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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03520088
• Other study ID #: TAU-RECTALNERV-PRESERV-2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2018
• Source: Corporacion Parc Tauli
• Contact: Anna Pallisera-Lloveras, MD, PhD
• Phone: 34-93-723-1010
• Email: apallill[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Inferior mesenteric Vein dissection
Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision
• Inferior mesenteric Artery dissection
Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision

Locations

Country	Name	City	State
Spain	Parc Tauli University Hospital	Sabadell	Barcelona

Sponsors (10)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Arturo Dominguez-Garcia, Jesus Muñoz-Rodriguez, Joan Prats-Lopez, Laura Mora-Lopez, Naim Hannaoui, Paula Planelles-Soler, Salvador Navarro-Soto, Sheila Serra-Pla, Xavier Serra-Aracil

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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