The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

Last updated: December 27, 2023
Sponsor: Kocaeli University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Manipulation of vagina during abdominal hysterectomy operation

Classical conventional abdominal hysterectomy operation

Clinical Study ID

NCT05420662
KAEK /05.bI.05
  • Ages 18-80
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Myoma uteri, which disrupts the uterine anatomy
  • Intra-abdominal adhesions
  • Endometrial intraepithelial neoplasia
  • Endometrial cancer
  • Ovarian cancer
  • Cervical cancer

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: Manipulation of vagina during abdominal hysterectomy operation
Phase:
Study Start date:
July 14, 2022
Estimated Completion Date:
December 27, 2023

Study 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.

Connect with a study center

  • Kocaeli University

    Kocaeli, 41380
    Turkey

    Site Not Available

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