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Open Access 01-05-2016

Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler

Authors: Andreas Kuthe, Alexander Haemmerle, Kaja Ludwig, Stephan Falck, Wolfgang Hiller, Frederick Mainik, Stephan Freys, Lev Dubovoy, Joachim Jaehne, Karl Oldhafer

Published in: Surgical Endoscopy | Issue 5/2016

Abstract

Background

The objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications.

Methods

A prospective, single-arm study with an open enrollment of subjects requiring stapling of the gastrointestinal (GI) tract was performed. The study endpoints were the number of complications and technical failures associated with the use of a novel stapler when compared to similar events with conventional staplers as described in the medical literature.

Results

Seven centers enrolled 160 subjects, 150 of which were followed up to at least 30 days postoperatively. Intraoperative success: In 423 deployments, there were two staple line leaks and five staple line bleeds, all of which were intraoperatively resolved. In addition, incomplete staple lines were noted as a result of user error (n = 15) or device-related issues (n = 22), all of which were immediately resolved and none of which resulted in a complication or a change of the surgical procedure. Late outcomes: A total of 13 surgical complications in 160 patients were related to a GI transection or anastomosis, 12 of which related to a hand-sewn anastomosis or use of other commercially available staplers. One event (1/153, 0.065 %) on POD 1, involving bleeding of the staple line, was felt to be related to the use of the new stapler.

Conclusion

The study confirmed that the new device was user-friendly (9 % incidence of problems firing the device), reliable (3 % device failures) and safe (<1 % complication rate related to the stapler). Based on these results, it would seem that this new 5-mm stapler is a safe and effective alternative to standard 12-mm staplers.

Excluding subjects without severe adverse events that did not complete 30-day follow-up (n = 7).

Karthik S, Augustine AJ, Shibumon MM, Pai MV (2013) Analysis of laparoscopic port site complications: a descriptive study. J Minim Access Surg 9:59–64CrossRefPubMedPubMedCentral

David G, Boni L, Rausei S, Cassinotti E, Dionigi G, Rovera F, Spampatti S, Colombo EM, Dionigi R (2013) Use of 3 mm percutaneous instruments with 5 mm end effectors during different laparoscopic procedures. Int J Surg 11(Suppl 1):S61–S63CrossRefPubMed

Lee SW, Milsom JW, Nash GM (2011) Single-incision versus multiport laparoscopic right and hand-assisted left colectomy: a case-matched comparison. Dis Colon Rectum 54:1355–1361CrossRefPubMed

Comajuncosas J, Hermoso J, Gris P, Jimeno J, Orbeal R, Vallverdu H, Lopez Negre JL, Urgelles J, Estalella L, Pares D (2014) Risk factors for umbilical trocar site incisional hernia in laparoscopic cholecystectomy: a prospective 3-year follow-up study. Am J Surg 207:1–6CrossRefPubMed

Tonouchi H, Ohmori Y, Kobayashi M, Kusunoki M (2004) Trocar site hernia. Arch Surg 139:1248–1256CrossRefPubMed

Kouba EJ, Hubbard JS, Wallen E, Pruthi RS (2007) Incisional hernia in a 12-mm non-bladed trocar site following laparoscopic nephrectomy. Urol Int 79:276–279CrossRefPubMed

The Helsinki Declaration of the World Medical Association (WMA) (2014) Ethical principles of medical research involving human subjects. Pol Merkur Lekarski 36:298–301

Daabiss M (2011) American Society of Anaesthesiologists physical status classification. Indian J Anaesth 55:111–115CrossRefPubMedPubMedCentral

Demertzis S, Beslac O, Mettler D, Zalokar D, Spangler T, Hausen B, Swanstrom L (2015) Beyond the “B”: a new concept of the surgical staple enabling miniature staplers. Surg Endosc. doi:10.1007/s00464-015-4125-x

10.

Abdel-Galil E, Sabry AA (2002) Laparoscopic Roux-en-Y gastric bypass—evaluation of three different techniques. Obes Surg 12:639–642CrossRefPubMed

11.

