Abdominal HysterectomyNCT05420662
The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations
A study testing Manipulation of vagina during abdominal hysterectomy operation and Classical conventional abdominal hysterectomy operation in people with Abdominal Hysterectomy, run by Kocaeli University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Abdominal Hysterectomy
- What is being tested?
- Manipulation of vagina during abdominal hysterectomy operation and Classical conventional abdominal hysterectomy operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2022to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who underwent hysterectomy due to abnormal uterine bleeding
- Myoma uteri, little than 5 cm which does not disrupt the uterine anatomy
Who cannot join
- Myoma uteri, which disrupts the uterine anatomy
- Intra-abdominal adhesions
- Endometrial intraepithelial neoplasia
- Endometrial cancer
- Ovarian cancer
- Cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes in Abdominal Hysterectomy Operations
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.
Read the 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.
- Conditions
- Abdominal Hysterectomy
- Being tested
- Manipulation of vagina during abdominal hysterectomy operation, Classical conventional abdominal hysterectomy operation
- Keywords
- Vaginal Manipulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation of vagina during abdominal hysterectomy operationProcedure or surgery
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 operationProcedure or surgery
Classical conventional abdominal hysterectomy operation without any manipulation from the vagina.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Classical conventional abdominal hysterectomy operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Length Difference
The difference between preoperative and postoperative vaginal length will be calculated
Measured: Preoperative one hour and postoperative one hour
Secondary outcomes (1)
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.
Measured: One to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start14 Jul 2022
- Primary completion26 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şener Gezer, Kocaeli University
- Investigators
- Şener Gezer, MD, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420662
- Sponsor's protocol ID
- KAEK /05.bI.05
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2022
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32238020
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vaginal Manipulator Use on the Residual Vaginal Length and Operative Outcomes in Abdominal Hysterectomy Operations
- ClinicalTrials.gov ID
- NCT05420662
- Acronym / sponsor ID
- KAEK /05.bI.05
- Conditions
- Abdominal Hysterectomy
- Keywords
- Vaginal Manipulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Manipulator Group | Experimental | Procedure: Manipulation of vagina during abdominal hysterectomy operationIn 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. |
| Classical Abdominal Hysterectomy Group | Active comparator | Procedure: Classical conventional abdominal hysterectomy operationIn this group of patients, abdominal hysterectomy surgery will be performed in a conventional way, by cutting the cardinal and sacrouterine ligaments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who underwent hysterectomy due to abnormal uterine bleeding
- Myoma uteri, little than 5 cm which does not disrupt the uterine anatomy
Key exclusion criteria (6 listed)
- Myoma uteri, which disrupts the uterine anatomy
- Intra-abdominal adhesions
- Endometrial intraepithelial neoplasia
- Endometrial cancer
- Ovarian cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulation of vagina during abdominal hysterectomy operationThe manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point. | Procedure or surgery | Vaginal Manipulator Group |
| Classical conventional abdominal hysterectomy operationClassical conventional abdominal hysterectomy operation without any manipulation from the vagina. | Procedure or surgery | Classical Abdominal Hysterectomy Group |
Primary outcome
Vaginal Length Difference
Time frame: Preoperative one hour and postoperative one hour
The difference between preoperative and postoperative vaginal length will be calculated
1 secondary outcome
Operation time
Time frame: One to two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 32238020Kiyak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şener Gezer, MD principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation of vagina during abdominal hysterectomy operation and Classical conventional abdominal hysterectomy operation in people with Abdominal Hysterectomy, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Length Difference (time frame: Preoperative one hour and postoperative one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.