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

June 21, 2018 updated by: Anna Pallisera-Lloveras, Corporacion Parc Tauli

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Parc Tauli University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inferior mesenteric Vein dissection
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
Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision
Active Comparator: Inferior mesenteric Artery dissection
As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis
Procedure: Inferior mesenteric Artery dissection
Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week before surgery and 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Collaborators

Sheila Serra-Pla
Laura Mora-Lopez
Paula Planelles-Soler
Naim Hannaoui
Arturo Dominguez-Garcia
Jesus Muñoz-Rodriguez
Joan Prats-Lopez
Salvador Navarro-Soto
Xavier Serra-Aracil

Investigators

  • Principal Investigator: Anna Pallisera-Lloveras, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 3, 2018

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAU-RECTALNERV-PRESERV-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on Inferior mesenteric Vein dissection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe