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Recruiting NCT07431788

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

No phase Interventional Leiomyoma (Uterine Fibroids) Adenomyoma of Uterus Uterine Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Uterine Manipulator, Conventional Abdominal Hysterectomy.
Who it may be relevant to
Registry conditions: Leiomyoma (Uterine Fibroids), Adenomyoma of Uterus, Uterine Bleeding. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function

Overview

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.

Interventions

  • Procedure Uterine Manipulator
    Use of a uterine manipulator during total abdominal hysterectomy.
  • Procedure Conventional Abdominal Hysterectomy
    Total abdominal hysterectomy without uterine manipulator.

Primary outcome measures

  • 3-Month Postoperative Female Sexual Function Index Total Score [Time frame: Assessed at postoperative month 3 (±2 weeks)]
Secondary outcome measures (5)
  • Operative Time [Time frame: Measured intraoperatively from skin incision to skin closure (single assessment during surgery)]
  • Postoperative Pain Assessed by Visual Analog Scale (VAS) [Time frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery]
  • Change in Hemoglobin Level [Time frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery]
  • Length of Hospital Stay [Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively]
  • Postoperative Complications Within 30 Days [Time frame: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)]

Eligibility criteria

Inclusion criteria

  • 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
  • Provided written informed consent

Exclusion criteria

  • Gynecologic malignancy
  • Major additional pelvic reconstructive surgery
  • Severe psychiatric or neurologic disorder
  • Inability to complete follow-up assessments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07431788 · 2026-04-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