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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

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ClinicalTrials.gov Identifier: NCT03520088
Recruitment Status : Not yet recruiting
First Posted : May 9, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Paula Planelles-Soler
Laura Mora-Lopez
Naim Hannaoui
Sheila Serra-Pla
Arturo Dominguez-Garcia
Jesus Muñoz-Rodriguez
Joan Prats-Lopez
Salvador Navarro-Soto
Xavier Serra-Aracil
Information provided by (Responsible Party):
Anna Pallisera-Lloveras, Corporacion Parc Tauli

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Inferior mesenteric Vein dissection Procedure: Inferior mesenteric Artery dissection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The analysis of the results will be blind for the investigator
Primary Purpose: Prevention
Official Title: PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
Estimated Study Start Date : September 3, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male. The main objective of the study is asses the sexual dysfunction in male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520088


Contacts
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Contact: Anna Pallisera-Lloveras, MD, PhD 34-93-723-1010 ext 21490 apallill@gmail.com

Locations
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Spain
Parc Tauli University Hospital Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Anna Pallisera-Lloveras, MD,PhD    93-723-1010 ext 21490    apallill@gmail.com   
Contact: Xavier Serra-Aracil, MD,PhD    93-723-1010 ext 21490    xserraa@gmail.com   
Sponsors and Collaborators
Corporacion Parc Tauli
Paula Planelles-Soler
Laura Mora-Lopez
Naim Hannaoui
Sheila Serra-Pla
Arturo Dominguez-Garcia
Jesus Muñoz-Rodriguez
Joan Prats-Lopez
Salvador Navarro-Soto
Xavier Serra-Aracil
Investigators
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Principal Investigator: Anna Pallisera-Lloveras, MD, PhD Corporacio Parc Tauli. Parc Tauli University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Pallisera-Lloveras, md, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03520088     History of Changes
Other Study ID Numbers: TAU-RECTALNERV-PRESERV-2018
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Pallisera-Lloveras, Corporacion Parc Tauli:
Rectal cancer
Sexual dysfunction
Urinary dysfunction
Rectal nerves damage
Total Mesorectal Excision
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases