vNOTES vs Laparoscopic Hysterectomy: Randomized Trial on Pain and Recovery"
NCT ID: NCT07306507
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2025-12-16
2025-12-30
Brief Summary
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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.
Detailed Description
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Eligible ASA I-II female patients aged 18-75 scheduled for elective hysterectomy are randomly assigned in a 1:1 ratio to the vNOTES or TLH group using a computer-generated sequence with sealed opaque envelopes for allocation concealment. All procedures are performed by the same experienced surgical and anesthesia team using a standardized general anesthesia protocol. Postoperative analgesia and recovery care are identical for both groups to ensure uniformity of perioperative management.
In the vNOTES group, hysterectomy is performed via transvaginal access using a self-retaining vaginal port, with pneumoperitoneum pressure kept at or below 15 mmHg. In the TLH group, a standard laparoscopic approach using a 10 mm umbilical port and two 5 mm accessory trocars is applied, with pneumoperitoneum maintained between 12-15 mmHg. Trendelenburg positioning is used in both techniques but is expected to be less steep and shorter in duration in the vNOTES group.
Outcome assessment is conducted by nurses and clinicians blinded to group allocation. Primary endpoints include postoperative pain scores at 12 and 24 hours (measured using a 0-10 Visual Analog Scale) and total opioid consumption within the first 24 hours. Secondary endpoints include Quality of Recovery-15 (QoR-15) scores, Fatigue Assessment Scale (FAS) scores, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications such as nausea/vomiting, shoulder pain, and respiratory discomfort. The study is powered based on a one-tailed hypothesis expecting lower postoperative discomfort in the vNOTES group.
The findings of this trial may help clarify whether vNOTES provides superior postoperative comfort and enhanced recovery compared to standard laparoscopic hysterectomy, contributing evidence to guide technique selection in minimally invasive gynecologic surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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vNOTES Group
Patients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg.
vNOTES Hysterectomy
Transluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port.
TLH Group
Patients undergo conventional total laparoscopic hysterectomy using a camera port and accessory trocars from the umbilicus, and pneumoperitoneum is maintained at a pressure not exceeding 15 mmHg.
Total Laparoscopic Hysterectomy
It is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars.
Interventions
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vNOTES Hysterectomy
Transluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port.
Total Laparoscopic Hysterectomy
It is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
75 Years
FEMALE
No
Sponsors
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
OTHER
Responsible Party
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Fatma Acil,MD
Principal Investigator
Principal Investigators
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Fatma Acil, M.D.
Role: PRINCIPAL_INVESTIGATOR
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Locations
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Fatma Acil, M.D.
Role: primary
Hülya Tosun Söner, M.D.
Role: backup
References
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Fang S, Xia Y, Jin J, Zhang J, Lu L. Comparison of Surgical Outcomes Between Vaginally Assisted NOTES Hysterectomy and Laparoscopic Hysterectomy in Primary Hospitals: A Prospective Cohort Study. J Invest Surg. 2025 Dec;38(1):2515054. doi: 10.1080/08941939.2025.2515054. Epub 2025 Jun 10.
Other Identifiers
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11/7/2025-705
Identifier Type: -
Identifier Source: org_study_id