A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.
研究概览
简要总结
Objective: To compare the occurrence and intensity of pelvic pain as well as patient satisfaction and quality of life after total laparoscopic and laparoscopic supracervical hysterectomy.
Design: Prospective randomised trial.
Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic pain following TLH compared with following LSH.
Null hypothesis 2: There is no significant difference in patient satisfaction and quality of life following TLH compared with following LSH.
详细描述
Sample: 62 consecutive premenopausal women referred to the department for hysterectomy on the basis of a benign condition. The expected mean pain reduction (m) in the LSH group: 3.32, sd (s): 2.71.24 A difference in mean pain reduction (d) equal to 1 sd is considered a clinically important improvement (standardised difference d/s=1). Number of women required (power 90 % and a level of significance 0.05): 62 patients.
Methods: The study participants are randomised to total laparoscopic hysterectomy (n = 31), or laparoscopic supracervical hysterectomy (n = 31).
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women who are referred to the department
- •benign condition requiring hysterectomy
- •Dysmenorrohea/cyclic pelvic pain
- •Informed consent
排除标准
- •Women who are unable to communicate in Norwegian language.
- •Women with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative cervical smear.
- •Women with atypical hyperplasia or malignancy in preoperative endometrial biopsy.
- •Women with a substantially enlarged uterus requiring abdominal hysterectomy or not suitable for TLH (> 12 week amenorrhea).
- •Women with a concomitant condition requiring uni- or bilateral oophorectomy.
- •Postmenopausal women.
- •Women with no dysmenorrohea/cyclic pelvic pain (<1 on a 10-point visual analogue scale).
- •Women with deep infiltrating endometriosis.
结局指标
主要结局
Pelvic pain reduction after the procedure. Occurrence and intensity of pelvic pain after the procedure.
时间窗: 12 months after the procedure
10-point visual analogue scale. Values are given as median (range), mean (sd) or n (%).
次要结局
- Frequency of menopause(12 months after surgery)
- Frequency of adenomyosis in specimen from the operation.(postoperative)
- Patient satisfaction after the procedure(12 months after the procedure)
- Occurrence of vaginal bleeding after the procedure(12 months after the procedure)
- Improvement in patient Quality of Life after the procedure(12 months after the procedure)
- Frequency of perioperative and postoperative complications.(Perioperative and the periode 12 months after the prosedure)
- Frequency and grade of genital prolapse(60 and 120 months after procedure)
- Volume of uterine corpus preoperative, location and size of fibromas, Weight of the removed uterus/uterine corpus.(Pre- and perioperative)