Comparison of Performing V-Notes Hysterectomy Under Spinal Anesthesia and General Anesthesia (COPVNHSGA)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spinal Anesthesia Group
Participants undergoing v-notes hysterectomy under spinal anesthesia
|
V-notes hysterectomy performed under spinal anesthesia according to the study protocol
|
|
Active Comparator: General Anesthesia Group
participants undergoing v-notes hysterectomy under general anesthesia
|
V-notes hysterectomy performed under general anesthesia according to the study protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Postoperative Visual Analog Scale (VAS) pain score at 24 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 154/38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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