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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Procedure: Inferior mesenteric Vein dissection; Procedure: Inferior mesenteric Artery dissection

• Registration Number: NCT03520088
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25
• Study Start: 2018-09-03
• Primary Completion: 2021-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inferior mesenteric Vein dissection	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
Inferior mesenteric Artery dissection	Inferior mesenteric Artery dissection	As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis

Primary Outcome Measures

Name	Time	Method
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision	1 week before surgery and 12 months post-surgery	Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5

Trial Locations

Locations (1)

Parc Tauli University Hospital; 🇪🇸 Sabadell, Barcelona, Spain