Pallisera-Lloveras et al. BMC Urology (2019) 19:75 https://doi.org/10.1186/s12894-019-0501-5 STUDY PROTOCOL Open Access 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-Lloveras1* , Paula Planelles-Soler2, Naim Hannaoui2, Laura Mora-López1, Jesús Muñoz-Rodriguez2, Sheila Serra-Pla1, Arturo Dominguez-Garcia2, Joan Prats-López2, Salvador Navarro-Soto1, Xavier Serra-Aracil1 and on behalf of Tauli-Colorectal Cancer Study Group 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, Total Mesorectal excision, Rectal cancer * Correspondence: apallill@gmail.com; apallisera@tauli.cat 1 Coloproctology Unit, General and Digestive Surgery Department, Parc Taulí University Hospital, Sabadell, UniversitatAutònoma de Barcelona, Parc Taulí s/n. 08208 Sabadell, Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 2 of 10 Background genitourinary dysfunction after TME surgery, with the pres- Despite the advances in adjuvant and neoadjuvant chemo- ervation of the pelvic autonomic nerves [8–10]. therapy (QT) and radiotherapy (RT) for colorectal cancer, In rectal cancer surgery particular attention must be surgery remains the only curative treatment [1]. Since its paid to certain areas, due to the risk of autonomic nerve first description by Heald in 1982 [2, 3], Total Mesorectal damage [6]. Figure 1 depicts the surgical anatomy of the Excision (TME) has been the standard surgical technique pelvic region and the key points where the risk of injury for the treatment of rectal cancer, and has brought about increases during surgery (Table 2) [5, 6, 11–14]. As de- significant improvement in oncological results in terms of scribed in the table, one of the regions with the highest both survival and local recurrence [4]. risk of injury is the inferior mesenteric artery (IMA). However, the literature describes post-TME rates of urin- Recently, Melani [15] described a new laparoscopic ap- ary dysfunction (urinary incontinence, difficulty in voiding proach for the release of the splenic flexure, in which a or neurogenic bladder) of up to 30% [5, 6]. The prevalence dissection of the mesenteric vessels is performed from of sexual dysfunction is above 50%; in men, it includeserec- the inferior mesenteric vein (IMV) to the IMA. This tile dysfunction and ejaculation problems, and in women, route presents a dissection plane that follows the ana- decreased vaginal lubrication, dyspareunia and difficulty tomical peritoneal sheets of the retroperitoneum and im- reaching orgasm [5, 6]. For this reason, the study of func- proves the visualization of the pelvic autonomic nerves tional results such as genitourinary function, fecal contin- from their origin. Compared with the standard approach ence and quality of life in general is taking on increasing to the inferior mesenteric vessels (i.e., directly on the importance [1]. IMA), we believe thatthe approach from the IMV to the Although other factors may be responsible for postopera- IMA will improve nerve preservation and thus reduce tive genitourinary dysfunction, the main cause is intraopera- the incidence of sexual and urinary dysfunction. tive injury to the pelvic autonomic nerves [1, 6]. This inadvertent lesion usually occurs due to a lack of anatomical Hypothesis and objectives knowledge or due to poor visualization of the nerves [6]. Hypothesis Minimally invasive techniques such as laparoscopic colorec- The hypothesis is that the dissection route from the tal surgery and robotic surgery have improved surgical tech- IMV to the IMA favors the preservation of the pelvic nique and surgical visibility, that helps in recognizing the autonomic nerves, and thus reduces genitourinary dys- inferior hypogastric plexus [7]. Moreover, a thorough ac- function in patients after laparoscopic TME. quaintance with anatomical reference points and experience ofthe dissection during TME reduces the risk of injuring the Objectives autonomic nerves, and leaves the mesorectal fascia intact. The main objective is to determine the pre- and post-TME Indeed, proficient TME technique helps to preserve the rates of sexual dysfunction in patients with rectal cancer ran- autonomic nerves, lowering the incidence of urinary dys- domly assigned to one of two nerve preservation techniques. function from 10 to 30% to 0–12% and sexual dysfunction In both groups, the secondary objectives are to assess: from 40 to 60% to 10–35% [5, 6]. Table 1 shows the urinary dysfunction pre- and post-TME; the visualization Table 1 Genitourinary dysfunction after TME surgery with preservation of the pelvic autonomic nerves Author (year) Surgical N Measurement Time of Urinary Sexual approach methods measurement dysfunction (%) dysfunction (%) Dulskas