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The Effect of Uterine Manipulator Use During Abdominal Hysterectomy on Postoperative Sexual Function

ConditionsLeiomyoma (Uterine Fibroids)Adenomyoma of UterusUterine Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorErkan Gol

About this trial

This prospective, single-center, randomized controlled trial aims to evaluate the effect of uterine manipulator use during total abdominal hysterectomy on postoperative female sexual function at 3 months, assessed by the Female Sexual Function Index (FSFI). Secondary outcomes include operative time, perioperative hemoglobin change, postoperative pain (VAS), hospital stay duration, and 30-day complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged ≥18 years

Planned total abdominal hysterectomy for benign indications

Sexually active within the last 4 weeks

Able to complete the Female Sexual Function Index (FSFI) questionnaire

Disqualifiers

Gynecologic malignancy

Major additional pelvic reconstructive surgery

Severe psychiatric or neurologic disorder

Inability to complete follow-up assessments

Trial design

Design model

Parallel

Treatments tested in this trial

  • Uterine Manipulator

    Procedure/Surgery

    Use of a uterine manipulator during total abdominal hysterectomy.

  • Conventional Abdominal Hysterectomy

    Procedure/Surgery

    Total abdominal hysterectomy without uterine manipulator.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Abdominal Hysterectomy With Uterine ManipulatorExperimental treatment 1 intervention
Group B: Abdominal Hysterectomy Without Uterine ManipulatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3-Month Postoperative Female Sexual Function Index Total Score

Female Sexual Function Index (FSFI) total score measured at 3 months after surgery. The FSFI is a validated 19-item questionnaire assessing sexual function across six domains. Total scores range from 2 to 36, with higher scores indicating better sexual function.

Time frame
Assessed at postoperative month 3 (±2 weeks)

Secondary outcomes

1

Operative Time

Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy.

Time frame
Measured intraoperatively from skin incision to skin closure (single assessment during surgery)
2

Postoperative Pain Assessed by Visual Analog Scale (VAS)

Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

Time frame
Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
3

Change in Hemoglobin Level

Difference between preoperative hemoglobin level and hemoglobin level measured 24 hours after surgery to assess perioperative blood loss.

Time frame
Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
4

Length of Hospital Stay

Duration of hospitalization measured in days from the date of surgery until discharge.

Time frame
From the date of surgery until hospital discharge, assessed up to 30 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erkan Gol

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Sponsor institution

Source ClinicalTrials.gov
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