Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Occurrence of vaginal bleeding 12 months after the procedure.
研究概览
简要总结
The occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The effect of this particular technique has not been reported.
Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1&K2, Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.
Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient satisfaction 12 months after the procedure (10-point analogue scale).
Design: Prospective randomised trial. Methods; The study participants are randomised to laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone pattern followed by electrocoagulation of the upper cervical canal (n =70).
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
- 是
入选标准
- •All premenopausal women who are referred to the departement due to a benign condition requiring hysterectomy and who have given informed consent are eligible for study recruitment
排除标准
- •Women who are unable to communicate in written Norwegian or oral English language.
- •Woman with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative smear or wtih atypical hyperplasia og malignancy in preoperative endometrial biopsy
- •Women who after a thorough clinical evaluation are found to be more suited for vaginal, abdominal or total hysterectomy
- •Women with a coexisting condition requiring no remaining ovaries after the procedure
- •Postmenopausal women
- •Women using hormone therapy (HT)
结局指标
主要结局
Occurrence of vaginal bleeding 12 months after the procedure.
时间窗: 12 months after operation
次要结局
- Patient satisfaction 12 months after the procedure (10-point analogue scale).(12 months after operation)