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临床试验/NCT07268196
NCT07268196招募中不适用

Impact of Liver Transplantation on Sexual Life and Function

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Evaluation of sexual function by questionnaire method

研究概览

简要总结

Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after liver transplantation.

详细描述

Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after LT

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Married male Patients.
  • Decompensated Chronic Liver Disease awaiting elective liver transplantation.
  • Post Liver Transplant patients with stable graft function.

排除标准

  • Negative consent.
  • Patients with ongoing medical and surgical issues (biliary complications, graft complication etc.).
  • Acute on Chronic Liver Failure and Acute Liver Failure patients.

结局指标

主要结局

Evaluation of sexual function by questionnaire method

时间窗: pre transplant, 3,6,12 months

Arizona Sexual Experience Scale (ASEX) scores for sexual dysfunction, ASEX scores are 5 point questionnaire with scores given for each question from 1-6. Total scores More than or equal to 19 indicate sexual dysfunction (higher the scores greater the sexual dysfunction).

Evaluation of erectile dysfunction using questionnaire method

时间窗: pre transplant, 3,6,12 months

International Index for Erectile Function - 5 (IIEF-5) scores for erectile dysfunction IIEF 5 scores are also a 5 point questionnaire with score ranging 0-6 for each question. Total scores less than 15 indicate mild to moderate erectile dusfunction and scores less than 11 indicate moderate erectile dysfunction (lower the scores higher the erectile dysfunction)

次要结局

  • Correlation between testosterone and Meld Na scores(pre transplant, 3,6,12 months)
  • Sarcopenia implication in recovery of sexual function.(pre transplant, 3,6,12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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