Evaluation of the safety and effectiveness of easyEndo™ universal stapler compared with easyEndo™ E-lite in patients submitted to gastric surgery: a retrospective/prospective study including a large number of patients

Italo Braghetto; Gustavo Czwiklitzer; Owen Korn; Percy Brante; Macarena Salinas

doi:10.18203/2349-2902.isj20243765

Authors

Italo Braghetto Department of Surgery, Hospital “José J. Aguirre”, Faculty of Medicine, University of Chile, Santiago, Chile https://orcid.org/0000-0003-2024-3029
Gustavo Czwiklitzer Department of Surgery, Hospital “San Juan de Dios”, Faculty of Medicine, University of Chile, Santiago, Chile https://orcid.org/0009-0006-1477-4471
Owen Korn Department of Surgery, Hospital “José J. Aguirre”, Faculty of Medicine, University of Chile, Santiago, Chile https://orcid.org/0000-0001-7840-2534
Percy Brante Department of Surgery, Faculty of Medicine, University of Los Andes, Santiago, Chile https://orcid.org/0000-0002-3781-0686
Macarena Salinas Department of Surgery, Hospital “José J. Aguirre”, Faculty of Medicine, University of Chile, Santiago, Chile https://orcid.org/0009-0008-9683-3723

DOI:

https://doi.org/10.18203/2349-2902.isj20243765

Keywords:

Laparoscopy, Gastric surgery, Stapler, Complications, Safety, Efficacy

Abstract

Background: Staple line complications represent the most dangerous complication after gastric surgery. Better-formed staples could potentially reduce complications postoperatively. The newer motorized generation stapling system would lead to fewer intraoperative staple line complications compared to traditional stapling systems. Purpose was to evaluate the safety and efficacy of these two types of stapler models by determining its intraoperative performance and peri-operative complications.

Methods: It was an observational cohort study including a total of 3613 patients submitted to gastric surgery for benign or malignant disease. The study was conducted within two periods: stage A using easyEndo^TM universal (n=2359 patients, from January 2017 to December 2022) and stage B (n=1254 patients, from January 2023 to June 2024) using easyEndo^TM E-lite motorized stapler including obese patients (n=3239), benign diseases with indication of surgical treatment (n=268) and patients with gastric cancer (n=106).

Results: Although higher rate of leaks and postoperative complications were observed in patients submitted to sleeve gastrectomy or gastric bypass during stage A compared with stage B (p=0.0025), both type of staplers are safe and effective for performing gastric surgery. In patients submitted to gastric resections, no significates differences were demonstrated in terms of postoperative complications comparing the two groups (p=0.1).

Conclusions: Patients operated on using motorized stapler presented less suture line interventions but no differences regarding postoperative complication. The results confirmed data published in previous reports and meta-analysis, but now including a big number of patients and complex procedures.

Metrics

Metrics Loading ...

References

Okazaki O, Bernardo WM, Brunaldi VO, Junior CCC, Minata MK, de Moura DTH, et al. Efficacy and Safety of Stents in the Treatment of Fistula After Bariatric Surgery: a Systematic Review and Meta-analysis. Obes Surg. 2018;28:1788-96. DOI: https://doi.org/10.1007/s11695-018-3236-6

Acquafresca PA, Palermo M, Rogula T, Duza GE, Serra E. Early surgical complications after gastric by-pass: a literature review. Arq Bras Cir Dig. 2015;28:74-80. DOI: https://doi.org/10.1590/s0102-67202015000100019

Odovic M, Clerc D, Demartines N, Suter M. Early Bleeding After Laparoscopic Roux-en-Y Gastric Bypass: Incidence, Risk Factors, and Management - a 21-Year Experience. Obes Surg. 2022;32:3232-8. DOI: https://doi.org/10.1007/s11695-022-06173-y

Markus A, Henrik BJ, Benedikt R, Alexander H, Thomas B, Clemens S, et al. Endoscopic vacuum therapy in salvage and standalone treatment of gastric leaks after bariatric surgery. Langenbecks Arch Surg. 2022;407:1039-46. DOI: https://doi.org/10.1007/s00423-021-02365-9

Sahloul M, Kapoulas S, Giet L, Ludwig C, Mahawar K, Dennison AR, et al. Does powered stapler improve the mechanical integrity of gastrojejunal anastomosis compared to the current techniques? Experimental study in ex vivo porcine models. J Minim Access Surg. 2022;18:90-6. DOI: https://doi.org/10.4103/jmas.JMAS_222_20

Alverdy JC. Biologically inspired gastrointestinal stapler design: "Getting to Zero" complications. Am J Surg. 2023;226:48-52. DOI: https://doi.org/10.1016/j.amjsurg.2023.01.030

Hasegawa S, Nakayama S, Hida K, Kawada K, Sakai Y. Effect of Tri-Staple Technology and Slow Firing on Secure Stapling Using an Endoscopic Linear Stapler. Dig Surg. 2015;32:353-60. DOI: https://doi.org/10.1159/000437216

