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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision

NCT05049317

Rectal Cancer

RECRUITING NA

Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Rectum Low Anterior Resection

NCT02746224

Colorectal Cancer Rectal Tumors

COMPLETED NA

Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer

NCT03107650

Rectal Cancer

COMPLETED

Selection of Surgical Technique in Rectal Cancer

NCT06442215

Rectal Neoplasms

RECRUITING

Patient Reported Outcomes Following Cancer of the Rectum

NCT04936581

Sphincter Ani Incontinence Rectal Cancer

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The analysis of the results will be blind for the investigator

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Inferior mesenteric Vein dissection

Intervention Type PROCEDURE

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

Inferior mesenteric Artery dissection

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

Group Type ACTIVE_COMPARATOR

Inferior mesenteric Artery dissection

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inferior mesenteric Vein dissection

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

Intervention Type PROCEDURE

Inferior mesenteric Artery dissection

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No