Albanopoulos K, Alevizos L, Flessas J, Menenakos E, Stamou KM, Papailiou J, Natoudi M, Zografos G, Leandros E (2012) Reinforcing the staple line during laparoscopic sleeve gastrectomy: prospective randomized clinical study comparing two different techniques. Preliminary results. Obes Surg 22:42–46CrossRefPubMed

12.

Albanopoulos K, Alevizos L, Linardoutsos D, Menenakos E, Stamou K, Vlachos K, Zografos G, Leandros E (2011) Routine abdominal drains after laparoscopic sleeve gastrectomy: a retrospective review of 353 patients. Obes Surg 21:687–691CrossRefPubMed

13.

Armstrong J, O’Malley SP (2010) Outcomes of sleeve gastrectomy for morbid obesity: a safe and effective procedure? Int J Surg 8:69–71CrossRefPubMed

14.

Balsiger BM, Kennedy FP, Abu-Lebdeh HS, Collazo-Clavell M, Jensen MD, O’Brien T, Hensrud DD, Dinneen SF, Thompson GB, Que FG, Williams DE, Clark MM, Grant JE, Frick MS, Mueller RA, Mai JL, Sarr MG (2000) Prospective evaluation of Roux-en-Y gastric bypass as primary operation for medically complicated obesity. Mayo Clin Proc 75:673–680CrossRefPubMed

15.

Beldi G, Vorburger SA, Bruegger LE, Kocher T, Inderbitzin D, Candinas D (2006) Analysis of stapling versus endoloops in appendiceal stump closure. Br J Surg 93:1390–1393CrossRefPubMed

16.

Blachar A, Federle MP, Pealer KM, Ikramuddin S, Schauer PR (2002) Gastrointestinal complications of laparoscopic Roux-en-Y gastric bypass surgery: clinical and imaging findings. Radiology 223:625–632CrossRefPubMed

17.

Blumetti J, Luu M, Sarosi G, Hartless K, McFarlin J, Parker B, Dineen S, Huerta S, Asolati M, Varela E, Anthony T (2007) Surgical site infections after colorectal surgery: do risk factors vary depending on the type of infection considered? Surgery 142:704–711CrossRefPubMed

18.

Brundage SI, Jurkovich GJ, Hoyt DB, Patel NY, Ross SE, Marburger R, Stoner M, Ivatury RR, Ku J, Rutherford EJ, Maier RV, WTAM-iSGWT Association (2001) Stapled versus sutured gastrointestinal anastomoses in the trauma patient: a multicenter trial. J Trauma 51:1054–1061CrossRefPubMed

19.

Choi HK, Law WL, Ho JW (2006) Leakage after resection and intraperitoneal anastomosis for colorectal malignancy: analysis of risk factors. Dis Colon Rectum 49:1719–1725CrossRefPubMed

20.

Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie AE (2007) Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev 18(3):CD004320

21.

Daskalakis M, Berdan Y, Theodoridou S, Weigand G, Weiner RA (2011) Impact of surgeon experience and buttress material on postoperative complications after laparoscopic sleeve gastrectomy. Surg Endosc 25:88–97CrossRefPubMed

22.

DeMaria EJ, Sugerman HJ, Kellum JM, Meador JG, Wolfe LG (2002) Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg 235:640–645 (discussion 645–647) CrossRefPubMedPubMedCentral

23.

Didolkar MS, Reed WP, Elias EG, Schnaper LA, Brown SD, Chaudhary SM (1986) A prospective randomized study of sutured versus stapled bowel anastomoses in patients with cancer. Cancer 57:456–460CrossRefPubMed

24.

Docherty JG, McGregor JR, Akyol AM, Murray GD, Galloway DJ (1995) Comparison of manually constructed and stapled anastomoses in colorectal surgery. West of Scotland and Highland Anastomosis Study Group. Ann Surg 221:176–184CrossRefPubMedPubMedCentral

25.

Dresel A, Kuhn JA, Westmoreland MV, Talaasen LJ, McCarty TM (2002) Establishing a laparoscopic gastric bypass program. Am J Surg 184:617–620 (discussion 620) CrossRefPubMed

26.

