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ONSD as an ICP Marker in vNOTES and TLH

NCT07250178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    lead OTHER

Principal Investigators

  • Fatma Acil, M.D. · Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-27
Primary Completion
2026-01-02
Completion
2026-01-05

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07250178 on ClinicalTrials.gov