"High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial)

Giulio Mari, Dario Maggioni, Andrea Costanzi, Angelo Miranda, Luca Rigamonti, Jacopo Crippa, Carmelo Magistro, Stefano Di Lernia, Antonello Forgione, Pietro Carnevali, Michele Nichelatti, Pierluigi Carzaniga, Francesco Valenti, Marco Rovagnati, Mattia Berselli, Eugenio Cocozza, Lorenzo Livraghi, Matteo Origi, Ildo Scandroglio, Francesco Roscio, Antonio De Luca, Giovanni Ferrari, Raffaele Pugliese, Giulio Mari, Dario Maggioni, Andrea Costanzi, Angelo Miranda, Luca Rigamonti, Jacopo Crippa, Carmelo Magistro, Stefano Di Lernia, Antonello Forgione, Pietro Carnevali, Michele Nichelatti, Pierluigi Carzaniga, Francesco Valenti, Marco Rovagnati, Mattia Berselli, Eugenio Cocozza, Lorenzo Livraghi, Matteo Origi, Ildo Scandroglio, Francesco Roscio, Antonio De Luca, Giovanni Ferrari, Raffaele Pugliese

Abstract

Background: The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial.

Methods/design: The HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, β = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients.

Discussion: The HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function.

Trial registration: ClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014.

Figures

Figure 1
Figure 1
Study flowchart. LAR: Laparoscopic Anterior Resection. TME: Total Mesorectal Excision.