Finks JF, Carlin A, Share D, O’Reilly A, Fan Z, Birkmeyer J, Birkmeyer N, Michigan Bariatric Surgery Collaborative from the Michigan Surgical Collaborative for Outcomes Research Evaluation (2011) Effect of surgical techniques on clinical outcomes after laparoscopic gastric bypass—results from the Michigan Bariatric Surgery Collaborative. Surg Obes Relat Dis 7:284–289CrossRefPubMed

27.

Giordano S, Tolonen P, Victorzon M (2010) Comparison of linear versus circular stapling techniques in laparoscopic gastric bypass surgery—a pilot study. Scand J Surg 99:127–131PubMed

28.

Gould JC, Needleman BJ, Ellison EC, Muscarella P, Schneider C, Melvin WS (2002) Evolution of minimally invasive bariatric surgery. Surgery 132:565–571 (discussion 571–562) CrossRefPubMed

29.

Higa KD, Boone KB, Ho T (2000) Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients—what have we learned? Obes Surg 10:509–513CrossRefPubMed

30.

Hyman N, Manchester TL, Osler T, Burns B, Cataldo PA (2007) Anastomotic leaks after intestinal anastomosis: it’s later than you think. Ann Surg 245:254–258CrossRefPubMedPubMedCentral

31.

Kirkpatrick JR, Zapas JL (1998) Divided gastric bypass: a fifteen-year experience. Am Surg 64:62–65 (discussion 65–66) PubMed

32.

Kligman MD, Thomas C, Saxe J (2003) Effect of the learning curve on the early outcomes of laparoscopic Roux-en-Y gastric bypass. Am Surg 69:304–309 (discussion 309–310) PubMed

33.

Kockerling F, Rose J, Schneider C, Scheidbach H, Scheuerlein H, Reymond MA, Reck T, Konradt J, Bruch HP, Zornig C, Barlehner E, Kuthe A, Szinicz G, Richter HA, Hohenberger W (1999) Laparoscopic colorectal anastomosis: risk of postoperative leakage. Results of a multicenter study. Laparoscopic Colorectal Surgery Study Group (LCSSG). Surg Endosc 13:639–644CrossRefPubMed

34.

Kracht M, Hay JM, Fagniez PL, Fingerhut A (1993) Ileocolonic anastomosis after right hemicolectomy for carcinoma: stapled or hand-sewn? A prospective, multicenter, randomized trial. Int J Colorectal Dis 8:29–33CrossRefPubMed

35.

Lacy A, Ibarzabal A, Pando E, Adelsdorfer C, Delitala A, Corcelles R, Delgado S, Vidal J (2010) Revisional surgery after sleeve gastrectomy. Surg Laparosc Endosc Percutan Tech 20:351–356CrossRefPubMed

36.

Law WL, Choi HK, Lee YM, Ho JW, Seto CL (2007) Anastomotic leakage is associated with poor long-term outcome in patients after curative colorectal resection for malignancy. J Gastrointest Surg 11:8–15CrossRefPubMed

37.

Li VK, Wexner SD, Pulido N, Wang H, Jin HY, Weiss EG, Nogeuras JJ, Sands DR (2009) Use of routine intraoperative endoscopy in elective laparoscopic colorectal surgery: can it further avoid anastomotic failure? Surg Endosc 23:2459–2465CrossRefPubMed

38.

Linn TY, Moran BJ, Cecil TD (2008) Staple line haemorrhage following laparoscopic left-sided colorectal resections may be more common when the inferior mesenteric artery is preserved. Tech Coloproctol 12:289–293CrossRefPubMed

39.

Lipska MA, Bissett IP, Parry BR, Merrie AE (2006) Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg 76:579–585CrossRefPubMed

40.

Liu CD, Glantz GJ, Livingston EH (2003) Fibrin glue as a sealant for high-risk anastomosis in surgery for morbid obesity. Obes Surg 13:45–48CrossRefPubMed

41.

Livingston EH, Huerta S, Arthur D, Lee S, De Shields S, Heber D (2002) Male gender is a predictor of morbidity and age a predictor of mortality for patients undergoing gastric bypass surgery. Ann Surg 236:576–582CrossRefPubMedPubMedCentral

42.

