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

Erkan Gol60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Leiomyoma (Uterine Fibroids)Adenomyoma of Uterus Uterine Bleeding

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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

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

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

Postoperative Complications Within 30 Days

Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system.

Time frame: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)