Effect of Surgical Approach on Optic Nerve Sheath Diameter as a Surrogate Marker of Intracranial Pressure: A Comparison Between vNOTES and Total Laparoscopic Hysterectomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• voluntary participation,

• elective laparoscopic hysterectomy scheduled by gynecology-oncology specialists,

• ASA physical status I-II

Locations
Other Locations
Turkey
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
RECRUITING
Diyarbakır
Contact Information
Primary
Fatma Acil, M.D
acilfatma@gmail.com
+905337225225
Backup
Fatma Acil, M.D.
acilfatma@gmail.com
+905337225225
Time Frame
Start Date: 2025-11-27
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 56
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

This content was sourced from clinicaltrials.gov