Hysterectomy Clinical Trials

Clinical trials related to Hysterectomy Procedure

Comparison of vNOTES and Conventional Laparoscopic Hysterectomy: A Randomized Controlled Study of Pain, Opioid Use, and Quality of Recovery

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

This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to evaluate whether vNOTES provides better postoperative comfort and recovery by reducing pain, lowering opioid analgesic requirements, and improving early recovery outcomes. Approximately 80 women undergoing elective hysterectomy will be randomly assigned to either vNOTES or TLH. All surgeries will be performed under standardized general anesthesia by the same experienced surgical team. Postoperative pain management will follow an identical protocol for all patients. Primary outcomes include postoperative pain scores (at 12 and 24 hours) and total opioid consumption. Secondary outcomes include Quality of Recovery-15 (QoR-15) scores, fatigue scores, time to first mobilization, time to first flatus, and length of hospital stay. The results of this study may help identify which hysterectomy technique offers better patient-centered recovery and postoperative comfort.

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

• Female patients aged 18 to 75 years

• ASA physical status I-II

• Scheduled for elective laparoscopic hysterectomy (benign indications such as myoma uteri, adenomyosis, endometrial hyperplasia)

• Able to understand study procedures and provide written informed consent

• Able to complete postoperative questionnaires (QoR-15 and Fatigue Assessment Scale)

Locations
Other Locations
Turkey
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır
Time Frame
Start Date: 2026-01-08
Completion Date: 2026-04-10
Participants
Target number of participants: 90
Treatments
Experimental: vNOTES Group
Patients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg.
Active_comparator: TLH Group
Patients undergo conventional total laparoscopic hysterectomy using a camera port and accessory trocars from the umbilicus, and pneumoperitoneum is maintained at a pressure not exceeding 15 mmHg.
Related Therapeutic Areas
Sponsors
Leads: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

This content was sourced from clinicaltrials.gov