procedures in this patient population (Table 5). Our data, however, has limitations. Despite aggressive attempts to contact patients and preoperative instruction, decreasing follow-up to 6 years showed difficulty in maintaining complete follow-up. Many of our patients are from out of state, and we were unable with time to see some of these patients in actual face-to-face encounters. In many situations, we had to rely on forms that were faxed, e-mailed, telephoned or followed up correspondence from primary care physicians. This loss of patient follow-up is consistent with other studies that look at long-term outcome. Follow-up rates in these studies ranged from 24 to 48.9 % [46–49]. Despite this, we believe that our results with the LMGB are favorable and comparable to recent reported series with respect to patient demographics, complications, mortality
Table 5 Gastric bypass in patients 60 ? years old Peraglie (current study)
O’Keefe [6]
Willkomm [2]
Wittgrove [7]
Dunkle-Batter [8]
Nelson [9]
Quebbeman [10]
Number of patients (n)
88
157
100
120
61
25
13
Age mean (range)
64 (60–74)
67 (65–78)
68 (65–77)
63 (60–74)
62 (60–72)
68
68 (65–73)
BMI (kg/m2)
43 (33–61)
48 (35–73)
45 (33–61)
45 (34–70)
49 (38–78)
50
45.8 ± 8.6
Laparoscopic
100 %
97 %
100
100 %
34 %
32 %
LOS days (mean)
1.2
2 (0–18)
1.97
Not stated
2.9
7±3
1.9
Complication
4.5 % (all minor)
NA
19 %
7.7 %
0
NA
1.7 %
16.9 (major to 90 days) 3.3 %
20 %
Re-operation
7 % (major)/33 % (minor) 2.5 %
4%
0
Mortality-total
0
1.35 % (1 year)
0 (30 days)
0
1.64
4%
0
30 days re-admit
1.2 % (1)
Not stated
6%
Not stated
Not stated
0
0
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and weight loss (Table 5). Long-term studies have shown that the LMGB results in a very favorable reduction in type 2 diabetes, hypertension and other comorbidities, compared with other bariatric operations [24–26, 30, 31].
Conclusion LMGB is a technically simple and safe procedure that offers the advantage of being fully reversible and revisable in a laparoscopic fashion. Despite what has been considered a higher-risk population with multiple comorbidities, outcomes were favorable with a low complication rate, no mortalities and favorable weight loss. Although follow-up was short and attrition was noted, the results are promising. Further study in patients C60 years of age with longer follow-up and attempted more rigid follow-up is contemplated. Acknowledgments The author is grateful to Mervyn Deitel, MD, FASMBS, FACN, CRCSC for suggestions with the study and manuscript. Disclosures Cesare Peraglie has no conflicts of interest or financial ties to disclose.
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