An interventional study of vNOTES and TLH in Endometrial Cancer, Abnormal Uterine Bleeding and Myoma;Uterus, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Treatment
Patients undergoing conventional total laparoscopic hysterectomy (TLH) are typically placed in the Trendelenburg position with intraabdominal carbon dioxide (CO₂) insufflation. These factors may contribute to intraoperative complications such as lymphedema, impaired pulmonary function, and increased intracranial pressure.
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), a novel minimally invasive technique, provides retroperitoneal or transperitoneal access through the vaginal route and offers the potential for shorter operative times and lower intraabdominal pressure requirements.
This study aims to evaluate whether the vNOTES technique can reduce intraoperative and postoperative complications compared with TLH. Particular attention will be given to hemodynamic parameters and changes in optic nerve sheath diameter as an indirect indicator of intracranial pressure.
This study is designed as a single-center, prospective, randomized controlled trial conducted at the Gynecologic Oncology Clinic of Health Sciences University Diyarbakır Gazi Yaşargil Training and Research Hospital. Eligible patients will be women between 18 and 75 years of age, classified as ASA I-II, who are scheduled for elective laparoscopic hysterectomy for gynecologic oncology indications. The study protocol will be initiated after approval by the institutional ethics committee, and written informed consent will be obtained from all participants.
Group vNOTES: Following vaginal exposure with a speculum under general anesthesia, entry will be performed through the posterior vaginal fornix. After posterior colpotomy, the vNOTES port system will be inserted. Pneumoperitoneum will be established with CO₂ insufflation at a maximum pressure of 15 mmHg. The operation will be performed using an endoscopic camera and working channels.
Group TLH: Under general anesthesia, pneumoperitoneum will be created via an umbilical trocar (maximum pressure15 mmHg), followed by placement of 2-3 additional trocars in the lower abdomen. A standard total laparoscopic hysterectomy will then be performed.
Demographic and perioperative data will be collected, including age, diagnosis, ASA score, anesthesia and surgery duration, intraoperative blood loss (by suction and sponge count), total intravenous fluids, systolic and diastolic blood pressure, heart rate, oxygen saturation, respiratory rate, end-tidal CO₂, intra-abdominal pressure, and ventilatory parameters (PEEP, peak and plateau airway pressures).
The primary outcome will be changes in optic nerve sheath diameter (ONSD), measured by ultrasonography at predefined time points as a surrogate marker of intracranial pressure:
T0: before induction of anesthesia
T1: at 10 minutes after Trendelenburg positioning and insufflation
T2: at 30 minutes
T3: at 60 minutes
T4: at 90 minutes
T5: 10 minutes after desufflation and return to neutral position
All ONSD measurements will be performed intraoperatively by a trained anesthesiologist using standardized ultrasound techniques. Hemodynamic and ventilatory parameters will be recorded at 10-minute intervals.
Secondary outcomes will include arterial blood gas analysis, postoperative complications (such as nausea, vomiting, delirium, headache, dizziness, and diplopia), and recovery variables (time to ambulation, return of bowel function, oral intake, and hospital stay).
Among the parameters measured, ONSD evaluation via ultrasound is specific to the study and non-invasive, adding no risk or cost to the patient. All other parameters are part of routine intraoperative monitoring. Data collection will be carried out in the operating room by anesthesiologists and trained ICU/gynecologic oncology nurses.
The investigators hypothesize that the vNOTES approach, due to its shorter operative duration, reduced Trendelenburg requirements, and lower intraabdominal insufflation pressures, will result in less pronounced increases in ONSD compared with TLH. This may lead to greater intraoperative stability and reduced postoperative complications, thereby providing valuable evidence for optimizing surgical strategies in gynecologic oncology.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
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Exclusion Criteria:
Vajinal natural orifice transluminal endoscopic surgery (vNOTES): In the vNOTES group, the surgery was performed using a transvaginal approach with a self-retaining vaginal port. Following colpotomy, CO₂ insufflation was applied through the vaginal port, ensuring intra-abdominal pressure did not exceed 15 mmHg. The procedure involved occlusion and ligation of the uterine artery under direct endoscopic visualization, followed by sampling through the vaginal route. Pneumoperitoneum was released before closing the vaginal vault. The uterus was then removed through the vaginal route.
Procedure: vNOTES
Total laparoscopic hysterectomy (TLH): In the TLH group, the surgical procedure was performed under standard laparoscopic conditions using a 10 mm umbilical camera port and two 5 mm accessory trocars. CO₂ insufflation was initiated to maintain intra-abdominal pressure below 15 mmHg. The uterus is dissected using a bipolar vessel sealing device, and the specimen is removed transvaginally. The vaginal cuff and abdominal trocar entries are sutured laparoscopically under direct visualization.
Procedure: TLH
vNOTES: In the vNOTES group, the surgery was performed using a transvaginal approach with a self-retaining vaginal port. Following colpotomy, CO₂ insufflation was applied through the vaginal port, ensuring intra-abdominal pressure did not exceed 15 mmHg. The procedure involved occlusion and ligation of the uterine artery under direct endoscopic visualization, followed by sampling through the vaginal route. Pneumoperitoneum was released before closing the vaginal vault. The uterus was then removed through the vaginal route.
In the TLH group, the surgical procedure was performed under standard laparoscopic conditions using a 10 mm umbilical camera port and two 5 mm accessory trocars. CO₂ insufflation was initiated to maintain intra-abdominal pressure below 15 mmHg. The uterus is dissected using a bipolar vessel sealing device, and the specimen is removed transvaginally. The vaginal cuff and abdominal trocar entries are sutured laparoscopically under direct visualization.
Optic nerve sheath diameter (ONSD) measured
All measurements were performed using a high-resolution ultrasound device equipped with a 7-13 MHz linear probe. The ultrasound gain and depth settings were standardized for all patients (depth: 4-5 cm; focus: at the level of the optic disc). Patient Position: Measurements were obtained with patients in the supine position. The eyes were kept closed, and sterile ultrasound gel was applied without exerting pressure on the globe. The probe was gently placed on the upper eyelid, and measurements were taken in the transverse plane. The optic nerve sheath diameter was measured 3 mm distal to the optic disc, from outer edge to outer edge (outer-to-outer).
Time frame: From baseline (before induction) to 10, 30, 60, and 90 minutes after Trendelenburg and CO₂ insufflation, and 10 minutes after desufflation.
Blood pressure measurement
Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Measurement of heart rate
The number of heart beats per minute obtained by electrocardiographic monitoring
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
intraabdominal pressure
The pressure inside the abdominal cavity during CO₂ insufflation.
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
end-tidal CO₂ (EtCO₂)
The partial pressure of CO₂ at end-expiration measured by capnography
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
peak airway pressure
The highest pressure reached in the airways during inspiration under mechanical ventilation.
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Nausea-vomiting
Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
Time frame: During the 24 hours postoperative period
dizziness
Questioning about the presence/absence of dizzines the postoperative period
Time frame: During the 24 hours postoperative period
diplopia
Questioning about the presence/absence of diplopia the postoperative period
Time frame: During the 24 hours postoperative period
Incidence of Postoperative Headache
The incidence of postoperative headache will be recorded within the first 24 hours after surgery. Headache will be assessed by direct patient questioning and documented as present or absent.
Time frame: Within the first 24 hours postoperatively
Plan to share: Yes — De-identified individual participant data (IPD), including baseline demographic variables and primary/secondary outcome measures, will be shared.
Supporting information: Study protocol, Icf
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital