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VNOTES and Vaginal Hysterectomy for Benign Indications

Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06776718
Enrollment
100
Registered
2025-01-15
Start date
2025-01-31
Completion date
2025-02-28
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy, Hysterectomy, Benign Uterine Diseases, Hysterectomy, Vaginal

Keywords

vNOTES, vaginal hysterectomy, benign gynecology, surgical outcomes, Pain

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.

Interventions

PROCEDUREvNOTES

vNOTES for benign hysterectomy

PROCEDUREvaginal hysterectomy

vaginal hysterectomy for benign hysterectomy

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the duration of surgeryThe time from the beginning to the end of the operationİnterval from initial incision to the completion of vaginal cuff closure (minute)

Secondary

MeasureTime frameDescription
Hospitalization timethrough study completion, an average of 1 monthTime from surgery to discharge (hours)
VAS scorepostoperative 6th and 24 th hourVisual Analog Score for pain at postoperative 6th and 24 th hour (0-10)
Uterin volumethrough study completion, an average of 1 monthUterine 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
Re-admissionwithin 1 month after dischargeRe-admission to hospital after discharge (yes/no)

Countries

Turkey (Türkiye)

Contacts

Primary ContactGazi Yıldız, Assoc Prof
drgaziyildiz@gmail.com+905535288666
Backup ContactMehmet Mete Kırlangıç, Assoc Prof
metekirlangic@gmail.com+905064641819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026