VNOTES and Vaginal Hysterectomy for Benign Indications

NCT ID: NCT06776718

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hysterectomy Hysterectomy, Benign Uterine Diseases Hysterectomy, Vaginal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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vNOTES hysterectomy for benign indications

Group Type EXPERIMENTAL

vNOTES

Intervention Type PROCEDURE

vNOTES for benign hysterectomy

Vaginal hysterectomy for benign indications

Group Type EXPERIMENTAL

vaginal hysterectomy

Intervention Type PROCEDURE

vaginal hysterectomy for benign hysterectomy

Interventions

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vNOTES

vNOTES for benign hysterectomy

Intervention Type PROCEDURE

vaginal hysterectomy

vaginal hysterectomy for benign hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Mete Kırlangıç

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kartal Dr Lütfi Kirdar City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gazi Yıldız, Assoc Prof

Role: CONTACT

+905535288666

Mehmet Mete Kırlangıç, Assoc Prof

Role: CONTACT

+905064641819

Facility Contacts

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Kartal Dr. Lütfi Kırdar Şehir Hastanesi

Role: primary

+902164413900

Gazi Yıldız, Assoc Prof

Role: backup

Pınar Yıldız, MD

Role: backup

Esra Keleş, Assoc Prof

Role: backup

Pınar Birol İlter, MD

Role: backup

Kasım Turan, MD

Role: backup

Emre Mat, Assoc Prof

Role: backup

Mehmet Mete Kırlangıç, Assoc Prof

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 39084252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35074513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30325565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37642285 (View on PubMed)

Other Identifiers

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2021/514/214/25

Identifier Type: -

Identifier Source: org_study_id

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