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 (RICHTER)

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 Overview

• Status: Completed
• Conditions: Genital Prolapse
• Intervention / Treatment: Other: Satisfaction assessment; Other: Quality of life; Other: Gynecological assessment

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hôpital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients who had Richter intervention

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Angeline Favre-Inhofer, Hôpital FOCH; Study Director: Jean-Marc Ayoubi, Hôpital FOCH

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 2018_0072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No