ONSD as an ICP Marker in vNOTES and TLH

NCT ID: NCT07250178

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-27
• Study Completion Date: 2026-01-05

Brief Summary

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.

Detailed Description

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.

Conditions

Endometrial Cancer; Abnormal Uterine Bleeding; Myoma;Uterus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

vNOTES

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

TLH

Intervention Type: PROCEDURE

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.

Interventions

vNOTES

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• voluntary participation,
• elective laparoscopic hysterectomy scheduled by gynecology-oncology specialists,
• ASA physical status I-II

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fatma Acil,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Acil, M.D.

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Locations

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Outside of the US, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Guloglu H, Cetinkaya D, Oge T, Bilir A. Evaluation of the effect of trendelenburg position duration on intracranial pressure in laparoscopic hysterectomies using ultrasonographic optic nerve sheath diameter measurements. BMC Anesthesiol. 2024 Jul 15;24(1):238. doi: 10.1186/s12871-024-02624-4.

Reference Type: BACKGROUND

PMID: 39010013 (View on PubMed)

Other Identifiers

09/05/2025-627

Identifier Type: -

Identifier Source: org_study_id