Wang H, Ge W, Liu C, Wang P, Song C. Design and performance evaluation of a powered stapler for gastrointestinal anastomosis. Minim Invasive Ther Allied Technol. 2022;31:595-602. DOI: https://doi.org/10.1080/13645706.2020.1867585

Roy S , Yoo A, Yadalam S , Fegelman EJ , Kalsekar I, Johnston SF. Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers. J Med Econ. 2017;204:423-33. DOI: https://doi.org/10.1080/13696998.2017.1296453

Braghetto I, Korn O, Valladares H, Gutiérrez L, Csendes A, Debandi A, et al. Laparoscopic sleeve gastrectomy: surgical technique, indications, and clinical results. Obes Surg. 2007;17:1442-50. DOI: https://doi.org/10.1007/s11695-008-9421-2

Braghetto I, Martinez G, Korn O, Zamorano M, Lanzarini E, Narbona E. Laparoscopic subtotal gastrectomy in morbid obese patients: a valid option to laparoscopic gastric bypass in particular circumstances [prospective study]. Surg Today. 2018;48(5):558-65. DOI: https://doi.org/10.1007/s00595-018-1625-z

Braghetto I, Korn O, Csendes A, Gutiérrez L, Valladares H, Chacon M. Laparoscopic treatment of obese patients with gastroesophageal reflux disease and Barrett's esophagus: a prospective study. Obes Surg. 2012;22:764-72. DOI: https://doi.org/10.1007/s11695-011-0531-x

Braghetto I, Csendes A. Failure after fundoplication: re-fundoplication? is there a room for gastrectomy? in which clinical stage? Arq Bras Cir Dig. 2019;32(2):e1440. DOI: https://doi.org/10.1590/0102-672020190001e1440

Braghetto I, Korn O, Figueroa-Giralt M, Valenzuela C, Burgos AM, Mandiola C, et al. Laparoscopic redo fundoplication alone, redo Nissen fundoplication, or Toupet fundoplication combined with Roux-en-Y distal gastrectomy for treatment of failed Nissen fundoplication. Arq Bras Cir Dig. 2022;35:e1678. DOI: https://doi.org/10.1590/0102-672020220002e1678

Braghetto I, Korn O, Burgos A, Figueroa M. When should be converted laparoscopic sleeve gastrectomy to laparoscopic Roux-en-Y gastric bypass due to gastroesophageal reflux? Arq Bras Cir Dig. 2021;33(4):e1553. DOI: https://doi.org/10.1590/0102-672020200004e1553

Braghetto I, Lanzarini E, Musleh M, Gutierrez L, Molina JC, Korn O, et al. Lessons learned analyzing complications after laparoscopic total gastrectomy for gastric cancer. Arq Bras Cir Dig. 2020;33(3):e1539. DOI: https://doi.org/10.1590/0102-672020200003e1539

Zia MK, Morris-Stiff G, Luhmann A, Jeffries R, Ehsan O, Hassn A. Safety and application of laparoscopic gastrectomy for benign gastric disease and gastric cancer. Ann R Coll Surg Engl. 2011;93:17-21. DOI: https://doi.org/10.1308/003588410X12771863936963

Matsuzawa F, Homma S, Yoshida T, Konishi Y, Shibasaki S, Ishikawa T, et al. Serosal Laceration During Firing of Powered Linear Stapler Is a Predictor of Staple Malformation. Surg Innov. 2017;24:590-7. DOI: https://doi.org/10.1177/1553350617733350

Braghetto I, Burgos A, Lasnibat JP. Comparison of the Intragastric Volume and Pressure required to Cause a Leak Along the Suture Line in a Resected Stomach Post Sleeve Gastrectomy. Indian J Surg. 2021;1:1-5. DOI: https://doi.org/10.1007/s12262-021-02897-w

Serhan D, Koray A, Seymen B. The Effect of the Cartridge Used in Laparoscopic Sleeve Gastrectomy on the Development of a Staple-Line Leak. Surgeon. 2018;84:1499-503. DOI: https://doi.org/10.1177/000313481808400958

Redmann JG, Lavin TE, French MS. Improving hemostasis in sleeve gastrectomy with alternative stapler. JSLS. 2020;24:e2020.00073. DOI: https://doi.org/10.4293/JSLS.2020.00073

Rawlins L, Johnson BH, Johnston SS, Elangovanraaj N, Bhandari M, Cohen RV, et al. Comparative Effectiveness Assessment of Two Powered Surgical Stapling Platforms in Laparoscopic Sleeve Gastrectomy: A Retrospective Matched Study. Med Devices. 2020;13:195-204. DOI: https://doi.org/10.2147/MDER.S256237

Fegelman E, Knippenberg S, Schwiers M, Stefanidis D, Gersin KS, Scott JD, et al. Evaluation of a Powered Stapler System with Gripping Surface Technology on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2017;27:489-94. DOI: https://doi.org/10.1089/lap.2016.0513

Landreneau JP, Strong AT, Frider JS, Brethauer S, Lo Menzo E, Szomstein S. Use of alternative, cost-effective laparoscopic stapler reloads cartridges in bariatric surgery: a prospective, two-center pilot. Poster presented at: SAGES. Houston, TX; 2017.

Roberts KE, Hilton RL, Friedman DT, Frieder JS, Zhang X, Duffy AJ. Safety and feasibility of a lower-cost stapler in bariatric surgery. Obes Surg. 2019;29:401-5. DOI: https://doi.org/10.1007/s11695-018-3580-6

Braghetto I, Czwiklitzer G, Korn O, Brante P, Burgos AM. Results of mechanic versus motorized stapler used in gastric surgery: prospective study. Arq Bras Cir Dig. 2024;37:1818. DOI: https://doi.org/10.1590/0102-6720202400025e1818

Zilberstein B, Santo MA, Carvalho MH. Critical analysis of surgical treatment techniques of morbid obesity. Arq Bras Cir Dig. 2019;32(3):e1450. DOI: https://doi.org/10.1590/0102-672020190001e1450

Norero E, Quezada JL, Cerda J, Ceroni M, Martinez C, Mejía R, et al. Risk factors for severe postoperative complications after gastrectomy for gastric and esophagogastric junction cancers. Arq Bras Cir Dig. 2019;32:e1473. DOI: https://doi.org/10.1590/0102-672020190001e1473

Kassab P, da Costa WL Jr, Jacob CE, Cordts RM, Castro OAP, Barchi LC, et al. Brazilian Gastric Cancer Association. Minimally invasive surgery for gastric cancer in Brazil: status and perspectives-a report from the Brazilian Laparoscopic Oncologic Gastrectomy Group (BLOGG). Transl Gastroenterol Hepatol. 2017;2:45. DOI: https://doi.org/10.21037/tgh.2017.03.17

Calderón-Canseco IJ, Domínguez-Fonseca CB, Cerrillo-Miranda M, Pérez-Turrent MA, Fernández-Ananín S, Targarona Soler EM, et al. Comparative Analysis of Laparoscopic Gastrectomy Versus Laparoscopic-Assisted Gastrectomy: Postoperative Complications. Cureus. 2023;15:e51186. DOI: https://doi.org/10.7759/cureus.51186

Shimada S, Sawada N, Oae S, Seki J, Takano Y, Ishiyama Y, et al. Safety and curability of laparoscopic gastrectomy in elderly patients with gastric cancer. Surg Endosc. 2018;32:4277-83. DOI: https://doi.org/10.1007/s00464-018-6177-1

Makki H, Mahdy T, Emile SH, Nofal H, Asaad Y, Abdulateef O, et al. Analysis of Emergency Department Visits and Unplanned Readmission After Bariatric Surgery: An Experience from a Tertiary Referral Center. Surg Laparosc Endosc Percutan Tech. 2021;32:107-13. DOI: https://doi.org/10.1097/SLE.0000000000001011

Liu F, Huang C, Xu Z, Su X, Zhao G, Ye J, et al. Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial. JAMA Oncol. 2020;6:1590-7. DOI: https://doi.org/10.1001/jamaoncol.2020.3152

Abdikarim I, Cao XY, Li SZ, Zhao YQ, Taupyk Y, Wang Q. Enhanced recovery after surgery with laparoscopic radical gastrectomy for stomach carcinomas. World J Gastroenterol. 2015;21:13339-44. DOI: https://doi.org/10.3748/wjg.v21.i47.13339

Kang SH, Lee Y, Min SH, Park YS, Ahn SH, Park DJ, et al. Multimodal Enhanced Recovery After Surgery ERAS Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial. Ann Surg Oncol. 2018;25:3231-8. DOI: https://doi.org/10.1245/s10434-018-6625-0

Tanimura S, Higashino M, Fukunaga Y. Laparoscopic distal gastrectomy with regional lymph node dissection for gastric cancer. Surg Endosc. 2002;19:1177-81. DOI: https://doi.org/10.1007/s00464-004-8936-4

Olmi S, Giorgi R, Cioffi SPB, Uccelli M, Villa R, Ciccarese F, et al. Total and Subtotal Laparoscopic Gastrectomy for the Treatment of Advanced Gastric Cancer: Morbidity and Oncological Outcomes. .Laparoendosc Adv Surg Tech A. 2018;28:278-85. DOI: https://doi.org/10.1089/lap.2017.0372

Dias AR, Jacob CE, Ramos MFKP, Pereira MA, Szor DJ, Yagi OK, et al. Laparoscopic D2 Gastrectomy for Gastric Cancer: Mid-Term Results and Current Evidence. J Laparoendosc Adv Surg Tech A. 2019;9:495-502. DOI: https://doi.org/10.1089/lap.2018.0474

Li YJ, Huo TT, Xing J, An JZ, Han ZY, Liu XN, et al. Meta-analysis of efficacy and safety of fast-track surgery in gastrectomy for gastric cancer. World J Surg. 2014;38:3142-51. DOI: https://doi.org/10.1007/s00268-014-2690-0

Li Z, Wang Q, Li B, Bai B, Zhao Q. Influence of enhanced recovery after surgery programs on laparoscopy-assisted gastrectomy for gastric cancer: a systematic review and meta-analysis of randomized control trials. World J Surg Oncol. 2017;15:207. DOI: https://doi.org/10.1186/s12957-017-1271-8