Coloproctology Unit, General and Digestive Surgery Department, Parc Taulí University Hospital, Sabadell, UniversitatAutònoma de Barcelona, Parc Taulí s/n. 08208 Sabadell, Barcelona, Spain.
Urology Department, Parc Taulí University Hospital, Sabadell, Universitat Autònoma de Barcelona, Parc Taulí s/n 08208, Sabadell, Barcelona, Spain.
BMC Urol. 2019 Aug 5;19(1):75. doi: 10.1186/s12894-019-0501-5.
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.
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.
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.
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).
全直肠系膜切除术（TME）是治疗直肠癌的标准手术技术。然而，TME 后性功能障碍的发生率高达 50%，尿功能障碍的发生率高达 30%。尽管还有其他因素参与，但术后泌尿生殖功能障碍的主要原因是术中盆自主神经损伤。肠系膜下动脉（IMA）的风险特别高。本研究的目的是比较 TME 前后的性功能障碍，取决于用于肠系膜下血管的手术方法：直接在 IMA 上，或从肠系膜下静脉（IMV）到 IMA。
前瞻性、随机、对照研究新辅助放化疗的直肠腺癌患者，将根据肠系膜下血管的手术方法随机分为两组。主要变量是 TME 前后的性功能障碍；次要变量是盆腔自主神经的可视化和保留、TME 前后的尿功能障碍以及 TME 前后的生活质量。样本将包括 90 例患者，每组 45 例。
目的是证明从 IMV 向 IMA 的解剖路径有利于保留盆腔自主神经，从而降低术后性功能障碍的发生率。
伦理和临床研究委员会，Parc Taulí 大学医院：注册号 017/315。ClinicalTrials.gov TAU-RECTALNERV-PRESERV-2018（TRN：NCT03520088）（注册日期：2018 年 3 月 4 日）。
