Back to resultsSatisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008 (RICHTER)
Primary Purpose
Genital Prolapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Satisfaction assessment
Quality of life
Gynecological assessment
Sponsored by
About this trial
This is an interventional other trial for Genital Prolapse
Eligibility Criteria
Inclusion Criteria:
- Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital
Exclusion Criteria:
- None
Sites / Locations
- Hôpital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients who had Richter intervention
Arm Description
Outcomes
Primary Outcome Measures
Long-term satisfaction of the Richter procedure
It will be ask to the patients to evaluate their satisfaction of the procedure, base on a 4-answer scale ("Not at all satisfied", "Not very satisfied", "Moderately satisfied", "Fully satisfied")
Secondary Outcome Measures
Long term anatomic impact of the procedure
An optional gynecological consult is proposed to the patients
Post-operative complications
Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03901586
Brief Title
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
Acronym
RICHTER
Official Title
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.
Detailed Description
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Prolapse
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients who had Richter intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Satisfaction assessment
Intervention Description
Patient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect
Intervention Type
Other
Intervention Name(s)
Quality of life
Intervention Description
The Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20)
Intervention Type
Other
Intervention Name(s)
Gynecological assessment
Intervention Description
An optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure
Primary Outcome Measure Information:
Title
Long-term satisfaction of the Richter procedure
Description
It will be ask to the patients to evaluate their satisfaction of the procedure, base on a 4-answer scale ("Not at all satisfied", "Not very satisfied", "Moderately satisfied", "Fully satisfied")
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Long term anatomic impact of the procedure
Description
An optional gynecological consult is proposed to the patients
Time Frame
7 months
Title
Post-operative complications
Description
Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction
Time Frame
7 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeline Favre-Inhofer
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Marc Ayoubi
Organizational Affiliation
Hôpital Foch
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
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