Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial

Anna Pallisera-Lloveras, Paula Planelles-Soler, Naim Hannaoui, Laura Mora-López, Jesús Muñoz-Rodriguez, Sheila Serra-Pla, Arturo Dominguez-Garcia, Joan Prats-López, Salvador Navarro-Soto, Xavier Serra-Aracil, Tauli-Colorectal Cancer Study Group, Anna Pallisera-Lloveras, Laura Mora-López, Sheila Serra-Pla, Salvador Navarro-Soto, Xavier Serra-Aracil, Marta Hidalgo, Paula Planelles-Soler, Naim Hannaoui, Jesús Muñoz-Rodriguez, Arturo Dominguez-Garcia, Joan Prats-López, Carmen Del Pino, Carles Pericay, Ismael Macias, Eva Ballesteros, Àlex Casalots, Eva Martinez-Bauer, Anna Pallisera-Lloveras, Paula Planelles-Soler, Naim Hannaoui, Laura Mora-López, Jesús Muñoz-Rodriguez, Sheila Serra-Pla, Arturo Dominguez-Garcia, Joan Prats-López, Salvador Navarro-Soto, Xavier Serra-Aracil, Tauli-Colorectal Cancer Study Group, Anna Pallisera-Lloveras, Laura Mora-López, Sheila Serra-Pla, Salvador Navarro-Soto, Xavier Serra-Aracil, Marta Hidalgo, Paula Planelles-Soler, Naim Hannaoui, Jesús Muñoz-Rodriguez, Arturo Dominguez-Garcia, Joan Prats-López, Carmen Del Pino, Carles Pericay, Ismael Macias, Eva Ballesteros, Àlex Casalots, Eva Martinez-Bauer

Abstract

Background: Total Mesorectal Excision (TME) is the standard surgical technique for the treatment of rectal cancer. However, rates of sexual dysfunction ofup to 50% have been described after TME, and rates of urinary dysfunction of up to 30%. Although other factors are involved, the main cause of postoperative genitourinary dysfunction is intraoperative injury to the pelvic autonomic nerves. The risk is particularly high in the inferior mesenteric artery (IMA). The aim of this study is to compare pre- and post-TME sexual dysfunction, depending on the surgical approach usedin the inferior mesenteric vessels: either directly on the IMA, or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Prospective, randomized,controlled study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomly assigned to one of two groups depending on the surgical approach to the inferior mesenteric vessels. The main variable is pre- and postoperative sexual dysfunction; secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, and pre- and postoperative quality of life. The sample will comprise 90 patients, 45 per group.

Discussion: The aim is to demonstrate that the dissection route from the IMV towards the IMA favors the preservation of the pelvic autonomic nerves and thus reducesrates of sexual dysfunction post-surgery.

Trial registration: Ethical and Clinical Research Committee, Parc Taulí University Hospital: ID 017/315. ClinicalTrials.gov TAU-RECTALNERV-PRESERV-2018 (TRN: NCT03520088 ) (Date of registration 04/03/2018).

Keywords: Genitourinary dysfunction; Injury to the pelvic autonomic nerves; Rectal cancer; Total Mesorectal excision.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Outline of the pelvic autonomic nerves and their target organs
Fig. 2
Fig. 2
Proposed study schedule

