Erectile Rating During the Treatment of Rectal Cancers Localized

Rectal Cancer Stage I Clinical Trial

— METEORR  

Official title:

Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01843218
• Other study ID #: IB2008-07
• Status: Terminated
• Phase: N/A
• First received: November 6, 2012
• Last updated: March 3, 2016
• Start date: March 2008
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rectal Cancer Stage I
• Rectal Neoplasms

Intervention

Other:
• Evaluation of erectile dysfunction
Register R / P and self-administered questionnaire IIEF-5

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess erectile dysfunction	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.	1 day	No
Secondary	Evaluate objectively the presence of erectile dysfunction before and 12 months after the medico-surgical treatment of rectal cancer	Describe objectively and qualitatively erectile dysfunction before and 3 and 12 months after the medico-surgical management.	1 day	No

External Links

•   Registre des essais cliniques de l'INCa
•   Site internet du promoteur, l'Institut Bergonié