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临床试验/NCT04923217
NCT04923217已完成不适用

Assessing Quality of Life and Sexual Function in Vaginal Aplasia Patients After Neovaginal Surgical Procedure by Davydov Method

School of Medicine - Vietnam National University at Ho Chi Minh city1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
1
主要终点
Sexual Function of women with vaginal agenesis after Davydov procedure

研究概览

简要总结

Mayer-Rokitansky-Kuster-Hauser(MRKH) 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 patient's life and sexual activity hasn't 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.

详细描述

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 patient's 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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged equal or more than
  • Diagnosed vaginal agenesis and underwent Davydov procedure to create neovagina at least 6 months.
  • Able to listen, understand and answer questions.

排除标准

  • Disagreed to participate the research.
  • Having any conditions that make patient unable to listen, understand and answer questions.
  • Having psychological disturbance.

结局指标

主要结局

Sexual Function of women with vaginal agenesis after Davydov procedure

时间窗: From six months after surgery up to the initiation of the study, assessed up to 1 month

The psychological doctor uses the questionnaire named Female Sexual Function Index Scale (FSFI) in the interview to ask patient. The patient's sexual function will be assessed based on the FSFI questionnaire 's score. All the results will be collected and calculated subsequently. The FSFI's minimum total score is 2 and the FSFI's maximum total score is 36. The patient is diagnosed to have sexual dysfunction when the FSFI's total score is less than 26,55.

Quality of Life of women with vaginal agenesis after Davydov procedure

时间窗: From six months after surgery up to the initiation of the study, assessed up to 1 month

The psychological doctor uses the questionnaire named World Health Organization Quality of Life Scale(WHOQoL-BREF) in the interview to ask patient. The patient's Quality of Life will be assessed based on the WHOQoL-BREF questionnaire 's score. All the results will be collected and calculated subsequently. The raw scores are converted to transformation scores. The first transformation converts scores to range of 4-20 and the second transformation converts domain scores to 0-100 scale. Higher scores reflect better Quality of Life.

次要结局

未报告次要终点

研究者

发起方
School of Medicine - Vietnam National University at Ho Chi Minh city
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thanh Le Trung Quoc

Principle investigator

School of Medicine - Vietnam National University at Ho Chi Minh city

研究点 (1)

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