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VNOTES and Vaginal Hysterectomy for Benign Indications

R

Republic of Turkey Ministry of Health

Status

Not yet enrolling

Conditions

Hysterectomy, Vaginal
Hysterectomy, Benign Uterine Diseases
Hysterectomy

Treatments

Procedure: vaginal hysterectomy
Procedure: vNOTES

Study type

Interventional

Funder types

Other

Identifiers

NCT06776718
2021/514/214/25

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

vNOTES hysterectomy for benign indications
Experimental group
Treatment:
Procedure: vNOTES
Vaginal hysterectomy for benign indications
Experimental group
Treatment:
Procedure: vaginal hysterectomy

Trial contacts and locations

1

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Central trial contact

Gazi Yıldız, Assoc Prof; Mehmet Mete Kırlangıç, Assoc Prof

Data sourced from clinicaltrials.gov

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