International Journal of Colorectal Disease

, Volume 33, Issue 11, pp 1635–1641 | Cite as

Intracorporeal versus extracorporeal anastomosis in right hemicolectomy assisted by laparoscopy: study protocol for a randomized controlled trial

  • J. BolloEmail author
  • P. Salas
  • M. C. Martinez
  • P. Hernandez
  • A. Rabal
  • E. Carrillo
  • E. Targarona
Clinical Study Protocol



Colorectal cancer (CRC) is the third most frequent cancer diagnosed in men and the second in women. Laparoscopic surgery has been a technical revolution in colorectal surgery, facilitating a better recovery of patients with lower morbidity and better esthetic results, compared to traditional surgery via laparotomy, without compromising safety and long-term oncological results.


The trial is a randomized controlled trial indented to evaluate the two interventions with thorough measurements of the postoperative variables and complications to improve the evaluation of the surgical technique. The primary endpoint is to compare the hospital stay, which will be measured in days between both groups. The purpose of the study at secondary endpoints is to compare intraoperative and postoperative events between both groups in terms of operating time, anastomotic performance time, intraoperative complications, number of harvested lymph nodes, need for blood transfusion, length of the surgical wound, start and tolerance of oral intake, beginning of digestive functionality, postoperative pain, need for analgesic administration, surgical wound infection, paralytic ileus, anastomosis leakage or dehiscence, need for surgical reintervention, and hospital readmission within the first 30 days after surgery.


This trial is a prospective, randomized, single-blind, and single-center clinical trial comparing intracorporeal anastomosis versus extracorporeal anastomosis for right laparoscopic hemicolectomy.


Nowadays, there are several retrospective trials comparing the benefits for extracorporeal anastomosis versus intracorporeal anastomosis in right colon cancer patients. Considering the impact for laparoscopic surgery, we think it is necessary to do a randomized trial comparing extracorporeal versus intracorporeal anastomosis modalities.

Trial registration No. NCT02667860 and Hospital de la Santa Creu i Sant Pau Research Institute No. IIBSP-AIE-2015-01


Intracorporeal Anastomosis Right hemicolectomy Laparoscopy 


Compliance with ethical standards

The study will rigorously follow the international ethical recommendations for research and clinical trials in humans. Likewise, the standards contained in the Declaration of Helsinki will be guaranteed and will be developed in accordance with the protocol and standardized work procedures.

The ethical approval of this study has been obtained from the ethics committee at Hospital de la Santa Creu i Sant Pau and the research institute.


