Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Quality of life and patient's impression of improvement at 36 months after surgery
研究概览
简要总结
The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).
Participants will fill the following questionnaires pre-operatively and at the follow up:
- Short Form 36 (SF36),
- Euro Quality of life 5D-3L (EQ 5D-3L)
- Female Sexual Function Index (FSFI)
- Patient Global Impression of Improvement (PGI-I) only during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Signed informed consent
排除标准
- •Uterine or adnexal pathology suspect for malignancy
- •Abnormal or unknown PAP test
- •Patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer T1 N0 M0 Grade 1 or 2 without signs of recurrence or activity).
- •Previous radical pelvic surgery or radiotherapy;
- •Age > 80 years
- •Pregnant patients
- •Desire for further pregnancies
- •Contraindications to general anaesthesia or to the Trendelenburg position
- •Refusal to sign informed consent
研究组 & 干预措施
patients undergoing total hysterectomy
Total hysterectomy involves the complete removal of the uterus including the cervix
干预措施: total hysterectomy (Procedure)
patients undergoing subtotal hysterectomy
Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix
干预措施: subtotal hysterectomy (Procedure)
结局指标
主要结局
Quality of life and patient's impression of improvement at 36 months after surgery
时间窗: 5 years
To assess the impact of surgery on patients' quality of life measured by the Physical Functioning items of SF36 questionnaire, at 36 months after surgery
次要结局
- Postoperative pain(5 years)
- Intra-operative data(5 years)
- intraoperative complications(5 years)
- short and long-term postoperative complications(5 years)
- Urinary, bowel and pelvic floor symptoms(5 years)