The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations

NCT05420662 | Completed

• 1 other identifier: KAEK /05.bI.05
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Hysterectomy

Keywords

Vaginal Manipulator

Outcome Measures

Primary Outcomes (1)

• Vaginal Length Difference

  The difference between preoperative and postoperative vaginal length will be calculated

  Preoperative one hour and postoperative one hour

Secondary Outcomes (1)

• Operation time

  One to two hours

Study Arms (2)

Vaginal Manipulator Group

EXPERIMENTAL

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

Classical Abdominal Hysterectomy Group

ACTIVE COMPARATOR

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

Interventions

Manipulation of vagina during abdominal hysterectomy operation PROCEDURE

The manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point.

Vaginal Manipulator Group

Classical conventional abdominal hysterectomy operation PROCEDURE

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

Classical Abdominal Hysterectomy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who underwent hysterectomy due to abnormal uterine bleeding
• Myoma uteri, little than 5 cm which does not disrupt the uterine anatomy

You may not qualify if:

• Myoma uteri, which disrupts the uterine anatomy
• Intra-abdominal adhesions
• Endometrial intraepithelial neoplasia
• Endometrial cancer
• Ovarian cancer
• Cervical cancer

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related 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.

  PMID: 32238020 BACKGROUND

Study Officials

• Şener Gezer, MD

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 15, 2022
• Study Start: July 14, 2022
• Primary Completion: December 26, 2023
• Study Completion: December 27, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)