Back to resultsErectile Rating During the Treatment of Rectal Cancers Localized (METEORR)
Primary Purpose
Rectal Cancer Stage I
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of erectile dysfunction
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Cancer Stage I focused on measuring Localized rectal cancer in a male patient
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Institut Bergonié
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Register R
Arm Description
Evaluation of erectile dysfunction in the management of localized rectal cancer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01843218
Brief Title
Erectile Rating During the Treatment of Rectal Cancers Localized
Acronym
METEORR
Official Title
Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer Stage I
Keywords
Localized rectal cancer in a male patient
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Register R
Arm Type
Other
Arm Description
Evaluation of erectile dysfunction in the management of localized rectal cancer
Intervention Type
Other
Intervention Name(s)
Evaluation of erectile dysfunction
Intervention Description
Register R / P and self-administered questionnaire IIEF-5
Primary Outcome Measure Information:
Title
assess erectile dysfunction
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Evaluate objectively the presence of erectile dysfunction before and 12 months after the medico-surgical treatment of rectal cancer
Description
Describe objectively and qualitatively erectile dysfunction before and 3 and 12 months after the medico-surgical management.
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EVRARD Serge, PU-PH
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Erectile Rating During the Treatment of Rectal Cancers Localized
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