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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03520088
Enrollment
90
Registered
2018-05-09
Start date
2018-09-03
Completion date
2022-12-30
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

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

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.

Interventions

PROCEDUREInferior mesenteric Vein dissection

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

PROCEDUREInferior mesenteric Artery dissection

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The analysis of the results will be blind for the investigator

Eligibility

Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision1 week before surgery and 12 months post-surgerySexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5

Countries

Spain

Contacts

Primary ContactAnna Pallisera-Lloveras, MD, PhD
apallill@gmail.com34-93-723-1010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026