The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

Study Overview
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Brief Summary
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If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is significantly shortened.

Detailed Description
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In a classical abdominal hysterectomy, the Cardinal ligaments and the Sacrouterine ligaments are cut before the uterus leaves the vagina, and the vaginal cuff is cut deeper in the vagina over the cervix and separated from the vagina. During this procedure, the vaginal tissue in the Portio vaginalis comes out and causes a loss of vaginal length. If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is significantly shortened.

Official Title
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The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes in Abdominal Hysterectomy Operations

Conditions
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Abdominal Hysterectomy

Intervention / Treatment
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* Procedure: Manipulation of vagina during abdominal hysterectomy operation
* Procedure: Classical conventional abdominal hysterectomy operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who underwent hysterectomy due to abnormal uterine bleeding Myoma uteri, little than 5 cm which does not disrupt the uterine anatomy Exclusion Criteria: Myoma uteri, which disrupts the uterine anatomy Intra-abdominal adhesions Endometrial intraepithelial neoplasia Endometrial cancer Ovarian cancer Cervical cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Manipulator Group<br>In this group of patients, abdominal hysterectomy surgery will be performed with the vaginal manipulator. After cutting and suturing uterine arteries, cardinal and sacrouterine ligaments are preserved by using a vaginal manipulator. The manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point of the vagina. | Procedure: Manipulation of vagina during abdominal hysterectomy operation<br>* The manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point.<br>|
| Active Comparator: Classical Abdominal Hysterectomy Group<br>In this group of patients, abdominal hysterectomy surgery will be performed in a conventional way, by cutting the cardinal and sacrouterine ligaments. | Procedure: Classical conventional abdominal hysterectomy operation<br>* Classical conventional abdominal hysterectomy operation without any manipulation from the vagina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Length Difference | The difference between preoperative and postoperative vaginal length will be calculated | Preoperative one hour and postoperative one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Skin-to-skin operation time and the time frame from the beginning of the hysterectomy to the moment when the uterus leaves the vagina. | One to two hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal Manipulator