Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07431788

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

Led by Erkan Gol · Updated on 2026-03-03

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, single-center, randomized controlled trial to assess how using a uterine manipulator during total abdominal hysterectomy affects female sexual function three months after surgery. The study focuses on women undergoing hysterectomy for benign conditions such as uterine fibroids, adenomyoma, or uterine bleeding. The main goal is to measure postoperative sexual function using the Female Sexual Function Index (FSFI). Participants are randomly assigned to one of two groups: one group undergoes total abdominal hysterectomy with a uterine manipulator, and the other group undergoes the same surgery without the manipulator. Both procedures are performed under double masking to reduce bias. The trial also examines secondary outcomes including operative time, changes in hemoglobin levels, postoperative pain at several time points, length of hospital stay, and complications occurring within 30 days after surgery. During the study, participants will complete the FSFI questionnaire three months after surgery to assess sexual function. Researchers will monitor operative details during surgery and assess pain levels using a visual analog scale at 6, 12, and 24 hours postoperatively. Hemoglobin levels will be measured at similar time points. Hospital stay duration and any complications within 30 days after surgery will be recorded. The entire participation focuses on these assessments to evaluate the impact of the uterine manipulator on recovery and sexual health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 218 years or older
  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo total abdominal hysterectomy either with or without the use of a uterine manipulator, followed by immediate post-operative assessments.

1 surgery visit and assessments up to 24 hours after surgery

Post-operative Follow-up

Duration - Up to 30 days

Participants are monitored for postoperative pain, hemoglobin levels, complications, and length of hospital stay up to 30 days after surgery.

Assessments at 6, 12, and 24 hours after surgery plus hospital stay monitoring

Follow-up for Sexual Function Assessment

Duration - Approximately 3 months

Participants complete the Female Sexual Function Index questionnaire to assess postoperative sexual function approximately 3 months after surgery.

1 follow-up visit (in-person or remote) around postoperative month 3 (±2 weeks)

Trial Site Locations

Total: 1 location

1

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye), 34147

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Research Team

E

Erkan Göl, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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