NCT03943485

Utilization of Uterine Manipulator in Abdominal Hysterectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sexual Function Disturbances

Interventions

Type	Name	Description
DEVICE	The uterine manipulator which is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We adopted this device in abdominal hysterectomy.	The uterine manipulator is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We hypothesized that adoption of a uterine manipulator would help the surgeon to better identify the colpotomy site by moving the uterus cranially and thus providing better visualization of the colpotomy site.

Timeline

• Start date: 2017-05-05
• Primary completion: 2019-05-15
• Completion: 2019-05-20
• First posted: 2019-05-09
• Last updated: 2019-06-04

Locations

1 site across 1 country: Turkey (Türkiye)