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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Hysterectomy With Uterine Manipulator | Experimental | Total abdominal hysterectomy performed using a uterine manipulator. |
|
| Abdominal Hysterectomy Without Uterine Manipulator | Active Comparator | Conventional total abdominal hysterectomy performed without uterine manipulator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine Manipulator | Procedure | Use of a uterine manipulator during total abdominal hysterectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at postoperative month 3 (±2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy. | Measured intraoperatively from skin incision to skin closure (single assessment during surgery) |
| Postoperative Pain Assessed by Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erkan Göl, MD | Contact | +905398517917 | drerkangol@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Erkan Göl, MD | University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakirkoy Dr. Sadi Konuk Training and Research Hospital | Recruiting | Istanbul | Istanbul | 34147 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Participants will be randomized 1:1 into two parallel groups: abdominal hysterectomy with uterine manipulator versus abdominal hysterectomy without uterine manipulator.
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Patients will be blinded to group allocation. Data analysis will be performed using coded group assignments.
| Conventional Abdominal Hysterectomy | Procedure | Total abdominal hysterectomy without uterine manipulator. |
|
Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. |
| 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. | 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. | 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. | From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery) |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |