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

NCT03520088 | Unknown

• 1 other identifier: TAU-RECTALNERV-PRESERV-2018
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Sexual dysfunction; Urinary dysfunction; Rectal nerves damage; Total Mesorectal Excision

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Inferior mesenteric Vein dissection

EXPERIMENTAL

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

Inferior mesenteric Artery dissection

ACTIVE COMPARATOR

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

Procedure: Inferior mesenteric Artery dissection

Interventions

Inferior mesenteric Vein dissection PROCEDURE

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

Inferior mesenteric Vein dissection

Inferior mesenteric Artery dissection PROCEDURE

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

Inferior mesenteric Artery dissection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male. The main objective of the study is asses the sexual dysfunction in male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Paula Planelles-Soler: collaborator
• Laura Mora-Lopez: collaborator
• Naim Hannaoui: collaborator
• Sheila Serra-Pla: collaborator
• Arturo Dominguez-Garcia: collaborator
• Jesus Muñoz-Rodriguez: collaborator
• Joan Prats-Lopez: collaborator
• Salvador Navarro-Soto: collaborator
• Xavier Serra-Aracil: collaborator

Study Sites (1)

Parc Tauli University Hospital

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• Pallisera-Lloveras A, Planelles-Soler P, Hannaoui N, Mora-Lopez L, Munoz-Rodriguez J, Serra-Pla S, Dominguez-Garcia A, Prats-Lopez J, Navarro-Soto S, Serra-Aracil X; Tauli-Colorectal Cancer Study Group. Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial. BMC Urol. 2019 Aug 5;19(1):75. doi: 10.1186/s12894-019-0501-5.

  PMID: 31382934 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Anna Pallisera-Lloveras, MD, PhD

  Corporacio Parc Tauli. Parc Tauli University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Pallisera-Lloveras, MD, PhD

CONTACT

34-93-723-1010; apallill@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analysis of the results will be blind for the investigator
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md, PhD

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: May 9, 2018
• Study Start: September 3, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

ES (1)