Rectal Cancer Clinical Trial
Official title:
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the
treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to
30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME
sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on
the IMA or from the inferior mesenteric vein (IMV) to the IMA.
Methods: Multicenter, prospective, controlled and randomized study of patients with rectal
adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups
depending on the approach of the inferior mesenteric vessels. The main variable is pre and
postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per
group.
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the
treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to
30% of urinary dysfunction. Although there are other factors, the main cause of postoperative
genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. One of the
regions with more risk is the Inferior Mesenteric Artery (IMA). The main objective of the
study is to compare pre- and post-TME sexual dysfunction according to the approach of the
inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV)
to the IMA.
Methods: Multicenter, prospective, controlled and randomized study of patients with rectal
adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups
depending on the approach of the inferior mesenteric vessels. The main variable is pre and
postoperative sexual dysfunction. The secondary variables are visualization and preservation
of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and
postoperative quality of life. The sample to be included will be 90 patients, 45 per group.
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