Utilization of Uterine Manipulator in Abdominal Hysterectomy

NCT ID: NCT03943485

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2019-05-20

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.

Conditions

Sexual Function Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Uterien Manipulator Arm

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

Group Type: ACTIVE_COMPARATOR

The uterine manipulator which is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We adopted this device in abdominal hysterectomy.

Intervention Type: DEVICE

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huseyin Kiyak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huseyin Kiyak, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Hospital

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Huseyin1

Identifier Type: -

Identifier Source: org_study_id