NCT03901586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

May 16, 2019

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

April 2, 2019

Last Update Submit

May 15, 2019

Conditions

Genital Prolapse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Long term anatomic impact of the procedure

    7 months

  • Post-operative complications

    7 months

Study Arms (1)

Patients who had Richter intervention

EXPERIMENTAL
Other: Satisfaction assessmentOther: Quality of lifeOther: Gynecological assessment

Interventions

Satisfaction assessmentOTHER

Patient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect

Patients who had Richter intervention
Quality of lifeOTHER

The Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20)

Patients who had Richter intervention
Gynecological assessmentOTHER

An optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure

Patients who had Richter intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, 92151, France

Location

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Angeline Favre-Inhofer

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

  • Jean-Marc Ayoubi

    Hôpital Foch

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 3, 2019

Study Start

December 1, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 16, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)