The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

Kocaeli University

Status: Completed

Conditions: Abdominal Hysterectomy

Treatments: Procedure: Classical conventional abdominal hysterectomy operation; Procedure: Manipulation of vagina during abdominal hysterectomy operation

Study type: Interventional

Funder types: Other

Identifiers

NCT05420662

KAEK /05.bI.05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups

Vaginal Manipulator Group

Experimental group

Description:

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.

Treatment:

Procedure: Manipulation of vagina during abdominal hysterectomy operation

Classical Abdominal Hysterectomy Group

Active Comparator group

Description:

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

Treatment:

Procedure: Classical conventional abdominal hysterectomy operation