VNOTES and Vaginal Hysterectomy for Benign Indications

Not Applicable

Not yet recruiting

• Conditions: Hysterectomy; Hysterectomy, Benign Uterine Diseases; Hysterectomy, Vaginal

• Registration Number: NCT06776718
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-24
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the duration of surgery	The time from the beginning to the end of the operation	İnterval from initial incision to the completion of vaginal cuff closure (minute)

Secondary Outcome Measures

Name	Time	Method
Hospitalization time	through study completion, an average of 1 month	Time from surgery to discharge (hours)
VAS score	postoperative 6th and 24 th hour	Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)
Uterin volume	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
Re-admission	within 1 month after discharge	Re-admission to hospital after discharge (yes/no)

Trial Locations

Locations (1)

Kartal Dr Lütfi Kirdar City Hospital; 🇹🇷 İstanbul, Turkey