Regional Anesthesia MorbidityNCT06528886
V-notes Hysterectomy With Regional Anesthesia
A study testing hysterectomy by V-NOTES in people with Regional Anesthesia Morbidity, run by Sanliurfa Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- hysterectomy by V-NOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Nov 2024
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients contraindicated for spinal anesthesia or pneumoperitoneum, those with a history of tubo-ovarian abscess, deep endometriosis or suspected pelvic adhesions
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sanliurfa Education and Research Hospital
Sanliurfa, 63250
Sanliurfa Education and Research Hospital
Sanliurfa
About this study
Official title: V-notes (Transluminal Endoscopic Surgery Through Natural Orifices) Hysterectomy With Regional Anesthesia
Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Regional anesthesia is known to be the most comfortable anesthesia type and has less pain, nausea and vomiting during postoperative recovery. Our aim in this study is to evaluate the results by performing the surgery under regional anesthesia.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- hysterectomy by V-NOTES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterectomy by V-NOTESProcedure or surgery
V-notes is like laparoscopy via the vaginal route.
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | Experimental | hysterectomy will be done by V-NOTES under regional anesthesia . Receives: Procedure: hysterectomy by V-NOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
vas score
Measured: postoperative first 24 hours
complications
bleeding, transfusion
Measured: postoperative first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- alev esercan, MD, Study director, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528886
- Sponsor's protocol ID
- Seah-2-63
- Status last verified
- Apr 2025
- First submitted
- 26 Jul 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V-notes (Transluminal Endoscopic Surgery Through Natural Orifices) Hysterectomy With Regional Anesthesia
- ClinicalTrials.gov ID
- NCT06528886
- Acronym / sponsor ID
- Seah-2-63
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 30 Jul 2024 (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.
Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Regional anesthesia is known to be the most comfortable anesthesia type and has less pain, nausea and vomiting during postoperative recovery. Our aim in this study is to evaluate the results by performing the surgery under regional anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | Experimental | Procedure: hysterectomy by V-NOTEShysterectomy will be done by V-NOTES under regional anesthesia . |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients contraindicated for spinal anesthesia or pneumoperitoneum, those with a history of tubo-ovarian abscess, deep endometriosis or suspected pelvic adhesions
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 |
|---|---|---|
| hysterectomy by V-NOTESV-notes is like laparoscopy via the vaginal route. | Procedure or surgery | regional anesthesia |
Primary outcome
pain score
Time frame: postoperative first 24 hours
vas score
complications
Time frame: postoperative first 24 hours
bleeding, transfusion
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 8 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
alev esercan, MD study director
Sanliurfa Education and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysterectomy by V-NOTES in people with Regional Anesthesia Morbidity, run by Sanliurfa Education and Research Hospital at 2 sites 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 0 inclusion and 1 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
pain score (time frame: postoperative first 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.