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

Corporacion Parc Tauli

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: Inferior mesenteric Vein dissection; Procedure: Inferior mesenteric Artery dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03520088

TAU-RECTALNERV-PRESERV-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Inferior mesenteric Vein dissection

Experimental group

Description:

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

Treatment:

Procedure: Inferior mesenteric Vein dissection

Inferior mesenteric Artery dissection

Active Comparator group

Description:

As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis

Treatment:

Procedure: Inferior mesenteric Artery dissection