References

    1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61:69. doi: 10.3322/caac.20107.
    1. Brown G, Quirke P, Heald R, Moran B. A systematic review of cancer related patient outcomes after anterior resection and abdominoperineal excision for rectal cancer in the total mesorectal excision era. Surg Oncol. 2011;20(4):e149–55. doi: 10.1016/j.suronc.2011.05.001.
    1. Dedemadi G, Wexner SD. Complete response after neoadjuvant therapy in rectal cancer: to operate or not to operate? Dig Dis. 2012;30(Suppl 2):109–17. doi: 10.1159/000342039.
    1. Arezzo A, Passera R, Scozzari G, Verra M, Morino M. Laparoscopy for rectal cancer reduces short-term mortality and morbidity: results of a systematic review and meta-analysis. Surg Endosc. 2013;27(5):1485–502. doi: 10.1007/s00464-012-2649-x.
    1. Schwenk W, Haase O, Neudecker J. Short termbenefits for laparoscopic colorectal resection. Cochrane Database Syst Rev. 2005;20(3):CD003145.
    1. Kirzin S, Lo Dico R, Portier G, Pocard M. What is the established contribution of laparoscopy in the treatment of rectal cancer? J Visc Surg. 2012;149(6):371–9. doi: 10.1016/j.jviscsurg.2012.10.011.
    1. Knight CD, Griffen FD. An improved technique for low anterior resection of the rectum using the EEA stapler. Surgery. 1980;88:710–4.
    1. Cjeung YM, Lange MM, Buunen M, Lange JF. Current technique of laparoscopic total mesorectal excision (TME): an international questionnaire among 368 surgeons. Surg Endosc. 2009;23:2796–801. doi: 10.1007/s00464-009-0566-4.
    1. Cirocchi R, Trastulli S, Farinella E, Desiderio J, Vettoretto N, Parisi A, et al. High tie versus low tie of the inferior mesenteric artery in colorectal cancer: a RCT is needed. Surg Oncol. 2012;21(3):e111–23. doi: 10.1016/j.suronc.2012.04.004.
    1. Cirocchi R, Farinella E, Trastulli S, Desiderio J, Di Rocco G, Covarelli P, et al. High tie versus low tie of the inferior mesenteric artery: a protocol for a systematic review. World J Surg Oncol. 2011;9:147. doi: 10.1186/1477-7819-9-147.
    1. Hida J, Okuno K. High ligation of the inferior mesenteric artery in rectal cancer surgery. Surg Today. 2013;43:8–19. doi: 10.1007/s00595-012-0359-6.
    1. Buunen M, Lange MM, Ditzel M, Kleinrensink GJ, van de Velde CJ, Lange JF, et al. Level of arterial ligation in total mesorectal excision (TME): an anatomical study. Int J Colorectal Dis. 2009;24(11):1317–20. doi: 10.1007/s00384-009-0761-8.
    1. Bonnet S, Berger A, Hentati N, Abid B, Chevallier JM, Wind P, et al. High tie versus low tie vascular ligation of the inferior mesenteric artery in colorectal cancer surgery: impact on the gain in colon length and implications on the feasibility of anastomoses. Dis Colon Rectum. 2012;55(5):515–21. doi: 10.1097/DCR.0b013e318246f1a2.
    1. Wu JH, Rong ZX, Zhu DJ, Chen XW, Ren BJ. Laparoscopic anterior resection of rectal carcinoma with preservation of the left colonic artery. Nan Fang Yi Ke Da Xue Xue Bao. 2009;29(6):1249–50.
    1. Kang J, Hur H, Min BS, Kim NK, Lee KY. Prognostic impact of inferior mesenteric artery lymph node metastasis in colorectal cancer. Ann Surg Oncol. 2011;18(3):704–10. doi: 10.1245/s10434-010-1291-x.
    1. Uehara K, Yamamoto S, Fujita S, Akasu T, Moriya Y. Impact of upward lymph node dissection on survival rates in advanced lower rectal carcinoma. Dig Surg. 2007;24(5):375–81. doi: 10.1159/000107779.
    1. Chin CC, Yeh CY, Tang R, Changchien CR, Huang WS, Wang JY. The oncologic benefit of high ligation of the inferior mesenteric artery in the surgical treatment of rectal or sigmoid colon cancer. Int J Colorectal Dis. 2008;23(8):783–8. doi: 10.1007/s00384-008-0465-5.
    1. Ikeda Y, Shimabukuro R, Saitsu H, Saku M, Maehara Y. Influence of prophylactic apical node dissection of the inferior mesenteric artery on prognosis of colorectal cancer. Hepatogastroenterology. 2007;54(79):1985–7.
    1. Kim JC, Lee KH, Yu CS, Kim HC, Kim JR, Chang HM, et al. The clinicopathological significance of inferior mesenteric lymph node metastasis in colorectal cancer. Eur J Surg Oncol. 2004;30(3):271–9. doi: 10.1016/j.ejso.2003.12.002.
    1. Allison AS, Bloor C, Faux W, Arumugam P, Widdison A, Lloyd-Davies E, et al. The angiographic anatomy of the small arteries and their collaterals in colorectal resections: some insights into anastomotic perfusion. Ann Surg. 2010;251(6):1092–7. doi: 10.1097/SLA.0b013e3181deb649.
    1. Komen N, Slieker J, de Kort P, de Wilt JH, van der Harst E, Coene PP, et al. High tie versus low tie in rectal surgery: comparison of anastomotic perfusion. Int J Colorectal Dis. 2011;26(8):1075–8. doi: 10.1007/s00384-011-1188-6.
    1. Schmidt O, Merkel S, Hohenberger W. Anastomotic leakage after low rectal stapler anastomosis: significance of intraoperative anastomotic testing. Eur J Surg Oncol. 2003;29(3):239–43. doi: 10.1053/ejso.2002.1416.
    1. Chen CW, Chen MJ, Yeh YS, Tsai HL, Chang YT, Wang JY. Intraoperative anastomotic dye test significantly decreases incidence of anastomitic leaks in patients undergoing resection for rectal cancer. Tech Coloproctol. 2013;17(5):579–83. doi: 10.1007/s10151-012-0910-x.
    1. Jafari MD, Lee KH, Halabi WJ, Mills SD, Carmichael JC, Stamos MJ, et al. The use of indocyanine green fluorescence to assess anastomotic perfusion during robotic assisted laparoscopic rectal surgery. Surg Endosc. 2013;27(8):3003–8. doi: 10.1007/s00464-013-2832-8.
    1. Li VK, Wexner SD, Pulido N, Wang H, Jin HY, Weiss EG, et al. Use of routine intraoperative endoscopy in elective laparoscopic colorectal surgery: can it further avoid anastomotic failure? Surg Endosc. 2009;23(11):2459–65. doi: 10.1007/s00464-009-0416-4.
    1. Milsom JW, Pavoor RS, Shukla PJ. Evaluating the vascularity of intestinal anastomosis. Can narrow band imaging play a role? Med Hypotheses. 2011;77(2):290–3. doi: 10.1016/j.mehy.2011.04.038.
    1. Rosen RC1, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26.
    1. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322–30. doi: 10.1002/nau.20041.
    1. Jones LA. The use of validated questionnaires to assess female sexual dysfunction. World J Urol. 2002;20:89–92. doi: 10.1007/s00345-002-0268-1.
    1. National Comprehensive Cancer Network: Rectal Cancer/Surveillance, version 1.2015 []
    1. Lange MM, Buunen M, van de Velde CJ, Lange JF. Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A Rev Dis Colon Rectum. 2008;51(7):1139–45. doi: 10.1007/s10350-008-9328-y.

Source: PubMed

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