ONSD as an ICP Marker in vNOTES and TLH

NCT07250178 | Completed

• 1 other identifier: 09/05/2025-627
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Abnormal Uterine Bleeding; Myoma;Uterus

Keywords

Laparoscopic Hysterectomy; vNOTES; Optic Nerve Sheath Diameter; Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

• 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).

  From baseline (before induction) to 10, 30, 60, and 90 minutes after Trendelenburg and CO₂ insufflation, and 10 minutes after desufflation.

Secondary Outcomes (9)

• 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.

Study Arms (2)

vNOTES Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter

EXPERIMENTAL

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 for Assessment of Intraoperative Optic Nerve Sheath Diameter

ACTIVE COMPARATOR

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

Interventions

vNOTES 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.

vNOTES Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter

TLH 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.

Total Laparoscopic Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Only female patients are eligible for inclusion, as the surgical procedures under investigation (vNOTES and total laparoscopic hysterectomy) are applicable solely to women undergoing gynecologic surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39010013 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Metrorrhagia; Myofibroma

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, prospective, randomized controlled trial with a parallel assignment design. Eligible patients undergoing elective laparoscopic hysterectomy will be randomly allocated in a 1:1 ratio to either the vNOTES group or the TLH group. Randomization will be performed using a computer-generated sequence, and allocation concealment will be maintained with sealed opaque envelopes. Each participant will receive only one surgical intervention.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 27, 2025
• Primary Completion: January 2, 2026
• Study Completion: January 5, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: study completion + 6 months
• Access Criteria: Researchers may request access to the de-identified IPD by contacting the principal investigator at:\[acilfatma@gmail.com\]. Requests will be evaluated by the investigators, and data will be shared after approval and completion of a data-sharing agreement."

Locations

TU (1)