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Completed

NCT Number: NCT03901586

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

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.

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Key information

Conditions

Genital Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Foch

Suresnes, 92151, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Satisfaction assessment

Other

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

Quality of life

Other

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

Gynecological assessment

Other

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

Primary outcomes

  1. Long-term satisfaction of the Richter procedure

    Time frame: 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 outcomes

  1. Long term anatomic impact of the procedure

    Time frame: 7 months

    An optional gynecological consult is proposed to the patients

  2. Post-operative complications

    Time frame: 7 months

    Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: RICHTER

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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