Hysterectomy for Abnormal Uterine BleedingCOPVNHSGANCT07758504
Comparison of Performing V-Notes Hysterectomy Under Spinal Anesthesia and General Anesthesia
A study testing Vnotes hysterectomy under spinal anesthesia and Vnotes hysterectomy under general anesthesia in people with Hysterectomy for Abnormal Uterine Bleeding, run by Cukurova University.
Trial summary
Vaginal natural orifice transluminal endoscopic surgery is recognized as a significant advancement in women's health, representing an extension of minimally invasive surgery. Research and clinical experience with this technique are ongoing, contributing to its increasing adoption as a suitable option for a broader… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy for Abnormal Uterine Bleeding
- What is being tested?
- Vnotes hysterectomy under spinal anesthesia and Vnotes hysterectomy under general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2026to 10 Oct 2027
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification I-II
Who cannot join
- History of tubo-ovarian abscess
- Presence or history of deep endometriosis
- Suspected pelvic adhesions
- Nodule in the pouch of Douglas
- Fixed uterus
- Sexually inactive patients
About this study
Vaginal natural orifice transluminal endoscopic surgery is recognized as a significant advancement in women's health, representing an extension of minimally invasive surgery. Research and clinical experience with this technique are ongoing, contributing to its increasing adoption as a suitable option for a broader patient population.
The aim of this study is to evaluate vaginal natural orifice transluminal endoscopic surgery hysterectomy performed under general anesthesia versus regional anesthesia in terms of surgical comfort, length of hospital stay, postoperative pain, and other relevant clinical outcomes, as well as to compare patients' recovery times.
Read the detailed description
Hysterectomy remains one of the most commonly performed surgical procedures in gynecology and is the second most frequently performed operation after cesarean section. Advances in minimally invasive surgery have led to the development of techniques aimed at reducing surgical trauma and improving patient outcomes. Vaginal natural orifice transluminal endoscopic surgery (V-NOTES) has emerged as a novel approach that combines the benefits of vaginal surgery and laparoscopy and is increasingly recognized as a safe and effective technique in gynecologic practice.
Despite improvements in surgical techniques, the choice of anesthesia remains a critical factor influencing perioperative outcomes. General anesthesia and regional (spinal) anesthesia are both widely used; however, comparative data regarding their effects in V-NOTES hysterectomy are limited.
This prospective observational study aims to compare V-NOTES hysterectomy performed under general anesthesia and regional (spinal) anesthesia. A total of 28 patients undergoing V-NOTES hysterectomy at our institution will be included and grouped according to the type of anesthesia administered.
Inclusion criteria include voluntary participation, provision of written informed consent, and preoperative evaluation confirming suitability for V-NOTES hysterectomy at the Çukurova University Balcalı Hospital, Department of Obstetrics and Gynecology. Exclusion criteria include a history of tubo-ovarian abscess, presence or history of deep endometriosis, suspected pelvic adhesions, nodules in the pouch of Douglas, a fixed uterus, sexual inactivity, and refusal to provide informed consent.
Preoperative data will include arterial blood pressure, vital signs, indication for hysterectomy, primary complaint, menopausal status, body mass index (BMI), gravidity, parity, comorbidities, number of previous surgeries, and American Society of Anesthesiologists (ASA) physical status classification. Intraoperative parameters will include additional surgical procedures, surgical comfort, duration of surgery, and type of anesthesia. Postoperative outcomes will include Visual Analog Scale (VAS) pain scores, headache, shoulder pain, nausea, vomiting, and length of hospital stay.
The primary objective is to evaluate differences between anesthesia techniques in terms of surgical comfort, postoperative pain, and length of hospital stay. Secondary outcomes include comparisons of recovery parameters and perioperative outcomes. This study is expected to contribute to optimizing anesthesia selection for V-NOTES hysterectomy and improving patient care.
Primary outcome:
Postoperative Visual Analog Scale (VAS) pain score at 0-24 hours
Secondary outcomes:
Total analgesic consumption within 24 hours Length of hospital stay Surgical comfort, assessed using a standardized scale Postoperative adverse effects, assessed as a composite outcome
- Being tested
- Vnotes hysterectomy under spinal anesthesia, Vnotes hysterectomy under general anesthesia
- Keywords
- V-NOTES, HYSTERECTOMY, SPİNAL ANESTHESİA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vnotes hysterectomy under spinal anesthesiaProcedure or surgery
V-notes hysterectomy performed under spinal anesthesia according to the study protocol
Vnotes hysterectomy under general anesthesiaProcedure or surgery
V-notes hysterectomy performed under general anesthesia according to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia Group | Experimental | Participants undergoing v-notes hysterectomy under spinal anesthesia Receives: Procedure: Vnotes hysterectomy under spinal anesthesia |
| General Anesthesia Group | Active comparator | participants undergoing v-notes hysterectomy under general anesthesia Receives: Procedure: Vnotes hysterectomy under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating worse pain.