References

    1. Dulskas A, Samalavicius NE. A prospective study of sexual and urinary function before and after total mesorectal excision. Int J Color Dis. 2016;31:1125–1130. doi: 10.1007/s00384-016-2549-y.
    1. Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery-the clue to pelvic recurrence? Br J Surg. 1982;69:613–616. doi: 10.1002/bjs.1800691019.
    1. Heald RJ. The “holy plane” of rectal surgery. J R Soc Med. 1988;81:503–508. doi: 10.1177/014107688808100904.
    1. Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cáncer. Lancet. 1986;1(8496):1479–1482. doi: 10.1016/S0140-6736(86)91510-2.
    1. Dulskas A, Miliauskas P, Tikuisis R, Escalante R, Samalavicius NE. The functional results of radical rectal cancer surgery: review of the literature. Acta Chir Belg. 2016;116:1–10. doi: 10.1080/00015458.2015.1136482.
    1. Kim NK, Kim YW, Cho MS. Total mesorectal excision for rectal cancer with emphasis on pelvic autonomic nerve preservation: expert technical tips for robotic surgery. Surg Oncol. 2015;24(3):172–180. doi: 10.1016/j.suronc.2015.06.012.
    1. Morelli L, Di Franco G, Guadagni S, Rossi L, Palmeri M, Furbetta N, Gianardi D, Bianchini M, Caprili G, D'Isidoro C, Mosca F, Moglia A, Cuschieri A. Robot-assisted total mesorectal excision for rectal cancer: case-matched comparison of short-term surgical and functional outcomes between the da Vinci xi and Si. Surg Endosc. 2018;32(2):589–600. doi: 10.1007/s00464-017-5708-5.
    1. Pontallier A, Denost Q, Geluwe BV, Adam JP, Celerier B, Rullier E. Potential sexual function improvement by using transanal mesorectal approach for laparoscopic low rectal cancer excision. SurgEndosc. 2016;30(11):4924–4933.
    1. Liu Z, Huang M, Kang L, Wang L, Lan P, Cui J, Wang J. Prognosis and postoperative genital function of function-preservative surgery of pelvic autonomic nerve preservation for male rectal cancer patients. BMC Surg. 2016;16:12. doi: 10.1186/s12893-016-0127-4.
    1. Adam JP, Denost Q, Capdepont M, van Geluwe B, Rullier E. Prospective and longitudinal study of urogenital dysfunction after proctectomy for rectal cancer. Dis Colon Rectum. 2016;59:822–830. doi: 10.1097/DCR.0000000000000652.
    1. Havenga K, Grossmann I, DeRuiter M, Wiggers T. Definition of Total Mesorectal excision, including the perineal phase: technical considerations. Dig Dis. 2007;25:44–50. doi: 10.1159/000099169.
    1. Chew MH, Yeh YT, Lim E, Seow-Choen F. Pelvic autonomic nerve preservation in radical rectal cancer surgery: changes in the past 3 decades. Gastroenterol Rep. 2016;4(3):173–185. doi: 10.1093/gastro/gow023.
    1. Moszkowicz D, Alsaid B, Bessede T, Penna C, Nordlinger B, Benoît G, Peschaud F. Where does pelvic nerve injury occur during rectal surgery for cancer? Color Dis. 2011;13(12):1326–1334. doi: 10.1111/j.1463-1318.2010.02384.x.
    1. Clausen N, Wolloscheck T, Konerding MA. How to optimize autonomic nerve preservation in total mesorectal excision: clinical topography and morphology of pelvic nerves and fasciae. World J Surg. 2008;32:1768–1775. doi: 10.1007/s00268-008-9625-6.
    1. Komolafe OO, Melani AG, Véo CA, Denadai MV, de Oliveira JC. Laparoscopic mobilization for resection of the transverse colon for cancer: a simple, reproducible method. Surg Laparosc Endosc Percutan Tech. 2012;22(5):e267–e270. doi: 10.1097/SLE.0b013e318264952e.
    1. López-Ibor J. DSM-IV-TR: diagnostic and statistical manual of mental disorders. San Francisco: American Psychiatric Association; 2013. pp. 600–603.
    1. Salonia A, Eardley I, Giuliano F, Hatzichristou D, Moncada I, Vardi Y, Wespes E, Hatzimouratidis K, European Association of Urology European Association of Urology guidelines on priapism. Eur Urol. 2014;65:480–489. doi: 10.1016/j.eururo.2013.11.008.
    1. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–830. doi: 10.1016/S0090-4295(97)00238-0.
