The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

Not Applicable

Completed

• Conditions: Abdominal Hysterectomy
• Interventions: Procedure: Classical conventional abdominal hysterectomy operation; Procedure: Manipulation of vagina during abdominal hysterectomy operation

• Registration Number: NCT05420662
• Lead Sponsor: Kocaeli University

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.

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 Timeline

• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-12
• Study First Posted: 2022-06-15
• Study Start: 2022-07-14
• Status Verified: 2023-12
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-27
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classical Abdominal Hysterectomy Group	Classical conventional abdominal hysterectomy operation	In this group of patients, abdominal hysterectomy surgery will be performed in a conventional way, by cutting the cardinal and sacrouterine ligaments.
Vaginal Manipulator Group	Manipulation of vagina during abdominal hysterectomy operation	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.

Primary Outcome Measures

Name	Time	Method
Vaginal Length Difference	Preoperative one hour and postoperative one hour	The difference between preoperative and postoperative vaginal length will be calculated

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey