LSH vs. TLH, A Randomized Single Blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Return to normal activities
研究概览
简要总结
The purpose of this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution.
Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).
Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.
6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.
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
- Single (Participant)
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
- •Candidates for laparoscopic hysterectomy for benign indications
排除标准
- •Malignancy of the uterus, cervix or adnexa
- •pre-malignant changes of the uterus, cervix or adnexa
- •history of severe cervical dysplasia (CIN II or above)
结局指标
主要结局
Return to normal activities
时间窗: 3-6 weeks after surgery
次要结局
- Sexual function(6 months after surgery)
研究者
Jon I. Einarsson
Chief, Division of Minimally Invasive Gynecology
Brigham and Women's Hospital