    1. Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the erectionhardnessscore. J Sex Med. 2007;4:1626–1634. doi: 10.1111/j.1743-6109.2007.00600.x.
    1. Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2006;69:324–333. doi: 10.1016/j.eururo.2015.07.071.
    1. Bright E, Cotterill N, Drake M, Abrams P. Developing and validating the InternationalConsultation on IncontinenceQuestionnaire bladder diary. Eur Urol. 2014;66(2):294–300. doi: 10.1016/j.eururo.2014.02.057.
    1. Barry MJ, Fowler FJ, Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American urological association symptom index for benign prostatic hyperplasia. The measurement Committee of the American Urological Association. J Urol. 1992;148:1549–1557. doi: 10.1016/S0022-5347(17)36966-5.
    1. Ley orgánica 15/1999 de 13 de diciembre de protección de datos de carácter personal (LOPD). BOE n° 298 de 14 /12/1999.
    1. Emanuel EJ. Reconsidering the declaration of Helsinki. Lancet. 2013;381:1532–1533. doi: 10.1016/S0140-6736(13)60970-8.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: definingstandardprotocolitemsforclinicaltrials. Ann InternMed. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Schulz KF, Altman DG, Moher D, for the CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9:672–677. doi: 10.1016/j.ijsu.2011.09.004.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes CJ, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–376. doi: 10.1093/jnci/85.5.365.
    1. Sarteschi LM, Montorsi F, MenchiniFabris F, Guazzoni G, Lencioni R, Rigatti P. Cavernous arterial and arteriolar circulation in patients with erectile dysfunction: a power Doppler study. J Urol. 1998;159:428–432. doi: 10.1016/S0022-5347(01)63941-7.
    1. Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO fortransanal total mesorectalexcision: intracorporealresection and anastomosis. Surg Endosc. 2016;30:346–354. doi: 10.1007/s00464-015-4170-5.
    1. Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009;249:583–587. doi: 10.1097/SLA.0b013e31819ec809.
    1. López-Cano M, Serra-Aracil X, Mora L, Sánchez-García JL, Jiménez-Gómez LM, Martí M, Vallribera F, Fraccalvieri D, Serracant A, Kreisler E, Biondo S, Espín E, Navarro-Soto S, Armengol-Carrasco M. Preventing Parastomal hernia using a modified Sugarbaker technique with composite mesh during laparoscopic abdominoperineal resection: a randomized controlled trial. Ann Surg. 2016;264:923–928. doi: 10.1097/SLA.0000000000001684.
    1. Dindo D, Demartines N, Clavien P-A. Classification of surgical complications. A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2014;240:205–213. doi: 10.1097/.
    1. Slankamenac K, Graf R, Barkun J, et al. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013;258:1–7. doi: 10.1097/SLA.0b013e318296c732.
    1. Kaul S, Diamond GA. Goodenough: a primer ontheanalysis and interpretation of noninferioritytrials. Ann InternMed. 2006;4(145):62–69. doi: 10.7326/0003-4819-145-1-200607040-00011.
    1. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, CONSORT group Reporting of noninferiority and equivalencerandomizedtrials: anextension of the CONSORT statement. JAMA. 2006;295:1152–1160. doi: 10.1001/jama.295.10.1152.
    1. de la Torre HP, Hernández Jover D, Martí Malet J, Ochoteco García JI. Valoración de la Disfunción Eréctil mediante ecografía Doppler-Duplex. ArchEspUrol. 2001;54:617–625.
    1. Briganti A, Gallina A, Suardi N, Capitanio U, Tutolo M, Bianchi M, Passoni N, Salonia A, Colombo R, Di Girolamo V, Guazzoni G, Rigatti P, Montorsi F. Predicting erectile function recovery after bilateral nerve sparing radical prostatectomy: a proposal of a novel preoperative risk stratification. J Sex Med. 2010;7:2521–2531. doi: 10.1111/j.1743-6109.2010.01845.x.

Source: PubMed

3
订阅