A, Open 108 Urinary: IPSS, BFLUTS Pre-IQ and Men 8.3% Men 27.8% et al. [1] Sexual: IIEF, FSFI 6 m postIQ Women 11.1% Women 11.1% (2016) Pontallier A, Lap 34 Urinary: IPSS 12 months after 23.5% 61% et al. [7] Sexual: IIEF, FSFI closure of the stoma (2016) Transanal 38 31.5% 29% Liu Z, Lap 518 Own scale At discharge and NE Ejaculation 42.5% et al. [8] 6 months postIQ Erection 41.9% (2016) Adam JP, Lap 169 Urinary: IPSS Pre-treatment, post-QTRT and 17% Men: et al. [9] Sexual: IIEF, FSFI 3,6 and 12 months postIQ Erection 43% (2016) Ejaculation 68% Women: Lubrication 62% Dyspareunia 42% Orgasm 57% TME total mesorectal excision, SP surgical procedure, IPSS International Prostatic Symptom Score, BFLUTS Bristol Female Lower Urinary Tract Symptoms, IIEF International Index of Erectile Function, FSFI Female Sexual Function Index. QTRT: chemoradiotherapy Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 3 of 10 Fig. 1 Outline of the pelvic autonomic nerves and their target organs and preservation of the superior hypogastric plexus rigid rectoscopy, candidate to TME; candidate for neo- (SHP), the hypogastric nerves, the inferior hypogastric adjuvant treatment (chemoradiotherapy); scheduled lap- plexus (IHP) and the Bundle of Walsh; and the impact aroscopic radical TME surgery carried out by colorectal of genitourinary dysfunction on patients’ quality of life. surgeons; ASA I, II or III; provision of signed informed consent. Methods/design Study design Exclusion criteria In this prospective, controlled randomized study of pa- Female sex; age under 18; not candidate for neoadjuvant tients undergoing laparoscopic TME for rectal cancer, treatment and/or adenocarcinoma > 10 cm from the anal with neoadjuvant chemoradiotherapy, patients will be verge candidate to partial TME; abdominoperineal resec- assigned to one of two groups, in a 1:1 ratio: the interven- tion (APR); emergency surgery; recurrent tumor; cT4; tion arm (dissection route from the IMV to the IMA), and history of infra-abdominal or pelvic prostate procedures; the control arm (dissection route directly to the IMA). radiotherapy prior to the current process; patients with severe sexual or urinary dysfunction before surgery; no Study area and participants provision of signed informed consent. The study will be carried out at the ParcTaulí University Hospital of Sabadell (Sabadell, Barcelona, Spain), which Criteria for withdrawal has a specialized unit for Colorectal Surgery, Urology, Patients who do not attend the subsequent follow-up. Radiodiagnosis, Oncology, and Radiotherapy. The study population will comprise patients diagnosed Definitions with rectal cancerundergoing total colonoscopy with multi- Sexual dysfunction (SD) is defined as difficulty at any focal biopsy, rectoscopy with endorectal ultrasound (ERUS), stage of sexual intercourse (which includes desire, pelvic magnetic resonance imaging (MRI) and thoraco- arousal, orgasm and resolution) that prevents the indi- abdominal computed tomography (CT). All patients will be vidual or their partner from enjoyingsexual activity [16]. evaluated by the multi-disciplinary committee of colorectal Erectile dysfunction (ED) is defined as the persistent in- tumors and must comply with the following criteria: ability to reach and maintain an erection sufficient to allow satisfactory sexual performance, which mayhave a Inclusion criteria physical and psychological effect on health and have a Male sex; age 18 years or over; diagnosis of rectal adeno- significant impact on the quality of life of patients and carcinoma ≤10 cm from the anal verge, measured by their respective partners [17]. Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 4 of 10 Table 2 Areas with risk of lesion in the main autonomic nerves, and their effects Nerve injured Area of risk Urinary dysf. Sexual dysf. SHP (sympathetic) Dissection and Stress urinary Retrograde ejaculation ligature of IMA incontinence Hypogastric nerves Posterior dissection Alteration in ejaculation (no alteration erection) Splanchnic nerves Rare in TME Neurogenic Men: alteration erection (parasympathetic) In radical lymph bladder Women: Dyspareunia node dissections IHP (mixed) Lateral dissection Incontinence Problems with ejaculation Difficulty voiding and erection - IHP one-sided Difficulty voiding Men: Ejaculation and erection problems Women: Problems with genital lubrication - IHP two-sided Bladder Men: impotence denervation Women: dyspareunia and ↓ability to reach orgasm Neurovascular bundle of Anterior dissection Men: impotencia and erectile Walsh and cavernous nerve dysfunction Women:dispareunia and reduced genital lubrication Pudendo nerve and levator ani Perineal stage of Urinary Sexual sensorial impotence Miles APR incontinence According to the 2017 European Association of Ur- (increased circumference, relatively rigid, but not enough ology (EAU) guidelines, the diagnostic evaluation should to achieve penetration); grade 3 or mild (increased be carried out with a correct anamnesis, the use ofvali- length and circumference to allow penetration, but not dated questionnaires such as the International Index of enough to be satisfactory); grade 4 (maximum dimen- Erectile Function or IIEF-5[18] and the Erection Hard- sions in terms of length and strength to achieve satisfac- ness Score (EHS) [19], a full physical examination and tory penetration) [19]. basic analytical parameters such as total testosterone Urinary or voiding dysfunction is defined as any alter- levels [17]. In addition, Doppler ultrasound of the penis ation in the correct functioning in the storage or periodic is recommended, with the aim of recording objective pa- emptying of urine, either in isolation or simultaneously rameters of induced erection so as to identify the cause [20]. To measure the severity of symptoms and the impact of ED [17]. on the quality of life, or to monitor the response to a par- The IIEF-5 questionnaire consists of five questions that ticular treatment, the ICIQ-SF (International Consultation are scored from 0 to 5. Scores of 21 or lower are consid- on Incontinence Questionnaire) is used [21]. The ICIQ-SF ered to indicateED. The test also classifies the severity of consists of three questions, with a total score of 1 to 21; a the ED as mild (score 17–21), mild to moderate (score score higher than 0 is considered a diagnosis of urinary 12–16), moderate 8–11 or severe (score 1–7) [18]. incontinence. The EHS classifies erections in four grades: grade 1 or The IPSS (International Prostate Syndrome Score) [22] severe (does not allow penetration); grade 2 or moderate consists of seven questions that assess voiding, frequency, Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 5 of 10 intermittency, urgency, weak stream and effort. Each Trial interventions question is scored from 0 to 5: an overall score of 1 to 7 Patients who meet the inclusion criteria and sign the in- reflects mild symptomatology, one from 8 to 19 moderate, formed consent document will be referred to the urolo- and from 20 to 35 severe. However, the only method that gist for functional study after 8–10 weeks of neoadjuvant can objectively evaluate the filling and emptying phase, treatment, before surgery (Fig. 2). and therefore diagnose the presence and type of urinary The study consists of: a) an anamnesis with medical and dysfunction, is the urodynamic study [20]. psychosexual history; b) total testosterone level (ng/dL); c) Erection Hardness Score (EHS) [19]; d)IIEF-5 [18];e) I- PSS [22]; f)ICIQ-SF [21]; g) the European Organization Informed consent and legal considerations for Research and Treatment of Cancer Quality-of-Life Patients will be informed, both orally and in writing, of questionnaire (EORTC-QLQ C30) [27]; h) Doppler ultra- the objective and duration of the study. It will be made sound of the penis; i) Urodynamic study. clear that participation is voluntary and they will be in- For the Doppler ultrasound of the penis, a baseline study formed of all the possible risks and associated complica- will be carried out to assess the ultrasound structure of the tions. Patients who meet the inclusion criteria and sign scrotal wall, both corpora cavernosa and the corpus spongi- informed consent will enter the randomization process. osum, the presence of calcifications or plaques of fibrosis, They may withdraw their consent to participate at any and their location. Subsequently, 15 mg of prostaglandin time. E1, a vasodilator agent that induces erection,will be applied The variables described are recorded in a computer- to one of the corpora cavernosa (the sidechosen for the in- ized database (Microsoft® Acces 2003). The data will be jection is irrelevant). After 20 min of the application the introduced in a protected format to avoid (as far as pos- ultrasound provides dorsal and transversal measurements sible) the entry of out-of-range or anomalous values. during the initial phases, and oblique-longitudinal measure- The patients’ data will berecorded anonymously and in ments once tumescence begins, of the diameter of both accordance with the Spanish legislation on data protec- cavernous arteries, their peak systolic flow velocity (cm/s) tion (LOPD, 1999) [23]. and their flow velocity at the end of diastole (cm/s) [28]. The study protocol, the patients’data and the informed For the urodynamic study a flowmetry will be per- consent documents have been approved by the Clinical formed, recording: maximum urine volume (mL), max- Research Ethics Committee in accordance with the 2015 imum flow (mL/s), average flow (mL/s), and urination Royal Decree on medical trials with drugs. The Parc time (s)) and subsequently an ultrasound evaluation of Taulí’s ethics committee will serve as the reference (ID: postvoid residue (mL) [20]. 2017/315). The study has been registered in the Clinical- Subsequently, patients undergo surgery after being Trials.gov database (ID: NCT03520088). randomly assigned to one of the two study arms. Before The trial will be carried out in accordance with the surgery, all patients will undergo mechanical colon prep- 7th Revision of the Declaration of Helsinki [24] and fol- aration with antibiotic and thromboembolic prophylaxis, lows the guidelines of the 2013 SPIRIT Standard Proto- in accordance with the center’s protocol. cols for Clinical Trials [25],CONSORT 2010 for Clinical Trials [26],and the Spanish Agency for Medicines and Surgical technique Health Medical Products). The surgery performed will be TME, using laparoscopic low anterior resection (LAR) approach or transanal TME (TaTME) [29], combining a laparoscopic approach Description of the randomization and Transanal endoscopic operation (TEO). A simple randomization system will be used, in which The surgery is performed only by 5 surgeons, who are the selected patients will be randomly assigned by a part of the colorectal unit. All of them experts in laparo- computer program in a 1:1 ratio to one of two study scopic surgery and they have training on both tech- arms: the intervention arm (dissection route from the niques (intervention and control arm). IMV to the IMA) and the control arm (dissection route The surgery is performed laparoscopically with the patient directly to the IMA). in the Lloyd-Davies position. If release and mobilization of the splenic angle is necessary the Melani technique is ap- plied [15], with the subsequent dissection of the IMA ac- Blinding cording to the randomization schedule, as follows: Neither the patient nor the urologist performing the sex- ual and urinary function study will have access to any a) Control group, with direct dissection of the IMA. surgical data; nor will they know which arm of the study Opening of the mesosigma peritoneum, laterally the patient belongs to. separating the SHP and hypogastric nerves. Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 6 of 10 Fig. 2 Proposed study schedule Visualization and preservation of the ureter, left In the case of laparoscopic LAR, a Pfannenstiel inci- primitive iliac vessels and the left gonadal vessels, sion is made toextract the specimen with the subsequent and maintaining Gerota’s fascia intact. High ligation mechanical end-to-end colorectal anastomosis with of the IMA is performed about 1.5-2 cm from its EEA™ Auto suture 28 (Covidien™, Dublin, Ireland). origin in the aorta. The medial-to-lateral dissection In transanal TME [29],TEO equipment is used (Karl proceeds, as far as the dissection of the splenic Storz GmbH, Tüttlingen, Germany), and a pouch is angle mobilization; made to close the distal rectum at least 1 cm below the b) Intervention group, with dissection of the IMV to the visualization of the lesion. The area of the sectionis IMA. Release of the splenic angle is followed by medial marked 1 cm from the pouch and transanal dissection of to lateral dissection from the IMV to the IMA, and a the mesorectal is carried out until reaching the dissec- high ligation is performed about 1.5-2 cm from its tion performed by laparoscopy. The lateral anterior dis- origin in the aorta. Subsequently, the dissection follows section continues, leaving the Denonvilliers fascia intact. the plane of the retroperitoneum from cranial to In the case of an end colostomy is required, a colostomy caudal and medial to lateral as far as the mesosigma. orifice is performed in a previously marked site, sectioning the proximal colon with a scalpel and performing an end The surgery continues with the following standardized colostomy, with placement of a prophylactic mesh using steps: opening of the left Told’s Fascia; mesorectal dis- the modified Sugarbaker technique [30, 31]. section immediately posterior to the superior rectal ar- tery, following the plane anterior to the presacral parietal fascia; bilateral dissection, avoiding traction and Follow-up blunt dissection that might damage the nerves or the in- The patient will be referred again to the urologist to re- tegrity of the mesorectum; the anterior dissection is per- peat the genitourinary dysfunction study 12 months after formed after completing the posterior dissection as far surgery: Doppler ultrasound of the penis, baseline flowme- as the pelvic floor, leaving the Denonvilliers fascia intact, try, EHS and the IIEF-5, I- PSS, ICIQ-SF and EORTC- and following the avascular plane. QLQ C30 questionnaires. Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 7 of 10 Study variables previous pelvic surgeries, previous radiotherapy, Briganti Main variable criteria (low /intermediate/high risk), total testosterone Preoperative, post-neoadjuvant and postoperative sexual levels (ng/dL). Characteristics of the tumor: height of the le- dysfunction at 12 months in all intervened patients will be sion (cm) by rectoscopy, location of the tumor (anterior, determined by the urologist, based on the results of the posterior, right or left lateral), cTNM staging. IIEF-5 questionnaire and/or Doppler ultrasound (peak sys- tolic velocity, tele-diastolic velocity and response to vasodila- Surgical Type of surgical technique (LAR, NOTES- tor agent). Scores of 21 or below on the IIEF-5 hybrid), surgical time. questionnaire will be taken to indicate sexual dysfunction. The ultrasound will confirm or rule out the presence of sex- Postoperative Morbidity at 30 days (according to the ual dysfunction generated by the test: an adequate response Clavien-Dindo classification [32]), 30-day mortality, CCI to thevasodilator agent, with blood flow above 35 cm/s in a [33], hospital stay. Definitive pathological anatomy: Size of patient with an altered IIEF-5 or EHS test will be considered the lesion (mm), pTNM and the completeness of mesor- a diagnostic criterion for ED of a neurogenic cause. ectal excision,according to the Quirke classification. Secondary variables Statistical analysis Sample size – Preoperative, post-neoadjuvant and postoperative With an α risk of 0.05 (5%), a one-sided hypothesis and erection hardness at 12 months; a βriskof 0.1 (power of 90%), taking into account that – Preoperative, post-neoadjuvant and postoperative the prevalence of post-TME sexual dysfunction is 50% urinary dysfunction at 12 months, determined based and intending to reduce the figure to 20%,it will be ne- on the results of the ICIQ-SF, IPSS and baseline cessary to include 41 patients in the two groups. Esti- flowmetry questionnaires (maximum urine volume, mating a possible loss to follow-up of 10%, the total maximum flow, mean flow and urination time) with sample required will be 90 patients: 45 per group. postvoid residue (mL). The presence of urinary In our hospital rectal surgery for cancer is expected dysfunction will be suspected if the patient has a between 60 and 70/year, with inclusion criteria, we think score of 1 or aboveon the ICIQ-SF questionnaire, a that about 45–50 could be included. That means, that score of 7 or above in the IPSS questionnaire or probabibly in two years, the recruitment should be alterations in the flowmetry parameters: a maximum finished. flow below 15 mL/s, a urinary volume less than 150 mL and/or a postvoid residue greater than 20% will be considered abnormal. Analysis of patients by intention to treat, per protocol, and – Quality of life post-neoadjuvancy and 12 months patients lost after surgery will be assessed using the EORTC Patients will be analysed by intention to treat (ITT), per QLQ-C30 questionnaire. protocol, andlost patients. – Visualization and preservation of the SHP, The intention to treat analysis will be applied to all hypogastric nerves, the IHP and the neurovascular randomized patients. bundle of Walsh, during surgery (for each of these The per protocol analysis will include part of the nerves), classified into: a) visualization and group in which direct dissection of the IMA is per- preservation of the nerves; b) visualization but no formed, and all the group that undergo dissection from preservation; c) no visualization. This variable will the IMV to the IMA. Statistical analysis of the lost pa- be determined by the surgical team that performs tients will be performed. the procedure. It will be taken into account that some patients may need the nerve resection for Monitoring oncological purposes. The intervention will be recorded Monitoring will be carried out by a data manager. The so that a surgeon not participating in the procedure can variables will be recorded on an Access database which classify the nerve injury, as described above, and the data manager will manage via the various hospitals. independently from the main surgeon. If there is disagreement between the two surgeons, the evaluation Statistical analysis of a third external reviewer will be requested. To evaluate the main objective of the study, the reduc- tion in sexual