Erectile Rating During the Treatment of Rectal Cancers Localized

NCT01843218 | Completed Results

• 1 other identifier: IB2008-07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. Aim : Objectively assess the presence of erectile dysfunction induced by medical and surgical treatment of rectal cancer three months after surgery. These objective data will be obtained using the RIGISCAN® PLUS system coupled with polysomnographic recording.

Conditions

Rectal Cancer Stage I

Keywords

Localized rectal cancer in a male patient

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer

  Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)

  3 months after surgery

Secondary Outcomes (1)

• Quality of Nocturnal Erections

  3 years after surgery

Study Arms (1)

Patients with localized rectal cancer

OTHER

Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)

Other: Evaluation of erectile dysfunction

Interventions

Evaluation of erectile dysfunction OTHER

Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)

Patients with localized rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient.
• Age greater than 18 years.
• Neoplastic rectal stage ≤ T3.
• Patient sexually active before diagnosis.
• Laparoscopic surgery.
• Medico-surgical institute Bergonié.
• Patient information and consent for participation in the study.

You may not qualify if:

• Patients already treated for erectile dysfunction.
• Absence of sexual activity before diagnosis.
• Presence of secondary lesions at diagnosis (M +).
• Classified T4 tumor preoperatively.
• Surgery by laparotomy.
• History of pelvic cancer surgery prostate or bladder.
• History of pelvic radiotherapy (outside of the current process).
• History of prostate or bladder neoplasia known.
• Other neoplastic known.
• Patient for psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patient deprived of liberty or under guardianship.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• EVRARD Serge, PU-PH

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: April 30, 2013
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 23, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)