  1. 1.
    Torre L, Bray F, Siegel R, Ferlay J, Lortet-Tieulent J, Jemal A (2015) Global Cancer Statistics, 2012. CA Cancer J Clin 65:87–108CrossRefGoogle Scholar
  2. 2.
    El-Shami K, Oeffinger K, Erb N, Willis A, Bretsch J, Pratt-Chapman M, Cannady R, Wong S, Rose J, Barbour A, Stein K, Sharpe K, Brooks D, Cowens-Alvarado R (2015) American Cancer Society colorectal cancer survivorship care guidelines. CA Cancer J Clin 65:428–455CrossRefGoogle Scholar
  3. 3.
    Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pâlman L, Cuesta MA, Msika S, Morino M, Lacy AM, COLOR study group (2005) Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 6:477–484CrossRefGoogle Scholar
  4. 4.
    Clinical Outcomes of Surgical Therapy Study Group (2004) A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350:2050–2059CrossRefGoogle Scholar
  5. 5.
    Guillou P, Quirke P, Thorpe H, Walker J, Jayne D, Smith A, Heath R, Brown J (2005) Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASSICC trial): multicenter, randomized controlled trial. Lancet 365:1718–1726CrossRefGoogle Scholar
  6. 6.
    Simillis C, Purkayastha S, Yamamoto T, Strong SA, Darzi AW, Tekkis PP (2007) A meta-analysis comparing conventional end-to-end anastomosis vs other anastomotic configurations after resection in Crohn’s disease. Dis Colon Rectum 50:1674–1687CrossRefGoogle Scholar
  7. 7.
    Docherty JG, McGregor JR, Akyol AM, Murray GD, Galloway DJ, West of Scotland and Highland Anastomosis Study Group (1995) Comparison of manually constructed and stapled anastomoses in colorectal surgery. Ann Surg 221:176–184CrossRefGoogle Scholar
  8. 8.
    Kracht M, Hay J-M, Fagniez P-L, Fingerhut A (1993) Ileocolonic anastomosis after right hemicolectomy for carcinoma: stapled or hand-sewn? Int J Colon Dis 8:29–33CrossRefGoogle Scholar
  9. 9.
    MacRae HM, McLeod RS (1998) Handsewn vs stapled anastomoses in colon and rectal surgery: a meta-analysis. Dis Colon Rectum 41(2):180–189CrossRefGoogle Scholar
  10. 10.
    Choy PYG, Bisset IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A (2011) Stapled versus handsewn methods for ileocolic anastomoses (Review). Cochrane Database Syst Rev (9):CD004320.
  11. 11.
    Frasson M, Granero-Castro P, Ramos J, Flor-Lorente B, Braithwaite M, Martínez E, Álvarez J, Codina A, Espí A, García-Granero E (2016) Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients. Int J Color Dis 31:105–114CrossRefGoogle Scholar
  12. 12.
    Ibañez N, Abrisqueta J, Luján J, Hernández Q, Parrilla P (2017) Isoperistaltic versus antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy for cancer (ISOVANTI) trial: study protocol for a randomised clinical trial. Int J Color Dis 32:1349–1356CrossRefGoogle Scholar
  13. 13.
    Cirocchi R, Trastulli S, Farinella E, Guarino S, Desiderio J, Boselli C, Parisi A, Noya G, Slim K (2013) Intracorporeal versus extracorporeal anastomosis during laparoscopic right hemicolectomy – systematic review and meta-analysis. Surg Oncol 22:1–13CrossRefGoogle Scholar
  14. 14.
    Feroci F, Lenzi E, Garzi A, Vannucchi A, Cantafio S, Scatizzi M (2013) Inracorporeal versus extracorporeal anastomosis after laparoscopic right hemicolectomy for cancer: a systematic review and meta-analysis. Int J Color Dis 28:1177–1186CrossRefGoogle Scholar
  15. 15.
    Tarta C, Bishawi M, Bergamaschi R (2013) Intracorporeal ileocolic anastomosis: a review. Tech Coloproctol 17:479–485CrossRefGoogle Scholar
  16. 16.
    Carnuccio P, Jimeno J, Pares D (2014) Laparoscopic right colectomy: a systematic review and meta-analysis of observational studies comparing two types of anastomosis. Tech Coloproctol 18:5–12CrossRefGoogle Scholar
  17. 17.
    Wu Q, Jin C, Hu T, Wei M, Wang Z (2017) Intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy: a systematic review and meta-analysis. J Laparoendosc Adv Surg Tech A 27:348–357CrossRefGoogle Scholar
  18. 18.
    van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J (2017) Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc 31:64–77CrossRefGoogle Scholar
  19. 19.
    Marchesi F, Pinna F, Percalli L, Cecchini S, Ricco M, Costi R, Pattonieri V, Roncoroni L (2013) Totally laparoscopic right colectomy: theoretical and practical advantages over the laparo-assited approach. J Laparoendosc Adv Surg Tech A 23:418–424CrossRefGoogle Scholar
  20. 20.
