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Not yet recruitingNCT07758504COPVNHSGAUpdated Aug 11, 2026

Comparison of Performing V-Notes Hysterectomy Under Spinal Anesthesia and General Anesthesia

An interventional study of Vnotes hysterectomy under spinal anesthesia and Vnotes hysterectomy under general anesthesia in Hysterectomy for Abnormal Uterine Bleeding, sponsored by Cukurova University. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Cukurova University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Sex
Female
01

Study 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 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

02

Conditions studied

  • Hysterectomy for Abnormal Uterine Bleeding

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Keywords

  • V-NOTES
  • HYSTERECTOMY
  • SPİNAL ANESTHESİA
03

In context

Uterine Hemorrhage

90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.

This study's planned enrollment of 28 is below the median of 100 across 62 interventional studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

(ASA) physical status classification I-II

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Spinal Anesthesia Group

    Participants undergoing v-notes hysterectomy under spinal anesthesia

    Procedure: Vnotes hysterectomy under spinal anesthesia

  • Active comparator
    General Anesthesia Group

    participants undergoing v-notes hysterectomy under general anesthesia

    Procedure: Vnotes hysterectomy under general anesthesia

Interventions

  • ProcedureVnotes hysterectomy under spinal anesthesia

    V-notes hysterectomy performed under spinal anesthesia according to the study protocol

  • ProcedureVnotes hysterectomy under general anesthesia

    V-notes hysterectomy performed under general anesthesia according to the study protocol

06

What researchers measure

Primary outcomes

  1. Pain score

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating worse pain.

    Time frame: Postoperative Visual Analog Scale (VAS) pain score at 24 hour

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Oct 2027, 14 months later.

Of 17 interventional studies with no phase under Uterine Hemorrhage, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 14 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 11, 2026
StartEst.
Jul 14, 2026
Primary completionEst.
Oct 10, 2027
CompletionEst.
Oct 10, 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07758504
Responsible party
Ghanim Khatib (Professor, Cukurova University) — Principal investigator
First posted
Aug 11, 2026
Start date
Jul 14, 2026 (estimated)
Primary completion
Oct 10, 2027 (estimated)
Completion
Oct 10, 2027 (estimated)
Last update
Aug 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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