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

Genital Prolapse Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901586
• Other study ID #: 2018_0072
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: November 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse

Intervention

Other:
• Satisfaction assessment
Patient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect
• Quality of life
The Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20)
• Gynecological assessment
An optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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")	4 months
Secondary	Long term anatomic impact of the procedure	An optional gynecological consult is proposed to the patients	7 months
Secondary	Post-operative complications	Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction	7 months