Adenomyoma of Uterus, Leiomyoma (Uterine Fibroids), Uterine Bleeding
Conditions
Keywords
Hysterectomy, Uterin Manipulator, Female Sexual Function, FSFI, Randomized Controlled Trial
Brief summary
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
PROCEDUREUterine Manipulator
Use of a uterine manipulator during total abdominal hysterectomy.
PROCEDUREConventional Abdominal Hysterectomy
Total abdominal hysterectomy without uterine manipulator.
Sponsors
Erkan Gol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will be blinded to group allocation. Data analysis will be performed using coded group assignments.
Intervention model description
Participants will be randomized 1:1 into two parallel groups: abdominal hysterectomy with uterine manipulator versus abdominal hysterectomy without uterine manipulator.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-Month Postoperative Female Sexual Function Index Total Score | Assessed at postoperative month 3 (±2 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Measured intraoperatively from skin incision to skin closure (single assessment during surgery) | Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy. |
| Postoperative Pain Assessed by Visual Analog Scale (VAS) | Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery | Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. |
| Change in Hemoglobin Level | Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery | Difference between preoperative hemoglobin level and hemoglobin level measured 24 hours after surgery to assess perioperative blood loss. |
| Length of Hospital Stay | From the date of surgery until hospital discharge, assessed up to 30 days postoperatively | Duration of hospitalization measured in days from the date of surgery until discharge. |
| Postoperative Complications Within 30 Days | From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery) | Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system. |
Countries
Turkey (Türkiye)
Contacts
CONTACTErkan Göl, MD
PRINCIPAL_INVESTIGATORErkan Göl, MD
University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey
Outcome results
None listed