NCT06776718

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

December 24, 2024

Last Update Submit

January 13, 2025

Conditions

HysterectomyHysterectomy, Benign Uterine DiseasesHysterectomy, Vaginal

Keywords

vNOTESvaginal hysterectomybenign gynecologysurgical outcomesPain

Outcome Measures

Primary Outcomes (1)

  • the duration of surgery

    İnterval from initial incision to the completion of vaginal cuff closure (minute)

    The time from the beginning to the end of the operation

Secondary Outcomes (4)

  • Hospitalization time

    through study completion, an average of 1 month

  • VAS score

    postoperative 6th and 24 th hour

  • Uterin volume

    through study completion, an average of 1 month

  • Re-admission

    within 1 month after discharge

Study Arms (2)

vNOTES hysterectomy for benign indications

EXPERIMENTAL
Procedure: vNOTES

Vaginal hysterectomy for benign indications

EXPERIMENTAL
Procedure: vaginal hysterectomy

Interventions

vNOTESPROCEDURE

vNOTES for benign hysterectomy

vNOTES hysterectomy for benign indications
vaginal hysterectomyPROCEDURE

vaginal hysterectomy for benign hysterectomy

Vaginal hysterectomy for benign indications

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lütfi Kirdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

Related Publications (4)

  • Yildiz P, Keles E, Yildiz G, Birol Ilter P, Temocin RB, Kaya C, Mat E. Health-related quality of life following hysterectomy by vNOTES versus conventional laparoscopy. Minim Invasive Ther Allied Technol. 2024 Aug;33(4):232-236. doi: 10.1080/13645706.2024.2323100. Epub 2024 Mar 4.

    PMID: 39084252BACKGROUND

  • Merlier M, Collinet P, Pierache A, Vandendriessche D, Delporte V, Rubod C, Cosson M, Giraudet G. Is V-NOTES Hysterectomy as Safe and Feasible as Outpatient Surgery Compared with Vaginal Hysterectomy? J Minim Invasive Gynecol. 2022 May;29(5):665-672. doi: 10.1016/j.jmig.2022.01.007. Epub 2022 Jan 21.

    PMID: 35074513BACKGROUND

  • Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.

    PMID: 30325565BACKGROUND

  • Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.

    PMID: 37642285BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Hysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HysterectomyGynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Gazi Yıldız, Assoc Prof

CONTACT

+905535288666drgaziyildiz@gmail.com

Mehmet Mete Kırlangıç, Assoc Prof

CONTACT

+905064641819metekirlangic@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 15, 2025

Study Start

January 1, 2025

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations

TU(1)