VNOTES and Vaginal Hysterectomy for Benign Indications

January 13, 2025 updated by: Mehmet Mete Kırlangıç, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications

This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.

A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey, 34865
        • Kartal Dr Lutfi Kirdar City Hospital
        • Contact:
        • Contact:
          • Gazi Yıldız, Assoc Prof
        • Contact:
          • Pınar Yıldız, MD
        • Contact:
          • Esra Keleş, Assoc Prof
        • Contact:
          • Pınar Birol İlter, MD
        • Contact:
          • Kasım Turan, MD
        • Contact:
          • Emre Mat, Assoc Prof
        • Contact:
          • Mehmet Mete Kırlangıç, Assoc Prof

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:

  • aged between 40 and 80 years
  • undergo hysterectomy for benign gynecological conditions

Exclusion Criteria:

  • history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
  • suspected gynecologic malignancies,
  • endometriosis,
  • tubal-ovarian abscesses,
  • pelvic organ prolapse exceeding grade 2,
  • individuals who refused to participate in the study

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vNOTES hysterectomy for benign indications
Procedure: vNOTES
vNOTES for benign hysterectomy
Experimental: Vaginal hysterectomy for benign indications
Procedure: vaginal hysterectomy
vaginal hysterectomy for benign hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the duration of surgery
Time Frame: The time from the beginning to the end of the operation
İnterval from initial incision to the completion of vaginal cuff closure (minute)
The time from the beginning to the end of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization time
Time Frame: through study completion, an average of 1 month
Time from surgery to discharge (hours)
through study completion, an average of 1 month
VAS score
Time Frame: postoperative 6th and 24 th hour
Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)
postoperative 6th and 24 th hour
Uterin volume
Time Frame: through study completion, an average of 1 month
Uterine volume is quantified in milimeters based on measurement of pathological specimens, calculate using the formula (Uterine volume (ml)= (anterior-posterior diameter)* (sagital diameter) * (transverse diameter) * 0,0005236
through study completion, an average of 1 month
Re-admission
Time Frame: within 1 month after discharge
Re-admission to hospital after discharge (yes/no)
within 1 month after discharge

Collaborators and Investigators

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

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/514/214/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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