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.
This study is a single-center, prospective, randomized controlled clinical trial designed to compare two minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to determine whether vNOTES offers advantages in postoperative pain control, opioid requirements, and early recovery outcomes by eliminating abdominal wall incisions and reducing pneumoperitoneum-related physiological effects. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey (Türkiye)
RECRUITINGPostoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: At 12 and 24 hours postoperatively
Need for Rescue Analgesia Within 24 Hours
The proportion of patients requiring rescue analgesia (intravenous tramadol 100 mg) after the standard regimen (paracetamol intravenously every 8 hours) will be recorded along with the number of rescue doses per patient.
Time frame: First 24 postoperative hours
Time to First Mobilization
Time from the end of surgery to the first ambulation out of bed will be recorded in hours.
Time frame: From the end of surgery until the first ambulation out of bed, assessed up to 48 hours postoperatively.
Time to First Flatus
Time from the end of surgery to the first passage of flatus will be recorded in hours as an indicator of return of bowel function.
Time frame: Time Frame: From the end of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days postoperatively or until hospital discharge, whichever comes first.
Length of Postoperative Hospital Stay
Length of stay will be calculated as the number of days from the day of surgery to the day of hospital discharge.
Time frame: Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first.
Change in QoR-15 Score from Baseline to 24 Hours
The Quality of Recovery-15 (QoR-15) questionnaire (total score 0-150; higher scores indicate better recovery) will be administered preoperatively and at 24 hours postoperatively. The primary analysis will focus on the change in total score from baseline to 24 hours.
Time frame: Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively
Change in Fatigue Assessment Scale (FAS) Score from Baseline to 24 Hours
Fatigue will be evaluated using the Fatigue Assessment Scale (FAS; total score 10-50, higher scores indicate greater fatigue). The change in total score from baseline to 24 hours will be analyzed.
Time frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
Postoperative nausea and vomiting will be recorded. Nausea severity will be assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no nausea and 10 indicates the worst imaginable nausea. Rescue antiemetic therapy will be administered if nausea severity is ≥4 or if vomiting occurs, and the need for rescue antiemetic treatment will be documented.
Time frame: During the first 24 hours postoperatively
Estimated Intraoperative Blood Loss
Estimated blood loss (EBL) will be calculated based on the volume of blood collected in the suction canister after subtraction of irrigation fluids, combined with visual estimation of blood absorbed by surgical sponges, as recorded in the anesthesia chart.
Time frame: During surgery
Postoperative Hemoglobin Decrease
Hemoglobin decrease will be calculated as the difference between preoperative hemoglobin level and postoperative hemoglobin level measured at 24 hours after surgery.
Time frame: From preoperative baseline to 24 hours postoperatively
Perioperative Blood Transfusion Requirement
The requirement for perioperative blood transfusion will be recorded as the administration of any packed red blood cells during surgery or within the first 24 hours postoperatively.
Time frame: During surgery and up to 24 hours postoperatively
Postoperative Delirium and Acute Cognitive Dysfunction
Postoperative delirium and acute cognitive dysfunction will be assessed using the 4AT (4 'A's Test) screening tool within the first 24 hours after surgery. The 4AT evaluates four domains: 1. Alertness (level of arousal), 2. AMT4 (abbreviated mental test: age, date of birth, place, and current year), 3. Attention (months of the year backwards), 4. Acute change or fluctuating course. Scores range from 0 to 12, with 0 indicating normal cognition, 1-3 suggesting possible cognitive impairment, and ≥4 indicating probable delirium. The incidence of postoperative delirium (4AT ≥4) and acute cognitive dysfunction (4AT ≥1) will be recorded and compared between the vNOTES and TLH groups.
Time frame: Within the first 24 hours postoperatively
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