Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923217
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2021-05-21
Brief Title:
Quality of Life and Sexual Function in Vaginal Aplasia Patients After Davydov Procedure
Sponsor:
School of Medicine - Vietnam National University at Ho Chi Minh city
Organization:
School of Medicine - Vietnam National University at Ho Chi Minh city
Study Overview
Official Title:
Assessing Quality of Life and Sexual Function in Vaginal Aplasia Patients After Neovaginal Surgical Procedure by Davydov Method
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Mayer-Rokitansky-Kuster-HauserMRKH syndrome is described as absence or underdevelopment of vagina and uterus This condition is extremely rare congenital malformation that affects one in every 5000 female births Medical management of MRKH syndrome includes the creation of a neovagina using nonsurgical or surgical procedure In Vietnam since 2014 Davydov technique has been used to create neovagina for patients with MRKH syndrome at Tu Du hospital which is the biggest obstetric and gynecological hospital in south of Vietnam However the effectiveness of this surgical approach on patients life and sexual activity hasnt been assessed The objective of this study is to assess the quality of life the psychological impact and the sexual function of Vietnamese women with MRKH syndrome after Davydov surgical procedure
Detailed Description:
This study will be conducted at Tu Du Hospital Ho Chi Minh City Vietnam Female patients diagnosed with Mayer-Rokitansky-Kuster-Hauser MRKH syndrome were performed the Davydov procedure to create neovagina at the Anaesthesia and Intensive care department Tu Du hospital Based on the Department of Anaesthesia and Intensive care data a list of potentially eligible patients who underwent Davydov surgery at least six months was made Because of the impact of the Covid 19 pandemic the patients could not come to the hospital so the research team decided to interview the participants online According to this list patients will be contacted by telephone to set up an online appointment to assess the effectiveness of the Davydov procedure The informed consent will be sent by email or mail to the patients who accepted to participate in our research before the enrolment On appointment day the investigator will make group telecommunication by an application on cell phone or computer Efficacy of Davydov procedure according to the functional aspect the psychological doctors assess the impact of patients neovagina on life and sexual function through questionnaires involving World Health Organization Quality of life Scale WHOQoL-BREF Female Sexual Function Index FSFI and self-composed qualitative questionnaire The interview with a patient will be held individually and conducted by the psychological doctor The participants will be requested to record the conversation Because MRKH syndrome is a rare condition the investigators take all patients who are suitable to inclusion criteria and accept participating in our research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None