跳至主要内容
临床试验/NCT05728281
NCT05728281招募中不适用

Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2023年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
142
试验地点
1
主要终点
The Female Sexual Function Index score

研究概览

简要总结

In France, more than 62 000 hysterectomies are performed each year. Female sexual function is the result of multiple psychological, social and physiological factors. There is no information in the current literature about the optimum time between the surgery and the sexual relation resumption. The primary outcome is to assess the impact of advising time between hysterectomy and sexual relation resumption by using FSFI® score. Secondaries outcomes are: to describe and compare post-operative complications in the two groups of the study, to describe the follow-up of the recommendation concerning time between surgery and sexual relation resumption and to describe why this recommendation was not followed. This study is based on 4 questionnaires: FSFI® pre-operative and post-operative, pre-operative questionnaire and post-operative questionnaire. This is a monocentric, comparative, of superiority, randomised and prospective study. Patients are randomised into two groups: sexual relation resumption advised 4 weeks after surgery, or 8 weeks. The inclusion criteria are more than 18 years, francophone, in sexual activity, scheduled for a total hysterectomy for benign indication (menometrorrhagia, fibroma, adenomyosis, endometriosis, pelvic floor disorders, low-grade endometrial cancer), considering vaginal, laparoscopic and abdominal approach, and a written consent. Non-inclusion criteria are illiteracy, cognitive disorders, without social security, deprived liberty by judicial or administrative decision, psychiatric care, patient with legal protection, patient incapable of giving consent. If our conclusions confirmed our hypothesis, it can improve clinical practices by providing additional informations for surgeon and patient, to undergo this surgery as serenely as possible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Patient ≥ 18 years old,
  • •Francophone,
  • •Sexually active,
  • •Receiving a conservative or non-conservative total hysterectomy for benign pathology*,
  • •Having signed a consent form. All surgical approaches are considered, laparoscopic approach with laparoscopic or vaginal closure, vaginal approach and laparotomy.
  • •*The indications for the procedure selected for this study include:
  • •Menometrorrhagia,
  • •Fibroids,
  • •Adenomyosis,
  • •Endometriosis,
  • •Pelvic statics disorder,
  • •Cervical dysplasia,
  • •Endometrial cancer not requiring lymph node dissection or additional treatment.

排除标准

  • 未提供

研究组 & 干预措施

Resumption of sexual intercourse recommended 4 weeks after hysterectomy

Other

干预措施: Recommended time after hysterectomy (Other)

Resumption of sexual intercourse recommended 8 weeks after hysterectomy

Other

干预措施: Recommended time after hysterectomy (Other)

结局指标

主要结局

The Female Sexual Function Index score

时间窗: one year

Assessment of the impact of the recommended time between hysterectomy and resumption of sexual intercourse on sexual function using the Female Sexual Function Index score

次要结局

  • Follow-up to the recommendation(one year)
  • Postoperative complications(one year)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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