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OpenTrials
Completed

NCT Number: NCT05420662

The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

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.

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Key information

Conditions

Abdominal Hysterectomy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manipulation of vagina during abdominal hysterectomy operation

Procedure

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

Classical conventional abdominal hysterectomy operation

Procedure

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

Primary outcomes

  1. Vaginal Length Difference

    Time frame: Preoperative one hour and postoperative one hour

    The difference between preoperative and postoperative vaginal length will be calculated

Secondary outcomes

  1. Operation time

    Time frame: One to two hours

    Skin-to-skin operation time and the time frame from the beginning of the hysterectomy to the moment when the uterus leaves the vagina.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2022
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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