V-notes Hysterectomy With Regional Anesthesia

April 4, 2025 updated by: Sanliurfa Education and Research Hospital

V-notes (Transluminal Endoscopic Surgery Through Natural Orifices) Hysterectomy With Regional Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Şanlıurfa, Turkey
        • Sanliurfa Education and Research Hospital
      • Şanlıurfa, Turkey, 63250
        • Sanliurfa Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Female patient between the ages of 30-70 Preoperative anesthesia evaluation will be evaluated as ASA 1-2 according to the American Society of Anesthesiologists (ASA) physical status Patients who are given a hysterectomy indication due to uterus, cervix and/or adnexal condition and will undergo V-NOTES will be included in the study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: regional anesthesia
hysterectomy will be done by V-NOTES under regional anesthesia .
Procedure: hysterectomy by V-NOTES
V-notes is like laparoscopy via the vaginal route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: postoperative first 24 hours
vas score
postoperative first 24 hours
complications
Time Frame: postoperative first 24 hours
bleeding, transfusion
postoperative first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Education and Research Hospital

Investigators

  • Study Director: alev esercan, MD, Sanliurfa Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Seah-2-63

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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