Utilization of Uterine Manipulator in Abdominal Hysterectomy

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Please Enter The State Or Province
    • Istanbul, Please Enter The State Or Province, Turkey, 34005
      • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Apical prolapsus Endometriosis Psychiatric disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Uterien Manipulator Arm; Patients in this group will receive a uterine manipulator during abdominal hysterectomy.	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.
NO_INTERVENTION: Control; Patients in this group will receive standard abdominal hysterectomy without adoption of a uterine manipulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal length	The change in vaginal length	Pre- to the postoperative 3 months
Female sexual function index (FSFI)	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.	Pre- to the postoperative 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeons' satisfaction: Surgeons' satisfation score	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.	Just after the surgery

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2017
• Primary Completion (ACTUAL): May 15, 2019
• Study Completion (ACTUAL): May 20, 2019

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 1, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: abdominal hysterectomy; sexual function; uterine manipulator; vaginal length; surgeons' satisfaction
• Other Study ID Numbers: Huseyin1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No