Utilization of Uterine Manipulator in Abdominal Hysterectomy

NCT03943485 | Completed

• 1 other identifier: Huseyin1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Function Disturbances

Keywords

abdominal hysterectomy; uterine manipulator; vaginal length; sexual function; surgeons' satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Surgeons' satisfaction: Surgeons' satisfation score

  Just after the surgery

Study Arms (2)

Uterien Manipulator Arm

ACTIVE COMPARATOR

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.

Control

NO INTERVENTION

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

Interventions

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

Uterien Manipulator Arm

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Apical prolapsus Endometriosis Psychiatric disease

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Huseyin Kiyak, MD

  Kanuni Sultan Suleyman Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: May 5, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 20, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)