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

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.

Conditions

• Rectal Cancer

Interventions

PROCEDURE

Inferior mesenteric Vein dissection

Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision

PROCEDURE

Inferior mesenteric Artery dissection

Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision

Sponsors & Collaborators

• Paula Planelles-Soler

  collaborator UNKNOWN

• Laura Mora-Lopez

  collaborator UNKNOWN

• Naim Hannaoui

  collaborator UNKNOWN

• Sheila Serra-Pla

  collaborator UNKNOWN

• Arturo Dominguez-Garcia

  collaborator UNKNOWN

• Jesus Muñoz-Rodriguez

  collaborator UNKNOWN

• Joan Prats-Lopez

  collaborator UNKNOWN

• Salvador Navarro-Soto

  collaborator UNKNOWN

• Xavier Serra-Aracil

  collaborator UNKNOWN

• Corporacion Parc Tauli

  lead OTHER

Principal Investigators

• Anna Pallisera-Lloveras, MD, PhD · Corporacio Parc Tauli. Parc Tauli University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-03

Primary Completion

2021-12-30

Completion

2022-12-30

Countries

• Spain

Study Locations