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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07758504
Acronym
COPVNHSGA
Enrollment
28
Registered
2026-08-11
Start date
2026-07-14
Completion date
2027-10-10
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy for Abnormal Uterine Bleeding

Keywords

V-NOTES, HYSTERECTOMY, SPİNAL ANESTHESİA

Brief 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.

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

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

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

American Society of Anesthesiologists (ASA) physical status classification I-II

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scorePostoperative Visual Analog Scale (VAS) pain score at 24 hourPain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating worse pain.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026