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The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

Sponsor
Kocaeli University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05420662
Collaborator
(none)
146
Enrollment
1
Location
2
Arms
11.6
Anticipated Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Manipulation of vagina during abdominal hysterectomy operation
  • Procedure: Classical conventional abdominal hysterectomy operation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes in Abdominal Hysterectomy Operations
Actual Study Start Date :
Jul 14, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Vaginal Length Difference [Preoperative one hour and postoperative one hour]

    The difference between preoperative and postoperative vaginal length will be calculated

Secondary Outcome Measures

  1. Operation time [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli University Kocaeli Turkey 41380

Sponsors and Collaborators

  • Kocaeli University

Investigators

  • Principal Investigator: Şener Gezer, MD, Kocaeli University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Şener Gezer, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier:
NCT05420662
Other Study ID Numbers:
  • KAEK /05.bI.05
First Posted:
Jun 15, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Şener Gezer, Assistant Professor, Kocaeli University
Vaginal Manipulator

Study Results

No Results Posted as of Jul 15, 2022