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The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

NCT ID: NCT05420662

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2023-12-27

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.

Conditions

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Abdominal Hysterectomy

Keywords

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Vaginal Manipulator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Vaginal Manipulator Group

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.

Group Type EXPERIMENTAL

Manipulation of vagina during abdominal hysterectomy operation

Intervention Type PROCEDURE

The manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point.

Classical Abdominal Hysterectomy Group

In this group of patients, abdominal hysterectomy surgery will be performed in a conventional way, by cutting the cardinal and sacrouterine ligaments.

Group Type ACTIVE_COMPARATOR

Classical conventional abdominal hysterectomy operation

Intervention Type PROCEDURE

Classical conventional abdominal hysterectomy operation without any manipulation from the vagina.

Interventions

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Manipulation of vagina during abdominal hysterectomy operation

The manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point.

Intervention Type PROCEDURE

Classical conventional abdominal hysterectomy operation

Classical conventional abdominal hysterectomy operation without any manipulation from the vagina.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Şener Gezer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Şener Gezer, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kiyak H, Karacan T, Ozyurek ES, Turkgeldi LS, Kadirogullari P, Seckin KD. Abdominal Hysterectomy with a Uterine Manipulator Minimizes Vaginal Shortening: A Randomized Controlled Trial. J Invest Surg. 2021 Oct;34(10):1052-1058. doi: 10.1080/08941939.2020.1744774. Epub 2020 Apr 2.

Reference Type BACKGROUND
PMID: 32238020 (View on PubMed)

Other Identifiers

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KAEK /05.bI.05

Identifier Type: -

Identifier Source: org_study_id