Erectile Rating During the Treatment of Rectal Cancers Localized

Not Applicable

Terminated

• Conditions: Rectal Cancer Stage I
• Interventions: Other: Evaluation of erectile dysfunction

• Registration Number: NCT01843218
• Lead Sponsor: Institut Bergonié

Brief Summary

Erectile dysfunction will be explored by recording R / P and self-administered questionnaire IIEF-5.

Detailed Description

Erectile dysfunction will be explored by recording R / P and self-administered questionnaire IIEF-5. This dual evaluation will be made before the beginning of the therapeutic treatment and 3 months and 12 months after surgery. Assessed by IIEF-5 will be made only 6, 18 and 24 months after surgery. There will be no changes made to support oncology patients.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

1. Patients already treated for erectile dysfunction.
2. Absence of sexual activity before diagnosis.
3. Presence of secondary lesions at diagnosis (M +).
4. Classified T4 tumor preoperatively.
5. Surgery by laparotomy.
6. History of pelvic cancer surgery prostate or bladder.
7. History of pelvic radiotherapy (outside of the current process).
8. History of prostate or bladder neoplasia known.
9. Other neoplastic known.
10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Register R	Evaluation of erectile dysfunction	Evaluation of erectile dysfunction in the management of localized rectal cancer

Primary Outcome Measures

Name	Time	Method
assess erectile dysfunction	1 day	Evaluate objectively the presence of erectile dysfunction induced by medico-surgical treatment of rectal cancer three months after surgery. These objective data will be obtained using the Rigiscan ® PLUS system coupled to a polysomnogram. the investigators use the abbreviation Register R / P (Rigiscan ® PLUS / polysomonographie) in this protocol.

Secondary Outcome Measures

Name	Time	Method
Evaluate objectively the presence of erectile dysfunction before and 12 months after the medico-surgical treatment of rectal cancer	1 day	Describe objectively and qualitatively erectile dysfunction before and 3 and 12 months after the medico-surgical management.

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, Aquitaine, France