Clinical trial NCT03520088: PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal cancer
Sexual dysfunction
Urinary dysfunction
Rectal nerves damage
Total Mesorectal Excision
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Paula Planelles-Soler
name: Laura Mora-Lopez
name: Naim Hannaoui
name: Sheila Serra-Pla
name: Arturo Dominguez-Garcia
name: Jesus Muñoz-Rodriguez
name: Joan Prats-Lopez
name: Salvador Navarro-Soto
name: Xavier Serra-Aracil
First posted: 2018-05-09
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
timeFrame: 1 week before surgery and 12 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli University Hospital
state: Barcelona
Study officials:
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
name: Anna Pallisera-Lloveras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.