    Vergis AS, Steigerwald SN, Bhojani FD, Sullivan PA, Hardy KM (2015) Laparoscopic right hemicolectomy with intracorporeal versus extracorporeal anastomosis: a comparison of short-term outcomes. Can J Surg 58:63–68CrossRefGoogle Scholar
  21. 21.
    Trastulli S, Coratti A, Guarino S, Piagnerelli R, Annecchiarico M, Coratti F, Di Marino M, Ricci F, Desiderio J, Cirocchi R, Parisi A (2015) Robotic right colectomy with intracorporeal anastomosis compared with laparoscopic right colectomy with extracorporeal and intracorporeal anastomosis: a retrospective multicenter study. Surg Endosc 29:1512–1521CrossRefGoogle Scholar
  22. 22.
    Anania G, Santini M, Scagliarini L, Marzetti A, Vedana L, Marino S, Gregorio C, Resta G, Cavallesco G (2012) A totally mini-invasive approach for colorectal laparoscopic surgery. World J Gastroenterol 18:3869–3874CrossRefGoogle Scholar
  23. 23.
    Chaves JA, Idoate CP, Fons JB, Oliver MB, Rodriguez NP, Delgado AB, Lizoain JLH (2011) A case-control study of extracorporeal versus intracorporeal anastomosis in patients subjected to right laparoscopic hemicolectomy. Cir Esp 89:24–30CrossRefGoogle Scholar
  24. 24.
    Kisielinski K, Conze J, Murken H, Lenzen NN, Klinge U, Schumpelick V (2004) The Pfannenstiel or so called “bikini cut”: still effective more than 100 years after first description. Hernia 8:177–181CrossRefGoogle Scholar
  25. 25.
    Singh R, Omiccioli A, Hegge S, McKinley C (2008) Does the extraction-site location in laparoscopic colorectal surgery have an impact on incisional hernia rates? Surg Endosc 22:2596–2600CrossRefGoogle Scholar
  26. 26.
    Winslow ER, Fleshman JW, Birnbaum EH, Blunt LM (2002) Wound complications of laparoscopic vs open colectomy. Surg Endosc 16:1420–1425CrossRefGoogle Scholar
  27. 27.
    Scatizzi M, Kroning KC, Borrelli A et al (2010) Extracorporeal versus intracorporeal anastomosis after laparoscopic right colectomy for cancer: a case-control study. World J Surg 34:2902–2908 21CrossRefGoogle Scholar
  28. 28.
    Roscio F, Bertoglio C, De Luca A et al (2012) Totally laparoscopic versus laparoscopic assisted right colectomy for cancer. Int J Surg 10:290–295 22CrossRefGoogle Scholar
  29. 29.
    Magistro C, Lernia SD, Ferrari G, Zullino A, Mazzola M, de Martini P, de Carli S, Forgione A, Bertoglio CL, Pugliese R (2013) Totally laparoscopic versus laparoscopic-assisted right colectomy for colon cancer: is there any advantage in short-term out- comes? A prospective comparative assessment in our center. Surg Endosc 27:2613–2618CrossRefGoogle Scholar
  30. 30.
    Hellan M, Anderson C, Pigazzi A (2009) Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS 13:312–317PubMedPubMedCentralGoogle Scholar
  31. 31.
    Lee KH, Ho J, Akmal Y, Nelson R, Pigazzi A (2013) Short- and long-term outcomes of intracorporeal versus extracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for colon cancer. Surg Endosc 27:1986–1990CrossRefGoogle Scholar
  32. 32.
    Franklin ME Jr, Gonzalez JJ Jr, Miter DB et al (2004) Laparoscopic right hemicolectomy for cancer: 11-year experience. Rev Gastroenterol Mex 69(Suppl 1):65–72 30PubMedGoogle Scholar
  33. 33.
    Milone M, Elmore U, Di Salvo E et al (2015) Intracorporeal versus extracorporeal anastomosis. results from a multicentre comparative study on 512 right-sided colorectal cancers. Surg Endosc 29:2314–2320CrossRefGoogle Scholar
  34. 34.
    Fabozzi M, Allieta R, Contul RB, Grivon M, Millo P, Lale-Murix E, Nardi M (2010) Comparison of short- and medium-term results between laparoscopically assisted and totally laparoscopic right hemicolectomy: a case-control study. Surg Endosc 24:2085–2091CrossRefGoogle Scholar
  35. 35.
    Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught C, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O, Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care, European Society for Clinical Nutrition and Metabolism (ESPEN), International Association for Surgical Metabolism and Nutrition (IASMEN) (2013) Guidelines for perioperative care in elective colonic surgery: enhanced recovery after surgery (ERAS((R))) society recommendations. World J Surg 37(2):259–284CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • J. Bollo
    • 1
    Email author
  • P. Salas
    • 1
  • M. C. Martinez
    • 1
  • P. Hernandez
    • 1
  • A. Rabal
    • 1
  • E. Carrillo
    • 1
  • E. Targarona
    • 1
  1. 1.Department of Medicine of the Autonomous University of BarcelonaHospital de la Santa Creu i Sant PauBarcelonaSpain

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