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

NCT07758504 — Not applicable, Not yet recruiting, 28 participants, Cukurova University

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RegistryNCT07758504, acronym COPVNHSGA
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment28 (Estimated)
SponsorCukurova University (Other)
ConditionsHysterectomy for Abnormal Uterine Bleeding
InterventionsVnotes hysterectomy under spinal anesthesia, Vnotes hysterectomy under general anesthesia (Procedure)
Datesstart 2026-07-14 (estimated), primary completion 2027-10-10 (estimated), completion 2027-10-10 (estimated), first posted 2026-08-11, last updated 2026-08-11

Related Papers Related Patents Related Grants Related Experts
All trials for Hysterectomy for Abnormal Uterine Bleeding All trials of Vnotes hysterectomy under spinal anesthesia All trials of Vnotes hysterectomy under general anesthesia

-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
Spinal Anesthesia GroupExperimentalProcedure: Vnotes hysterectomy under spinal anesthesiaParticipants undergoing v-notes hysterectomy under spinal anesthesia
General Anesthesia GroupActive comparatorProcedure: Vnotes hysterectomy under general anesthesiaparticipants undergoing v-notes hysterectomy under general anesthesia
  • Vnotes hysterectomy under spinal anesthesia (Procedure): V-notes hysterectomy performed under spinal anesthesia according to the study protocol
  • Vnotes hysterectomy under general anesthesia (Procedure): V-notes hysterectomy performed under general anesthesia according to the study protocol

+Outcome measures

Primary outcomes

  • Pain score [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.

+Eligibility

Sex: Female

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