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

March 3, 2016 updated by: Institut Bergonié

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Institut Bergonié

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2008-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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