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The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05420662
Enrollment
132
Registered
2022-06-15
Start date
2022-07-14
Completion date
2023-12-27
Last updated
2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Hysterectomy

Keywords

Vaginal Manipulator

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.

Interventions

PROCEDUREManipulation 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.

PROCEDUREClassical conventional abdominal hysterectomy operation

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

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Vaginal Length DifferencePreoperative one hour and postoperative one hourThe difference between preoperative and postoperative vaginal length will be calculated

Secondary

MeasureTime frameDescription
Operation timeOne to two hoursSkin-to-skin operation time and the time frame from the beginning of the hysterectomy to the moment when the uterus leaves the vagina.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026