Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
18 Years
N/A
Male
Rectal Cancer Stage I
Trial Information
Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
assess erectile dysfunction
Outcome Description:
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.
Outcome Time Frame:
1 day
Safety Issue:
No
Principal Investigator
EVRARD Serge, PU-PH
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Bergonié
Authority:
France: Committee for the Protection of Personnes
Study ID:
IB2008-07
NCT ID:
NCT01843218
Start Date:
March 2008
Completion Date:
December 2014
Related Keywords:
- Rectal Cancer Stage I
- Localized rectal cancer in a male patient
- Rectal Neoplasms
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