An interventional study of Uterine Manipulator and Conventional Abdominal Hysterectomy in Leiomyoma (Uterine Fibroids), Adenomyoma of Uterus and Uterine Bleeding, sponsored by Erkan Gol. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Erkan Gol · Not applicable, Interventional, and Treatment
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.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Erkan Gol is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total abdominal hysterectomy performed using a uterine manipulator.
Procedure: Uterine Manipulator
Conventional total abdominal hysterectomy performed without uterine manipulator.
Procedure: Conventional Abdominal Hysterectomy
Use of a uterine manipulator during total abdominal hysterectomy.
Total abdominal hysterectomy without uterine manipulator.
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)
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)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
Of 52 non-industry interventional studies with no phase under Leiomyoma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 11 months is below that.
Counting every sponsor, half of 57 studies reached it within 31 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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