Effect of Surgical Approach on Optic Nerve Sheath Diameter as a Surrogate Marker of Intracranial Pressure: A Comparison Between vNOTES and Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Optic nerve sheath diameter (ONSD) measured
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the surgical interventions, blinding is not feasible. Both surgeons and outcome assessors are aware of group allocation. Participants may also recognize their assigned intervention based on the operative approach.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •voluntary participation,
- •elective laparoscopic hysterectomy scheduled by gynecology-oncology specialists,
- •ASA physical status I-II
排除标准
- •included unwillingness to participate,
- •emergency surgery,
- •age <18 years,
- •prior major pelvic or abdominal surgery,
- •ASA ≥III,
- •Chronic pulmonary disease, pulmonary hypertension, glaucoma, diabetic retinopathy, intracranial pathology (mass, hydrocephalus, optic neuritis), prior ocular or intracranial surgery, cardiac failure (EF <40%), active infection, or systemic inflammatory diseases other than malignancy.
研究组 & 干预措施
vNOTES Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter
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.
干预措施: vNOTES (Procedure)
Total Laparoscopic Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter
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.
干预措施: TLH (Procedure)
结局指标
主要结局
Optic nerve sheath diameter (ONSD) measured
时间窗: From baseline (before induction) to 10, 30, 60, and 90 minutes after Trendelenburg and CO₂ insufflation, and 10 minutes after desufflation.
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).
次要结局
- Blood pressure measurement(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(It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.)
- intraabdominal pressure(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)(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(It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.)
- Nausea-vomiting(During the 24 hours postoperative period)
- dizziness(During the 24 hours postoperative period)
- diplopia(During the 24 hours postoperative period)
- Incidence of Postoperative Headache(Within the first 24 hours postoperatively)
研究者
Fatma Acil,MD
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital