跳至主要内容
临床试验/CTRI/2024/10/074680
CTRI/2024/10/074680尚未招募不适用

To study the psychosocial and sexual impact of Genito-urinary and Recto-vaginal Fistula in women in India

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
1. Psychosocial health assessed by SF-36 questionnaire

研究概览

简要总结

It is a  ambispective study to study the psychosocial and sexual impact of Genito-urinary and recto-vaginal fistula in women in India. Women with fistula experience constant leakage of urine and/or feces and it affects a woman’s physical, economic, psychological, sexual and social life. Quality of life of patients living with Genito-urinary fistula/ Rectovaginal fistula is deeply affected. Surgery is the mainstay of treatment. This study aims to assess the psycho-social and sexual impact of Genito-urinary and/or recto-vaginal fistulas in women.The primary objective of this study is to assess the impact on psychological health and social relationships and sexual health in women with Genito-Urinary fistula and recto-vaginal fistula. The secondary objective of this study is to assess physical health, to assess the risk factors associated with Genito-Urinary and recto-vaginal fistula, to assess intra-operative complications of various fistula surgeries and to assess short term and long-term complications of various fistula surgeries.

METHODOLOGY-If you decide to participate in this study, and you had surgery for Genito-urinary fistula/ rectovaginal fistula at AIIMS, New Delhi, your surgical records will be retrieved and intraoperative and immediate post operative complications will be noted down from your case sheet. Your current symptoms pertaining to fistula or urinary/ bowel complaints, sexual dysfunction, chronic pain, discharge etc. will be asked in details and pelvic examination will be done .You will be asked to fill the SF-36 and FSFI questionnaire. If you have Genito-urinary/ rectovaginal fistula and are about to undergo some surgical procedure for correction of the same, your detailed history will be taken and pelvic examination will be done. SF-36 and FSFI questionnaire will be filled pre-operatively. During surgery, any intraoperative complications will be noted. Similarly, immediate postoperative complications will be noted. You will be asked to visit once at  6 weeks and then at 6 months. In both the visits, you’ll be asked for your complaints and symptoms and physical examination will be done. SF-36 and FSFI questionnaire will be filled at 6 weeks and 6 months.

The primary outcomes are Psychosocial health assessed by SF-36 questionnaire and Sexual health assessed by FSFI -6 questionnaire. The secondary outcomes are Operating time, Intra-operative complications, Total hospital stay and Short-term and long-term complications

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed case of Genito-Urinary Fistula/ Recto-vaginal fistula
  • Willing to participate in the study.
  • Willing to follow-up.

排除标准

  • Not willing to participate in the study.
  • Known case of malignancy.
  • Radiation fistula.
  • Patients with co-morbidities affecting Quality of life.
  • Colo-vaginal fistula.

结局指标

主要结局

1. Psychosocial health assessed by SF-36 questionnaire

时间窗: 10 YEARS

2.Sexual health assessed by FSFI -6 questionnaire

时间窗: 10 YEARS

次要结局

  • 1. Operating time(2. Intra-operative complications)

研究者

发起方
AIIMS NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ashita Aggarwal

AIIMS, New Delhi

研究点 (1)

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