PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS

Study Overview
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Brief Summary
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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
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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.

Official Title
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PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Inferior mesenteric Vein dissection
* Procedure: Inferior mesenteric Artery dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males; 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: women Under 18 years old; Not Candidate for neoadjuvant (chemoradiotherapy); Emergency surgery; Recurrent neoplasms cT4 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inferior mesenteric Vein dissection<br>To improve and preserve the rectal nerve in the total mesorectal excision, its starts the dissection from the inferior mesenteric vein to the inferior mesenteric artery and through the pelvis | Procedure: Inferior mesenteric Vein dissection<br>* Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision<br>|
| Active Comparator: Inferior mesenteric Artery dissection<br>As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis | Procedure: Inferior mesenteric Artery dissection<br>* Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sexual dysfunction pre- and post-Total Mesorectal Excision | Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5 | 1 week before surgery and 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Sexual dysfunction, Urinary dysfunction, Rectal nerves damage, Total Mesorectal Excision