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

Not Applicable

Completed

• Conditions: Genital Prolapse
• Interventions: Other: Satisfaction assessment; Other: Quality of life; Other: Gynecological assessment

• Registration Number: NCT03901586
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-12-01
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients who had Richter intervention	Satisfaction assessment	-
Patients who had Richter intervention	Quality of life	-
Patients who had Richter intervention	Gynecological assessment	-

Primary Outcome Measures

Name	Time	Method
Long-term satisfaction of the Richter procedure	4 months	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

Name	Time	Method
Long term anatomic impact of the procedure	7 months	An optional gynecological consult is proposed to the patients
Post-operative complications	7 months	Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France