The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

December 27, 2023 updated by: Şener Gezer, Kocaeli University

The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41380
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: Classical conventional abdominal hysterectomy operation
Classical conventional abdominal hysterectomy operation without any manipulation from the vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Length Difference
Time Frame: Preoperative one hour and postoperative one hour
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
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.
One to two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Şener Gezer, MD, Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Actual)

December 26, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 12, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KAEK /05.bI.05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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