Lujan JA, Frutos MD, Hernandez Q, Liron R, Cuenca JR, Valero G, Parrilla P (2004) Laparoscopic versus open gastric bypass in the treatment of morbid obesity: a randomized prospective study. Ann Surg 239:433–437CrossRefPubMedPubMedCentral

43.

MacLean LD, Rhode BM, Sampalis J, Forse RA (1993) Results of the surgical treatment of obesity. Am J Surg 165:155–160 (discussion 160–152) CrossRefPubMed

44.

Matthews BD, Sing RF, DeLegge MH, Ponsky JL, Heniford BT (2000) Initial results with a stapled gastrojejunostomy for the laparoscopic isolated roux-en-Y gastric bypass. Am J Surg 179:476–481CrossRefPubMed

45.

Mazeh H, Greenstein AJ, Swedish K, Nguyen SQ, Lipskar A, Weber KJ, Chin EH, Divino CM (2009) Laparoscopic and open reversal of Hartmann’s procedure—a comparative retrospective analysis. Surg Endosc 23:496–502CrossRefPubMed

46.

McKinlay R, Neeleman S, Klein R, Stevens K, Greenfeld J, Ghory M, Cosentino C (2003) Intraabdominal abscess following open and laparoscopic appendectomy in the pediatric population. Surg Endosc 17:730–733CrossRefPubMed

47.

McManus KG, Ritchie AJ, McGuigan J, Stevenson HM, Gibbons JR (1990) Sutures, staplers, leaks and strictures. A review of anastomoses in oesophageal resection at Royal Victoria Hospital, Belfast 1977–1986. Eur J Cardiothorac Surg 4:97–100CrossRefPubMed

48.

Nguyen NT, Ho HS, Palmer LS, Wolfe BM (2000) A comparison study of laparoscopic versus open gastric bypass for morbid obesity. J Am Coll Surg 191:149–155 (discussion 155–147) CrossRefPubMed

49.

Nguyen NT, Neuhaus AM, Ho HS, Palmer LS, Furdui GG, Wolfe BM (2001) A prospective evaluation of intracorporeal laparoscopic small bowel anastomosis during gastric bypass. Obes Surg 11:196–199CrossRefPubMed

50.

Oliak D, Ballantyne GH, Davies RJ, Wasielewski A, Schmidt HJ (2002) Short-term results of laparoscopic gastric bypass in patients with BMI ≥60. Obes Surg 12:643–647CrossRefPubMed

51.

Platell C, Barwood N, Dorfmann G, Makin G (2007) The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis 9:71–79CrossRefPubMed

52.

Ramirez MC, Rodriguez J, Varghese F, Atkinson WH, Rhodes D, Rajab MH, Symmonds R (2010) Reinforced circular stapler in bariatric surgery. JSLS 14:358–363CrossRefPubMedPubMedCentral

53.

Rutledge R (2001) The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg 11:276–280CrossRefPubMed

54.

Sajid MS, Khatri K, Singh K, Sayegh M (2011) Use of staple-line reinforcement in laparoscopic gastric bypass surgery: a meta-analysis. Surg Endosc 25:2884–2891CrossRefPubMed

55.

Sakran N, Assalia A, Sternberg A, Kluger Y, Troitsa A, Brauner E, Van Cauwenberge S, De Visschere M, Dillemans B (2011) Smaller staple height for circular stapled gastrojejunostomy in laparoscopic gastric bypass: early results in 1,074 morbidly obese patients. Obes Surg 21:238–243CrossRefPubMed

56.

Santos RS, Raftopoulos Y, Singh D, DeHoyos A, Fernando HC, Keenan RJ, Luketich JD, Landreneau RJ (2004) Utility of total mechanical stapled cervical esophagogastric anastomosis after esophagectomy: a comparison to conventional anastomotic techniques. Surgery 136:917–925CrossRefPubMed

57.

Schwartz ML, Drew RL, Chazin-Caldie M (2003) Laparoscopic Roux-en-Y gastric bypass: preoperative determinants of prolonged operative times, conversion to open gastric bypasses, and postoperative complications. Obes Surg 13:734–738CrossRefPubMed

58.

