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NCT Number: NCT06776718

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.

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Key information

Conditions

Hysterectomy Hysterectomy, Benign Uterine Diseases Hysterectomy, Vaginal Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr Lütfi Kirdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Location contact

Emre Mat, Assoc Prof

CONTACT

Esra Keleş, Assoc Prof

CONTACT

Gazi Yıldız, Assoc Prof

CONTACT

Kartal Dr. Lütfi Kırdar Şehir Hastanesi

CONTACT

[email protected]

+902164413900

Kasım Turan, MD

CONTACT

Mehmet Mete Kırlangıç, Assoc Prof

CONTACT

Pınar Birol İlter, MD

CONTACT

Pınar Yıldız, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vNOTES

Procedure

vNOTES for benign hysterectomy

Vaginal hysterectomy

Procedure

vaginal hysterectomy for benign hysterectomy

Primary outcomes

  1. 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)

Secondary outcomes

  1. Hospitalization time

    Time frame: through study completion, an average of 1 month

    Time from surgery to discharge (hours)

  2. VAS score

    Time frame: postoperative 6th and 24 th hour

    Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)

  3. 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

  4. Re-admission

    Time frame: within 1 month after discharge

    Re-admission to hospital after discharge (yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Gazi Yıldız, Assoc Prof

CONTACT

[email protected]

+905535288666

Mehmet Mete Kırlangıç, Assoc Prof

CONTACT

[email protected]

+905064641819

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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