NCT06528886

Brief Summary

Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Regional anesthesia is known to be the most comfortable anesthesia type and has less pain, nausea and vomiting during postoperative recovery. Our aim in this study is to evaluate the results by performing the surgery under regional anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

July 26, 2024

Last Update Submit

April 4, 2025

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (2)

  • pain score

    vas score

    postoperative first 24 hours

  • complications

    bleeding, transfusion

    postoperative first 24 hours

Study Arms (1)

regional anesthesia

EXPERIMENTAL

hysterectomy will be done by V-NOTES under regional anesthesia .

Procedure: hysterectomy by V-NOTES

Interventions

hysterectomy by V-NOTESPROCEDURE

V-notes is like laparoscopy via the vaginal route.

regional anesthesia

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailshysterectomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients contraindicated for spinal anesthesia or pneumoperitoneum, those with a history of tubo-ovarian abscess, deep endometriosis or suspected pelvic adhesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanliurfa Education and Research Hospital

Sanliurfa, 63250, Turkey (Türkiye)

Location

Sanliurfa Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

Study Officials

  • alev esercan, MD

    Sanliurfa Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 30, 2024

Study Start

July 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

TU(2)