dysfunction achieved by the preservation Other variables of the pelvic autonomic nerves, we will use the method Preoperative: age (years), body mass index (BMI) (kg/m2), based on the one-sided confidence interval at 95% of the smoking (packets/year), Charlson comorbidity index (CCI), difference in sexual dysfunction between the two groups Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 8 of 10 [34, 35], in both the intention to treat and per protocol relationships with the physical and social environment samples. and with the community, and health objectively per- The quantitative variables will be described giving ceived”. As early as 1986, the European Organization for values of mean and standard deviation, or medians, Research and Treatment of Cancer (EORTC) launched a interquartile interval and range, as appropriate. The cat- program to assess the quality of life of patients partici- egorical variables will be described in absolute numbers pating in international clinical trials. This is why we have and percentages. chosen the questionnaire validated by this organization, The statistical analysis of the quantitative variables, the EORTC-QLQ C30 [27], to evaluate the quality of life with independent groups, will be performed with the in our study. parametric Student’s T-test, provided that its conditions Quality of life in our patients is defined by the need of application are met; otherwise, the non-parametric for an ostomy orby the presence ofsexual and urinary Mann-Whitney U test will be used. dysfunctions. Data on these dysfunctions are generally In the statistical analysis for categorical variables, the compiled through the use of questionnaires, which all Pearson Χ2 test or the Fisher exact test will be used. present subjective limitations. As described above, sexual These methods will be used to compare the baseline dysfunction is the difficulty at any stage of sexual inter- characteristicsof the two groups in order to assess course (including desire, arousal, orgasm and resolution) whether the randomization has been effective. that prevents the individual or their partner from enjoy- Statistical significance will be set at a p value of less ing sexual activity [5]. As detailed in the material and than 0.05. methods section, we have followed the indications of the EAU guidelines (2017) for the study of sexual dysfunc- Discussion tion. The reason for adding the Doppler ultrasound In our study, only men, submitted to TME and candi- study is to evaluate the cavernous arteries and their date for neoadjuvant treatment (chemoradiotherapy) are spectral evolution, in order to record objective parame- included, so that the sample is more homogeneous in ters of induced erection and thus to identify the cause of terms of final results. the erectile dysfunction [17]. In addition, there is no ref- TME, performed by minimally invasive surgery through erence in the literature of the study of SD in TME with laparoscopic or robotic approaches and/or TaTME, re- the Doppler and that will give us objective data about it. duces morbidity and accelerates postoperative recovery. Clearly, anxiety, psychological strain and any adrenergic Improved quality of life in the medium and long term stimulus may lead to false positive results, but with the continues to be one of the main objectives of TME. exception of these cases, an altered result can be attrib- Some authors have shown better functional results uted to a neurogenic cause of erectile dysfunction in pa- with the robotic approach due to the superior move- tients with a history of nerve damage [36]. Urinary ments of the wristed instruments that facilitate fine dis- dysfunction is defined as any alteration in the correct section, coupled with a stable and magnified view that functioning in the storage or periodic voiding of urine, ei- helps in recognizing the inferior hypogastric plexus [7]. ther in isolation or simultaneously. The tests used in the Due to the lack of experience in robotic surgery and our study are, once again, the ones recommended in the EAU long experience in laparoscopic surgery, the design of guidelines; however, the only method able to objectively our study has been made only in laparoscopic approach, evaluate the presence and type of urinary dysfunction is to avoid the learning curve bias. urodynamic study by means of flowmetry [20]. It is known, that quality of life and sexual dysfunction The rationale for our study is the belief that the dissec- rates are not similar among patients submitted to LAR tion routefrom the IMV to the IMA can improve nerve and APR. In our study, only patients submitted to LAR preservation of the nerves. The reason is anatomical, be- are included, in order to have a more homogeneous cause this approach route follows the plane of dissection sample. of the peritoneal sheets of the retroperitoneum, favoring Different definitions of the concept of “quality of life” visualization (and therefore a better preservation) of the have been proposed and perhaps no single definition is pelvic autonomic nerves from their origin. fully satisfactory. The best one may be: “a state of gen- We hope that our study will show that the approach eral satisfaction, derived from the realization of the po- from the IMV to the IMA can increase the preservation tential of the person. It has subjective aspects and of the pelvic autonomic nerves, and can thuslower the objective aspects. It is a subjective feeling of physical, rates of sexual dysfunctionto a figure around 20%. psychological and social well-being. It includes, as sub- In parallel, though this is not the objective of our jective aspects, intimacy, emotional expression, per- study, we believe that the detection of possible pre- ceived safety, personal productivity and objective health. surgical sexual dysfunction can promote prompt treat- As objective aspects, material well-being, harmonious ment of this dysfunction after surgery. Previous studies Pallisera-Lloveras et al. BMC Urology (2019) 19:75 Page 9 of 10 in the setting of prostate adenocarcinoma surgery have Consent for publication shown that the selection of the patient (according to age Not applicable. and preoperative sexual function, measured with the IIEF), as well as the surgical technique (in the case of Competing interests The authors declare that they have no competing interests. radical prostatectomies, the preservation of the neuro- vascular bundles) are the main determinants of postop- Author details 1 erative erectile function [37]. Correct stratification of Coloproctology Unit, General and Digestive Surgery Department, Parc Taulí University Hospital, Sabadell, UniversitatAutònoma de Barcelona, Parc Taulí s/n. patients is vital to patient assessment and to the selec- 08208 Sabadell, Barcelona, Spain. 2Urology Department, Parc Taulí University tion of the most appropriate postoperative treatment Hospital, Sabadell, Universitat Autònoma de Barcelona, Parc Taulí s/n 08208, strategy. These studies conclude that when patients are Sabadell, Barcelona, Spain. correctly stratified and selected, a high recovery rate of Received: 14 February 2019 Accepted: 18 July 2019 erectile function can be expected after radical prostatec- tomy with neurovascular preservation. If our hypothesis is supported, we believe that the References change in approach proposed here will help to improve 1. Dulskas A, Samalavicius NE. 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Digestive Department: assisted total mesorectal excision for rectal cancer: case-matched Eva Martinez-Bauer. comparison of short-term surgical and functional outcomes between the da E-mail addres of authors: Anna Pallisera-Lloveras (apallill@gmail.com), Paula Vinci xi and Si. Surg Endosc. 2018;32(2):589–600. Planelles-Soler (paula.planelles@gmail.com), Naim Hannaoui (NHannaoui@- 8. Pontallier A, Denost Q, Geluwe BV, Adam JP, Celerier B, Rullier E. Potential tauli.cat), Laura Mora-López (mora.lopez.laura@gmail.com), Jesús Muñoz- sexual function improvement by using transanal mesorectal approach for Rodriguez (JMUNOZR@tauli.cat), Sheila Serra-Pla (sheilaserrapla@gmail.com), laparoscopic low rectal cancer excision. SurgEndosc. 2016;30(11):4924–33. Arturo Dominguez-Garcia (arturodom1980@hotmail.com), Joan Prats-López 9. Liu Z, Huang M, Kang L, Wang L, Lan P, Cui J, Wang J. Prognosis and (JPrats@tauli.cat), Salvador Navarro-Soto (SNavarro@tauli.cat), Xavier Serra- postoperative genital function of function-preservative surgery of pelvic Aracil (xserraa@gmail.com). autonomic nerve preservation for male rectal cancer patients. BMC Surg. Tauli-Colorectal Cancer Study Group. Coloproctology Unit. General and 2016;16:12. Digestive Surgery Department: Anna Pallisera-Lloveras, Laura Mora-López, 10. Adam JP, Denost Q, Capdepont M, van Geluwe B, Rullier E. Prospective and Sheila Serra-Pla, Salvador Navarro-Soto, Xavier Serra-Aracil, Marta Hidalgo longitudinal study of urogenital dysfunction after proctectomy for rectal (mhidalgo@tauli.cat). 2Urology Department: Paula Planelles-Soler, Naim cancer. Dis Colon Rectum. 2016;59:822–30. Hannaoui, Jesús Muñoz-Rodriguez, Arturo Dominguez-Garcia, Joan Prats-López. 11. Havenga K, Grossmann I, DeRuiter M, Wiggers T. Definition of Total 3 Ostomy Nurse and Case Manager: Carmen Del Pino (CDelPino@tauli.cat). 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