Shelygin YA, Chernyshov SV, Rybakov EG (2010) Stapled ileostomy closure results in reduction of postoperative morbidity. Tech Coloproctol 14:19–23CrossRefPubMed

59.

Shope TR, Cooney RN, McLeod J, Miller CA, Haluck RS (2003) Early results after laparoscopic gastric bypass: EEA vs GIA stapled gastrojejunal anastomosis. Obes Surg 13:355–359CrossRefPubMed

60.

Sims TL, Mullican MA, Hamilton EC, Provost DA, Jones DB (2003) Routine upper gastrointestinal Gastrografin swallow after laparoscopic Roux-en-Y gastric bypass. Obes Surg 13:66–72CrossRefPubMed

61.

Suter M, Giusti V, Heraief E, Zysset F, Calmes JM (2003) Laparoscopic Roux-en-Y gastric bypass: initial 2-year experience. Surg Endosc 17:603–609CrossRefPubMed

62.

Szomstein S, Whipple OC, Zundel N, Cal P, Rosenthal R (2006) Laparoscopic Roux-en-Y gastric bypass with linear cutter technique: comparison of four-row versus six-row cartridge in creation of anastomosis. Surg Obes Relat Dis 2:431–434CrossRefPubMed

63.

Tang R, Chen HH, Wang YL, Changchien CR, Chen JS, Hsu KC, Chiang JM, Wang JY (2001) Risk factors for surgical site infection after elective resection of the colon and rectum: a single-center prospective study of 2,809 consecutive patients. Ann Surg 234:181–189CrossRefPubMedPubMedCentral

64.

Toppino M, Cesarani F, Comba A, Denegri F, Mistrangelo M, Gandini G, Morino F (2001) The role of early radiological studies after gastric bariatric surgery. Obes Surg 11:447–454CrossRefPubMed

65.

Wittgrove AC, Clark GW (2000) Laparoscopic gastric bypass, Roux-en-Y- 500 patients: technique and results, with 3–60 month follow-up. Obes Surg 10:233–239CrossRefPubMed

66.

Xu QR, Wang KN, Wang WP, Zhang K, Chen LQ (2011) Linear stapled esophagogastrostomy is more effective than hand-sewn or circular stapler in prevention of anastomotic stricture: a comparative clinical study. J Gastrointest Surg 15:915–921CrossRefPubMed

67.

Yendamuri S, Gutierrez L, Oni A, Mashtare T, Khushalani N, Yang G, Nava H, Demmy T, Nwogu C (2011) Does circular stapled esophagogastric anastomotic size affect the incidence of postoperative strictures? J Surg Res 165:1–4CrossRefPubMed

68.

Geis WP, Kim HC (1994) Preceptors, complexity scales, and local factors in influencing success in laparoscopic colectomy procedures. Int Surg 79:230–232 PubMed

69.

Geis WP, Coletta AV, Jacobs M, Placensia G, Kim HC (1994) Benefits of complexity scales in laparoscopic colectomy. Int Surg 79:230–232PubMed

70.

Hardin DM Jr (1999) Acute appendicitis: review and update. Am Fam Physician 60:2027–2034PubMed

71.

Schauer PR, Ikramuddin S, Hamad G, Eid GM, Mattar S, Cottam D, Ramanathan R, Gourash W (2003) Laparoscopic gastric bypass surgery: current technique. J Laparoendosc Adv Surg Tech A 13:229–239CrossRefPubMed

72.

Sonoda T, Verdeja JC, Rivadeneira DE (2011) Stapler access and visibility in the deep pelvis: a comparative human cadaver study between a computerized right angle linear cutter versus a curved cutting stapler. Ann Surg Innov Res 5:7CrossRefPubMedPubMedCentral

Title: Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler
Authors: Andreas Kuthe
Alexander Haemmerle
Kaja Ludwig
Stephan Falck
Wolfgang Hiller
Frederick Mainik
Stephan Freys
Lev Dubovoy
Joachim Jaehne
Karl Oldhafer
Publication date: 01-05-2016
Publisher: Springer US
Published in: Surgical Endoscopy / Issue 5/2016
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-015-4406-4

At a glance: The STEP trials

Springer Medicine

Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler

Abstract

Background

Methods

Results

Conclusion

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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