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Brief Title: PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
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
Study ID: NCT03520088
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Parc Tauli University Hospital, Sabadell, Barcelona, Spain
Name: Anna Pallisera-Lloveras, MD, PhD
Affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
Role: PRINCIPAL_INVESTIGATOR