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
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.
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
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 →Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.
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(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
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing v-notes hysterectomy under spinal anesthesia
Procedure: Vnotes hysterectomy under spinal anesthesia
participants undergoing v-notes hysterectomy under general anesthesia
Procedure: Vnotes hysterectomy under general anesthesia
V-notes hysterectomy performed under spinal anesthesia according to the study protocol
V-notes hysterectomy performed under general anesthesia according to the study protocol
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
No study locations are listed for this record.
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.
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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