The Association of Total Hysterectomy and Disorders of Female Pelvic Floor or Sexual Function: a Survey on Pelvic Floor Function and Sexual Life for Women After Different Type of Hysterectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Quality of life change
研究概览
简要总结
In this prospective, comparative non-randomized multiple teaching hospitals study, the investigators try to determine the relationship of total hysterectomy and Taiwanese female pelvic floor and sexual function from the view of epidemiology and clinical survey. This is an important issue that related to female autonomy, health care resources and even national health policy. The study results will help to understand whether there is unnecessary part in the current hysterectomy procedures and its potential health hazard.
详细描述
Women with benign gynecology disease and indicated for laparoscopic hysterectomy (laparoscopic subtotal hysterectomy: LSH, laparoscopic cervical ligament sparing hysterectomy: CLSH, laparoscopic assisted vaginal hysterectomy: LAVH) are invited and explained the details of the protocol by the surgeon. The types of hysterectomy are determined by the patient and the surgeon together after discussion. All participant have to sign the informed consent. The participant will be followed up for two years after surgery. Preoperative evaluation on uterine condition, pelvic floor, questionaires were recorded. The perioperative parameters including surgical time, blood loss, and postoperative parameters such as pain score, hospitalization etc were recorded. The postoperative evaluation on pelvic floor condition, questionaires etc were also recorded at different time points.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient who is indicated for hysterectomy due to benign gynecology disease. The participant's husband is also welcomed to join the survey of the sexual life questionnaire but this is not a necessary inclusion criteria.
排除标准
- •Suspect of or diagnosed as cancer patient
- •Age < 30 or > 50 years old
- •Menopausal woman or woman who is nulliparous
- •Patient with advanced pelvic floor prolapse (stage 2, 3, 4) including uterine prolapse, cystocele, enterocele, rectocele.
- •Patient with prominent urinary incontinence that affect social activity or suggested to have surgery by gynecologist or urologist.
- •Patient with severe medical diseases such as liver cirrhosis, heart failure, poor control diabetes mellitus etc.
- •Patient with severe pelvic inflammatory disease/tubo-ovarian abcess or pelvic endometriosis or history of severe pelvic adhesions.
- •Psychiatric patients
- •Patient with chronic lung disease such as bronchial asthma, bronchiectasis, chronic obstructive pulmonary disease and interstitial lung disease
结局指标
主要结局
Quality of life change
时间窗: up to 12 months after hysterectomy
Evaluate the change of quality of life by questionaire --WHOQOL-BREF Taiwan version, at preoperation,1,3,6 and 12 months after hysterectomy.
次要结局
- Urinary incontinence status change(preoperation and 3,6 and 12 months after hysterectomy)
- Pelvic organ prolapse change(up to 24 months after hysterectomy)
- Sexual life change(preoperation and 3,6 and 12 months after hysterectomy)
- Urinary disorders change(preoperation and 3,6 and 12 months after hysterectomy)