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临床试验/NCT03943485
NCT03943485已完成不适用

Does Implementation of a Uterine Manipulator Prevent Vaginal Length and Sexual Funcation After Abdominal Hysterectomy

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Female sexual function index (FSFI)

研究概览

简要总结

The investigators aimed to investigate whether the uterine manipulator which is usually utilized in laparoscopic hysterectomy would also be of benefit in preventing postoperative vaginal length and sexual function by facilitating the accurate localization fo the colpotomy site. Patients scheduled for abdominal hysterectomy for benign causes will be randomized into two arms: Group 1 Uterine manipulator arm in which participants received a uterine manipulator during the procedure for aiding to locate the accurate colpotomy site and Group 2 consisting of control patients who will not receive uterine manipulator but undergo a standard abdominal hysterectomy. Postoperative vaginal length, postoperative female sexual function index (FSFI) will be compared with the preoperative measurements in the two groups. A 5 points Surgeon satisfaction scale will also be applied to the surgeons and residents performing the surgery to address their satisfaction in locating the colpotomy site.

详细描述

The uterine manipulator is a device that facilitates to locate the colpotomy site and visualization of surgical are during laparoscopic hysterectomy. The investigators consider that adoption of the uterine manipulator will also facilitate to locate the colpotomy site in abdominal hysterectomy. Therefore the investigators are planning to enroll patients undergoing an abdominal hysterectomy in this study. Patients will be allocated into one of the study groups: Group 1 Uterine manipulator arm in which participants received a uterine manipulator during the procedure for aiding to locate the accurate colpotomy site and Group 2 consisting of control patients who will not receive uterine manipulator but undergo a standard abdominal hysterectomy. All abdominal hysterectomies will be carried out by the same surgeon under general anesthesia. One week before the surgery vaginal length will be measured and the female sexual function index (FSFI) will be obtained from all patients. Following the surgery vaginal length will again be measured at 3 months and the female sexual function index (FSFI) will be obtained from participants by a research staff who is also a gynecologist. Prevalence of postoperative dyspareunia will be asked to the patients at postoperative 3 months. Just after the surgery, a 5 points surgeons' satisfaction scale will also be completed by the surgeons and residents performing the surgery to address their satisfaction in locating the colpotomy site either with the uterine manipulator as in group 1 or by manually guiding as in group 2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Must be scheduled for total abdominal hysterectomy for benign causes Must be premenopausal Must be sexually active

排除标准

  • Apical prolapsus Endometriosis Psychiatric disease

研究组 & 干预措施

Uterien Manipulator Arm

Active Comparator

Patients in this group will receive a uterine manipulator during abdominal hysterectomy.

干预措施: The uterine manipulator which is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We adopted this device in abdominal hysterectomy. (Device)

Control

No Intervention

Patients in this group will receive standard abdominal hysterectomy without adoption of a uterine manipulator.

结局指标

主要结局

Female sexual function index (FSFI)

时间窗: Pre- to the postoperative 3 months

The change in Female sexual function index score. The Female Sexual Function Index (FSFI) is a brief multidimensional scale for assessing sexual function in women. !9 questions concerning the sexual function are asked. The minimum total score is 4 points. A maximum total score of 36 indicates excellent sexual function. Lower score indicate detoriorated sexual function.

Vaginal length

时间窗: Pre- to the postoperative 3 months

The change in vaginal length

次要结局

  • Surgeons' satisfaction: Surgeons' satisfation score(Just after the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huseyin Kiyak

Principal Investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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