HysterectomyNCT06776718
VNOTES and Vaginal Hysterectomy for Benign Indications
A study testing vNOTES and vaginal hysterectomy in people with Hysterectomy and Hysterectomy, Benign Uterine Diseases, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions. A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Hysterectomy, Hysterectomy, Benign Uterine Diseases, Hysterectomy, Vaginal
- What is being tested?
- vNOTES and vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2025to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 40 and 80 years
- undergo hysterectomy for benign gynecological conditions
Who cannot join
- history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
- suspected gynecologic malignancies,
- endometriosis,
- tubal-ovarian abscesses,
- pelvic organ prolapse exceeding grade 2,
- individuals who refused to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kartal Dr Lütfi Kirdar City Hospital
Istanbul, 34865
Kartal Dr. Lütfi Kırdar Şehir Hastanesi, +902164413900, istkartal.sh@saglik.gov.tr
Gazi Yıldız, Assoc Prof
About this study
Official title: Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications
This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.
A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.
- Being tested
- vNOTES, vaginal hysterectomy
- Keywords
- vNOTES, vaginal hysterectomy, benign gynecology, surgical outcomes, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTESProcedure or surgery
vNOTES for benign hysterectomy
vaginal hysterectomyProcedure or surgery
vaginal hysterectomy for benign hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| vNOTES hysterectomy for benign indications | Experimental | Not described Receives: Procedure: vNOTES |
| Vaginal hysterectomy for benign indications | Experimental | Not described Receives: Procedure: vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of surgery
İnterval from initial incision to the completion of vaginal cuff closure (minute)
Measured: The time from the beginning to the end of the operation
Secondary outcomes (4)
Hospitalization time
Time from surgery to discharge (hours)
Measured: through study completion, an average of 1 month
VAS score
Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)
Measured: postoperative 6th and 24 th hour
Uterin volume
Uterine volume is quantified in milimeters based on measurement of pathological specimens, calculate using the formula (Uterine volume (ml)= (anterior-posterior diameter)* (sagital diameter) * (transverse diameter) * 0,0005236
Measured: through study completion, an average of 1 month
Re-admission
Re-admission to hospital after discharge (yes/no)
Measured: within 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Mete Kırlangıç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776718
- Sponsor's protocol ID
- 2021/514/214/25
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yildiz P, Keles E, Yildiz G, Birol Ilter P, Temocin RB, Kaya C, Mat E. Health-related quality of life following hysterectomy by vNOTES versus conventional laparoscopy. Minim Invasive Ther Allied Technol. 2024 Aug;33(4):232-236. doi: 10.1080/13645706.2024.2323100. Epub 2024 Mar 4.
PubMed 39084252Merlier M, Collinet P, Pierache A, Vandendriessche D, Delporte V, Rubod C, Cosson M, Giraudet G. Is V-NOTES Hysterectomy as Safe and Feasible as Outpatient Surgery Compared with Vaginal Hysterectomy? J Minim Invasive Gynecol. 2022 May;29(5):665-672. doi: 10.1016/j.jmig.2022.01.007. Epub 2022 Jan 21.
PubMed 35074513Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
PubMed 30325565Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.
PubMed 37642285
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications
- ClinicalTrials.gov ID
- NCT06776718
- Acronym / sponsor ID
- 2021/514/214/25
- Keywords
- vNOTES, vaginal hysterectomy, benign gynecology, surgical outcomes, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.
A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vNOTES hysterectomy for benign indications | Experimental | Procedure: vNOTES |
| Vaginal hysterectomy for benign indications | Experimental | Procedure: vaginal hysterectomy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 40 and 80 years
- undergo hysterectomy for benign gynecological conditions
Key exclusion criteria (6 listed)
- history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
- suspected gynecologic malignancies,
- endometriosis,
- tubal-ovarian abscesses,
- pelvic organ prolapse exceeding grade 2,
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 |
|---|---|---|
| vNOTESvNOTES for benign hysterectomy | Procedure or surgery | vNOTES hysterectomy for benign indications |
| vaginal hysterectomyvaginal hysterectomy for benign hysterectomy | Procedure or surgery | Vaginal hysterectomy for benign indications |
Primary outcome
the duration of surgery
Time frame: The time from the beginning to the end of the operation
İnterval from initial incision to the completion of vaginal cuff closure (minute)
4 secondary outcomes
Hospitalization time
Time frame: through study completion, an average of 1 month
VAS score
Time frame: postoperative 6th and 24 th hour
Uterin volume
Time frame: through study completion, an average of 1 month
Re-admission
Time frame: within 1 month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 39084252Yildiz P, Keles E, Yildiz G, Birol Ilter P, Temocin RB, Kaya C, Mat E. Health-related quality of life following hysterectomy by vNOTES versus conventional laparoscopy. Minim Invasive Ther Allied Technol. 2024 Aug;33(4):232-236. doi: 10.1080/13645706.2024.2323100. Epub 2024 Mar 4.
- Background: PubMed 35074513Merlier M, Collinet P, Pierache A, Vandendriessche D, Delporte V, Rubod C, Cosson M, Giraudet G. Is V-NOTES Hysterectomy as Safe and Feasible as Outpatient Surgery Compared with Vaginal Hysterectomy? J Minim Invasive Gynecol. 2022 May;29(5):665-672. doi: 10.1016/j.jmig.2022.01.007. Epub 2022 Jan 21.
- Background: PubMed 30325565Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
- Background: PubMed 37642285Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vNOTES and vaginal hysterectomy in people with Hysterectomy and Hysterectomy, Benign Uterine Diseases, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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: opening soon, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gazi Yıldız, Assoc Prof (+905535288666, drgaziyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of surgery (time frame: The time from the beginning to the end of the operation). 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 NCT06776718, which also lists 4 linked publications.
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 15 Jan 2025.