PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
Overview
- Phase
- Not Applicable
- Sponsor
- Corporacion Parc Tauli
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The analysis of the results will be blind for the investigator
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater (or equal) to 18 years
- •Diagnosed of rectal adenocarcinoma at ≤ 15 cm from the anal margin (by rigid rectoscopy)
- •Candidate for neoadjuvant (chemoradiotherapy).
- •Scheduled laparoscopic radical TME surgery carried out by colorectal surgeons;
- •ASA I, II or III;
- •Informed consent present.
Exclusion Criteria
- •Under 18 years old;
- •Not Candidate for neoadjuvant (chemoradiotherapy);
- •Emergency surgery;
- •Recurrent neoplasms
- •Patient with a history of infra-abdominal, or pelvic surgery of the prostate, or radiotherapy prior to the current process;
- •Patients with severe sexual dysfunction and neurological alterations before surgery
- •Patients with neurogenic bladder before surgery.
- •Not to sign the informed consent
Outcomes
Primary Outcomes
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Time Frame: 1 week before surgery and 12 months post-surgery
Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5
Secondary Outcomes
No secondary outcomes reported
Investigators
Anna Pallisera-Lloveras
md, PhD
Corporacion Parc Tauli