Hysterectomy
Conditions
Keywords
vNOTES, Total Laparoscopic Hysterectomy, Postoperative Pain, Enhanced Recovery
Brief 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.
Detailed description
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.
Interventions
PROCEDUREvNOTES Hysterectomy
Transluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port.
PROCEDURETotal Laparoscopic Hysterectomy
It is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators responsible for postoperative data collection and analysis and outcome assessors were blinded to group allocation. These investigators were not involved in the surgical or anesthetic management of the patients. Due to the nature of the surgical procedures, blinding of participants and care providers was not feasible.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to undergo either vNOTES hysterectomy or conventional total laparoscopic hysterectomy. Each participant receives only one of the two surgical interventions, and both groups are followed in parallel for outcome assessment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity (NRS) | At 12 and 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Rescue Analgesia Within 24 Hours | First 24 postoperative 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 to First Mobilization | From the end of surgery until the first ambulation out of bed, assessed up to 48 hours postoperatively. | Time from the end of surgery to the first ambulation out of bed will be recorded in hours. |
| Time to First Flatus | 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. | 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. |
| Length of Postoperative Hospital Stay | Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first. | Length of stay will be calculated as the number of days from the day of surgery to the day of hospital discharge. |
| Change in QoR-15 Score from Baseline to 24 Hours | Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively | 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. |
| Change in Fatigue Assessment Scale (FAS) Score from Baseline to 24 Hours | Preoperative (within 24 hours before surgery) and 24 hours postoperatively | 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. |
| Postoperative Nausea and Vomiting (PONV) | During the first 24 hours postoperatively | 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. |
| Postoperative Hemoglobin Decrease | From preoperative baseline to 24 hours postoperatively | Hemoglobin decrease will be calculated as the difference between preoperative hemoglobin level and postoperative hemoglobin level measured at 24 hours after surgery. |
| Postoperative Delirium and Acute Cognitive Dysfunction | Within the first 24 hours postoperatively | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORFatma Acil, M.D.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Outcome results
None listed