Randomized Clinical Trial of Total Versus Subtotal Abdominal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 319
- 试验地点
- 2
- 主要终点
- change in Urinary incontinence from baseline (preoperatively)
研究概览
简要总结
319 Women undergoing hysterectomy for benign (not cancer) indications were randomly allocated to 2 types of surgery (Total (TAH) and Subtotal (SAH)) abdominal hysterectomy 15 years ago. They were followed by questionnaire at time of surgery and up to 5 years (not yet published) after the surgery and evaluated regarding following outcomes: Urinary incontinence, pain, bowel problems, per and postoperative complications, sexuality, quality of life, pelvic organ prolapse and vaginal bleeding. Now the investigators are conducting a 15 year follow up with the same out-come measures but also including physical examinations regarding Urinary incontinence, voiding difficulties, pelvic organ prolapse and problems with the cervix. The investigators' hypothesis is that several of the out-come measures will be present in more cases than earlier due to age and menopausal changes. The investigators expect more urinary incontinence in the subtotal group as this was seen at earlier follow ups. The investigators expect to find more women with pelvic organ prolapse with the physical examination than by questionnaire alone, possibly with a higher incidence in the subtotal group.
详细描述
The study included women who were offered a hysterectomy for benign uterine disease such as: metrorrhagia, menorrhagia, fibroids, endometriosis,and pelvic pain. Women in need of hysterectomy for malignant disease or because of prolapse of the uterus were not included. They were followed up by a questionnaire covering all outcome measures as described above. Background information was registered in a second questionnaire prior to surgery. All gynaecological departments in Denmark were invited to join the trial. 11 departments contributed randomized patients to the trial.
the results up to 1 year after surgery have been published, links can be found in the citation list. The results from the 5 year follow up have not yet been published.
The questionnaire used in this trial consists of the validated SF-36 (Short Form 36) quality of life questionnaire as well as a thorough questionnaire regarding the outcome measures described elsewhere. The entire questionnaire was validated prior to the beginning of the trial.
A second questionnaire has been added in the 15 year follow up: PFDI-20(Pelvic Floor Distress Inventory 20). The investigators included this, as it is more thorough regarding pelvic organ prolapse and in particular a "bother" measure than the original questionnaire.
The 20 min. pad-weighing test has been tested against the 1 hour gold-standard used by the ICS (International Continence Society) and has been found to give comparable results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Women undergoing abdominal hysterectomy for benign uterine disease at a gynaecological department in Denmark (15 years ago)
排除标准
- •malignant disease
- •mental disease
- •neurological disease
- •not able to read and write Danish
- •pelvic organ prolapse as the reason for hysterectomy
- •prior surgery for urinary incontinence
结局指标
主要结局
change in Urinary incontinence from baseline (preoperatively)
时间窗: 2 months, 6months, 1, 5 and 15 years postoperatively
urinary incontinence measured by questionnaire filled out by the participants at each time point as well as a more objective measure: pad weighing test and voiding diary at 15 years
次要结局
- pelvic organ prolapse(preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively)
- cervical problems in the SAH group(preoperatively, 2 months, 6months, 1, 5 and 15 years postoperatively)
- voiding difficulties and LUTS (Lower Urinary Tract Symptoms)(preoperatively, 2 months, 6 months, 1, 5 and 15 years postoperatively)
研究者
Lea Laird Andersen
MD, PhD.-student
Nykøbing Falster County Hospital