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Trial record 48 of 1547 for:    rectal cancer

Erectile Rating During the Treatment of Rectal Cancers Localized (METEORR)

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ClinicalTrials.gov Identifier: NCT01843218
Recruitment Status : Terminated
First Posted : April 30, 2013
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Stage I Other: Evaluation of erectile dysfunction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
Study Start Date : March 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

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Arm Intervention/treatment
Register R
Evaluation of erectile dysfunction in the management of localized rectal cancer
Other: Evaluation of erectile dysfunction
Register R / P and self-administered questionnaire IIEF-5




Primary Outcome Measures :
  1. assess erectile dysfunction [ Time Frame: 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 :
  1. Evaluate objectively the presence of erectile dysfunction before and 12 months after the medico-surgical treatment of rectal cancer [ Time Frame: 1 day ]
    Describe objectively and qualitatively erectile dysfunction before and 3 and 12 months after the medico-surgical management.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843218


Locations
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France
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Sponsors and Collaborators
Institut Bergonié
Investigators
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Study Chair: EVRARD Serge, PU-PH Institut Bergonié

Additional Information:
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01843218     History of Changes
Other Study ID Numbers: IB2008-07
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Institut Bergonié:
Localized rectal cancer in a male patient
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases