The treatment of the metabolic syndrome with stapleless one-anastomotic gastric bypass: a randomized clinical trial compared to stapler method

BACKGROUND: The authors have developed an original method of laparoscopic gastric bypass significantly reducing financial costs when conducting this surgical treatment of obesity. In the presented article for the first time describes the evaluation of the effectiveness of the proposed to introduce a new type of staplerless gastric bypass compared to the standard stapler method.

AIMS: to evaluate the effectiveness of the author’s method of laparoscopic gastric bypass for the treatment of metabolic syndrome with obesity.

MATERIALS AND METHODS: This prospective, randomized controlled trial presents the results of surgical treatment of 80 patients with metabolic syndrome. Patients were randomized into two groups of 40 people. In the first group, the author’s method of laparoscopic mini-gastric bypass with a band-separated pouch was implemented, and in the second group, the standard laparoscopic mini-gastric bypass with a standard (stapler-separated) gastric pouch was used. Procedures were performed in the period from 2015 to 2016 with an average follow up period of 3 years. The postoperative change of weight loss and the changes of the main manifestations of the metabolic syndrome, as well as the change in the cardiovascular risk index in the comparison groups were assessed.

RESULTS: In both groups there were no significant differences by sex and age. In the first group there were 39 women and 1 man, and in the second group 36 women and 4 men aged 36.75±8.6 years and 40.47±11.0 years, respectively (p=0.097). Three years after surgery, all 80 patients were examined using analysis of variance. At the same time, it was revealed that the change in body mass index after operations, which was 14.02±5.05 kg/m² in the first group, and 12.38±5.7 kg/m² (p=0.170) in the second group, was found equally good bariatric effect of two compared methods of gastric bypass.

The main indicators of blood pressure, as well as laboratory data reflecting the state of carbohydrate and fat metabolism, statistically significantly decreased in both groups to normal values, which suggests a pronounced metabolic effect of both gastric bypass methods. It was established that cardiovascular risk in the first group decreased from 5.4±0.9 to 2.9±0.4 (p<0.001), and in the second group from 5.1±1.1 to 3.1±0.32 (p<0.001).

CONCLUSIONS: The results of the use of various types of laparoscopic gastric bypass in the surgical treatment of metabolic syndrome after three years indicate a significant reduction in body weight, normalization of carbohydrate and fat metabolism.

In a comparative aspect, the author’s and standard gastric bypass techniques equally positively affect the elimination of the main manifestations of the metabolic syndrome, but the proposed author’s method has insignificant advantages in terms of weight loss.

obesity, metabolic syndrome, bariatric surgery, laparoscopic gastric bypass, stapleless gastric bypass

1. Плохая А.А. Современные аспекты лечения метаболического синдрома. // Ожирение и метаболизм. — 2011. — Т. 8. — №3. — С. 31-37. [Plokhaya AA. Sovremennye aspekty lecheniya metabolicheskogo sindroma. Obesity and metabolism. 2011;8(3):31-37. (In Russ).] DOI:https://doi.org/10.14341/2071-8713-4834

2. Committee ACI. Bariatric surgery in class I obesity (body mass index 30-35 kg/m(2)). Surg Obes Relat Dis. 2013;9(1): e1-10. DOI:10.1016/j.soard.2012.09.002

3. Дедов И.И., Мельниченко Г.А., Шестакова М.В., и др. Национальные клинические рекомендации по лечению морбидного ожирения у взрослых. 3-ий пересмотр (лечение морбидного ожирения у взрослых). // Ожирение и метаболизм. — 2018. — Т. 15. — №1. — С. 53-70. [Dedov II, Mel’nichenko GA, Shestakova MV, et al. Russian national clinical recommendations for morbid obesity treatment in adults. 3rd revision (Morbid obesity treatment in adults). Obesity and metabolism. 2018;15(1):53-70. (In Russ).] DOI:10.14341/OMET2018153-70

4. Rubino F, Nathan DM, Eckel RH, et al. Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations. Diabetes Care. 2016;39(6):861-877. DOI:10.2337/dc16-0236

5. Benraouane F, Litwin SE. Reductions in cardiovascular risk after bariatric surgery. Curr Opin Cardiol. 2011;26(6):555-561. DOI:10.1097/HCO.0b013e32834b7fc4

6. Sjostrom L, Narbro K, Sjostrom CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007;357(8):741-752. DOI:10.1056/NEJMoa066254

7. Sundbom M. Laparoscopic revolution in bariatric surgery. World J Gastroenterol. 2014;20(41):15135-15143. DOI:10.3748/wjg.v20.i41.15135

8. Ospanov, O., Buchwald, J.N., Yeleuov, G. et al. OBES SURG (2019) 29: 4131. https://doi.org/10.1007/s11695-019-04236-1

9. Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006;23(5):469-480. DOI:10.1111/j.1464-5491.2006.01858.x

10. Carbajo M, Garcia-Caballero M, Toledano M, et al. One-anastomosis gastric bypass by laparoscopy: results of the first 209 patients. Obes Surg. 2005;15(3):398-404. DOI:10.1381/0960892053576677

11. Brethauer SA, Kim J, el Chaar M, et al. Standardized outcomes reporting in metabolic and bariatric surgery. Surg Obes Relat Dis. 2015;11(3):489-506. DOI:10.1016/j.soard.2015.02.003

12. Barzin M, Khalaj A, Motamedi MA, et al. Safety and effectiveness of sleeve gastrectomy versus gastric bypass: one-year results of Tehran Obesity Treatment Study (TOTS). Gastroenterol Hepatol Bed Bench. 2016;9(Suppl1):S62-S69.

13. Kraljevic M, Delko T, Kostler T, et al. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial. Trials. 2017;18(1):226. DOI:10.1186/s13063-017-1957-9

14. Rubino F, Schauer PR, Kaplan LM, Cummings DE. Metabolic surgery to treat type 2 diabetes: clinical outcomes and mechanisms of action. Annu Rev Med. 2010;61:393-411. DOI:10.1146/annurev.med.051308.105148

15. Adam S, Liu Y, Siahmansur T, et al. Bariatric surgery as a model to explore the basis and consequences of the Reaven hypothesis: Small, dense low-density lipoprotein and interleukin-6. Diab Vasc Dis Res. 2019;16(2):144-152. DOI:10.1177/1479164119826479

16. Schiavon CA, Bersch-Ferreira AC, Santucci EV, et al. Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension). Circulation. 2018;137(11):1132-1142. DOI:10.1161/CIRCULATIONAHA.117.032130

17. Harchaoui KE, Visser ME, Kastelein JJ, et al. Triglycerides and cardiovascular risk. Curr Cardiol Rev. 2009;5(3):216-222. DOI:10.2174/157340309788970315

18. Hokanson JE, Austin MA. Plasma Triglyceride Level is a Risk Factor for Cardiovascular Disease Independent of High-Density Lipoprotein Cholesterol Level: A Metaanalysis of Population-Based Prospective Studies. Eur J Cardiovasc Prev Rehabil. 1996;3(2):213-219. DOI:10.1177/174182679600300214

19. Metabolic mediators of the effects of body-mass index, overweight, and obesity on coronary heart disease and stroke: a pooled analysis of 97 prospective cohorts with 1·8 million participants. Lancet. 2014;383(9921):970-983. DOI:10.1016/s0140-6736(13)61836-x