NCT07250178Completed
ONSD as an ICP Marker in vNOTES and TLH
Effect of Surgical Approach on Optic Nerve Sheath Diameter as a Surrogate Marker of Intracranial Pressure: A Comparison Between vNOTES and Total Laparoscopic Hysterectomy
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 18 Nov 2025
- Start date
- 27 Nov 2025
- Primary completion date
- 2 Jan 2026
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Diseases
- Endometrial cancer
- NCT number
- NCT07250178
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 27 Nov 2025 to the primary completion date, 2 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- emergency surgery,
- prior major pelvic or abdominal surgery,
- 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.
Age
- age \<18 years,
Other
- included unwillingness to participate,
- ASA ≥III,
Who the study is looking for
- voluntary participation,
- elective laparoscopic hysterectomy scheduled by gynecology-oncology specialists,
- ASA physical status I-II
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.