Clinical trial · Interventional
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inferior mesenteric Artery dissection | Procedure | — | UNRESOLVED |
| Inferior mesenteric Vein dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Inferior mesenteric Vein dissection
- description
- 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
- interventionNames
- Procedure: Inferior mesenteric Vein dissection
- type
- ACTIVE_COMPARATOR
- label
- Inferior mesenteric Artery dissection
- description
- As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis
- interventionNames
- Procedure: Inferior mesenteric Artery dissection
Primary outcomes (1)
- measure
- Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPallisera-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. PMID 31382934