vNOTES vs Laparoscopic Hysterectomy: Randomized Trial on Pain and Recovery"
Comparison of vNOTES and Conventional Laparoscopic Hysterectomy: A Randomized Controlled Study of Pain, Opioid Use, and Quality of Recovery
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
56 participants
Jan 8, 2026
INTERVENTIONAL
Conditions
Summary
This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to evaluate whether vNOTES provides better postoperative comfort and recovery by reducing pain, lowering opioid analgesic requirements, and improving early recovery outcomes. Approximately 80 women undergoing elective hysterectomy will be randomly assigned to either vNOTES or TLH. All surgeries will be performed under standardized general anesthesia by the same experienced surgical team. Postoperative pain management will follow an identical protocol for all patients. Primary outcomes include postoperative pain scores (at 12 and 24 hours) and total opioid consumption. Secondary outcomes include Quality of Recovery-15 (QoR-15) scores, fatigue scores, time to first mobilization, time to first flatus, and length of hospital stay. The results of this study may help identify which hysterectomy technique offers better patient-centered recovery and postoperative comfort.
Eligibility
Inclusion Criteria5
- Female patients aged 18 to 75 years
- ASA physical status I-II
- Scheduled for elective laparoscopic hysterectomy (benign indications such as myoma uteri, adenomyosis, endometrial hyperplasia)
- Able to understand study procedures and provide written informed consent
- Able to complete postoperative questionnaires (QoR-15 and Fatigue Assessment Scale)
Exclusion Criteria8
- ASA III-IV status
- Severe cardiopulmonary disease or contraindication to general anesthesia
- Coagulopathy or bleeding disorders
- Active pelvic infection
- History of extensive pelvic or abdominal surgery complicating minimally invasive access
- Cognitive impairment or inability to complete questionnaires
- Conversion to laparotomy
- Known allergy or intolerance to study medications (paracetamol, tramadol)
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Interventions
Transluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port.
It is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars.
Locations(1)
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NCT07306507