The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

Abdominal Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420662
• Other study ID #: KAEK /05.bI.05
• Status: Completed
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: December 27, 2023

Study information

• Verified date: December 2023
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 27, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Hysterectomy

Intervention

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

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kiyak H, Karacan T, Ozyurek ES, Turkgeldi LS, Kadirogullari P, Seckin KD. Abdominal Hysterectomy with a Uterine Manipulator Minimizes Vaginal Shortening: A Randomized Controlled Trial. J Invest Surg. 2021 Oct;34(10):1052-1058. doi: 10.1080/08941939.2020.1744774. Epub 2020 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal Length Difference	The difference between preoperative and postoperative vaginal length will be calculated	Preoperative one hour and postoperative one hour
Secondary	Operation time	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