Measured: Postoperative Visual Analog Scale (VAS) pain score at 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start14 Jul 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterectomy for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghanim Khatib, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758504
- Sponsor's protocol ID
- 154/38
- Acronym
- COPVNHSGA
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Performing V-Notes Hysterectomy Under Spinal Anesthesia and General Anesthesia
- ClinicalTrials.gov ID
- NCT07758504
- Acronym / sponsor ID
- COPVNHSGA / 154/38
- Keywords
- V-NOTES, HYSTERECTOMY, SPİNAL ANESTHESİA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 14 Jul 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 11 Aug 2026 (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.
Vaginal natural orifice transluminal endoscopic surgery is recognized as a significant advancement in women's health, representing an extension of minimally invasive surgery. Research and clinical experience with this technique are ongoing, contributing to its increasing adoption as a suitable option for a broader patient population.
The aim of this study is to evaluate vaginal natural orifice transluminal endoscopic surgery hysterectomy performed under general anesthesia versus regional anesthesia in terms of surgical comfort, length of hospital stay, postoperative pain, and other relevant clinical outcomes, as well as to compare patients' recovery times.
Detailed description
Hysterectomy remains one of the most commonly performed surgical procedures in gynecology and is the second most frequently performed operation after cesarean section. Advances in minimally invasive surgery have led to the development of techniques aimed at reducing surgical trauma and improving patient outcomes. Vaginal natural orifice transluminal endoscopic surgery (V-NOTES) has emerged as a novel approach that combines the benefits of vaginal surgery and laparoscopy and is increasingly recognized as a safe and effective technique in gynecologic practice.
Despite improvements in surgical techniques, the choice of anesthesia remains a critical factor influencing perioperative outcomes. General anesthesia and regional (spinal) anesthesia are both widely used; however, comparative data regarding their effects in V-NOTES hysterectomy are limited.
This prospective observational study aims to compare V-NOTES hysterectomy performed under general anesthesia and regional (spinal) anesthesia. A total of 28 patients undergoing V-NOTES hysterectomy at our institution will be included and grouped according to the type of anesthesia administered.
Inclusion criteria include voluntary participation, provision of written informed consent, and preoperative evaluation confirming suitability for V-NOTES hysterectomy at the Çukurova University Balcalı Hospital, Department of Obstetrics and Gynecology. Exclusion criteria include a history of tubo-ovarian abscess, presence or history of deep endometriosis, suspected pelvic adhesions, nodules in the pouch of Douglas, a fixed uterus, sexual inactivity, and refusal to provide informed consent.
Preoperative data will include arterial blood pressure, vital signs, indication for hysterectomy, primary complaint, menopausal status, body mass index (BMI), gravidity, parity, comorbidities, number of previous surgeries, and American Society of Anesthesiologists (ASA) physical status classification. Intraoperative parameters will include additional surgical procedures, surgical comfort, duration of surgery, and type of anesthesia. Postoperative outcomes will include Visual Analog Scale (VAS) pain scores, headache, shoulder pain, nausea, vomiting, and length of hospital stay.
The primary objective is to evaluate differences between anesthesia techniques in terms of surgical comfort, postoperative pain, and length of hospital stay. Secondary outcomes include comparisons of recovery parameters and perioperative outcomes. This study is expected to contribute to optimizing anesthesia selection for V-NOTES hysterectomy and improving patient care.
Primary outcome:
Postoperative Visual Analog Scale (VAS) pain score at 0-24 hours
Secondary outcomes:
Total analgesic consumption within 24 hours Length of hospital stay Surgical comfort, assessed using a standardized scale Postoperative adverse effects, assessed as a composite outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Group | Experimental | Procedure: Vnotes hysterectomy under spinal anesthesiaParticipants undergoing v-notes hysterectomy under spinal anesthesia |
| General Anesthesia Group | Active comparator | Procedure: Vnotes hysterectomy under general anesthesiaparticipants undergoing v-notes hysterectomy under general anesthesia |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status classification I-II
Key exclusion criteria (6 listed)
- History of tubo-ovarian abscess
- Presence or history of deep endometriosis
- Suspected pelvic adhesions
- Nodule in the pouch of Douglas
- Fixed uterus
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 |
|---|---|---|
| Vnotes hysterectomy under spinal anesthesiaV-notes hysterectomy performed under spinal anesthesia according to the study protocol | Procedure or surgery | Spinal Anesthesia Group |
| Vnotes hysterectomy under general anesthesiaV-notes hysterectomy performed under general anesthesia according to the study protocol | Procedure or surgery | General Anesthesia Group |
Primary outcome
Pain score
Time frame: Postoperative Visual Analog Scale (VAS) pain score at 24 hour
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating worse pain.
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 11 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vnotes hysterectomy under spinal anesthesia and Vnotes hysterectomy under general anesthesia in people with Hysterectomy for Abnormal Uterine Bleeding, run by Cukurova University.
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 1 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Visual Analog Scale (VAS) pain score at 24 hour). 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 11 Aug 2026.