Utilization of Uterine Manipulator in Abdominal Hysterectomy

Not Applicable

Completed

• Conditions: Sexual Function Disturbances
• Interventions: Device: The uterine manipulator which is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We adopted this device in abdominal hysterectomy.

• Registration Number: NCT03943485
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Study Timeline

• Study Start: 2017-05-05
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

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

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Exclusion Criteria

• Apical prolapsus Endometriosis Psychiatric disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterien Manipulator Arm	The uterine manipulator which is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We adopted this device in abdominal hysterectomy.	Patients in this group will receive a uterine manipulator during abdominal hysterectomy.

Primary Outcome Measures

Name	Time	Method
Female sexual function index (FSFI)	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	Pre- to the postoperative 3 months	The change in vaginal length

Secondary Outcome Measures

Name	Time	Method
Surgeons' satisfaction: Surgeons' satisfation score	Just after the surgery	Surgeons' satisfation score. Surgeon satisfaction (SS) and resident satisfaction (RS) for determining the adequate colpotomy site will be evaluated at the end of the procedure surgeon's satisfaction score (SSS) which was scored by the surgical team performing the surgery on a five-point Likert scale as follows: 1 = Very difficult/very poor and 5 = Easy/Good (10). The difference in SS and RS between the two groups will also be a secondary outcome of the present study.

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Please Enter The State Or Province, Turkey