RecruitingNot ApplicableNCT05971875

RCT on 3 Types of Hysterectomy

A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.


Sponsor

Dr Jan Baekelandt, MD

Enrollment

1,000 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is a randomized controlled trial comparing three different surgical techniques for performing a hysterectomy (removal of the uterus) for non-cancerous (benign) reasons. The three approaches being compared are robotic-assisted surgery, laparoscopic (keyhole) surgery, and vaginal surgery. The study aims to help surgeons and patients understand which approach is safest, most effective, and results in the best recovery. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have a benign (non-cancerous) condition requiring a hysterectomy - You have given written informed consent before surgery **You may NOT be eligible if...** - You need a hysterectomy as part of treatment for pelvic organ prolapse (Stage II or higher) - Your hysterectomy is indicated due to suspected endometriosis - You need only a partial (subtotal) hysterectomy - You have had previous rectal surgery - Cancer is suspected - You have significant pelvic scarring from past infection (PID) - You have an active genital tract infection - You are pregnant - You have other serious health conditions requiring inpatient care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREvNOTES vs Vaginal Hysterectomy

Comparison of vNOTES vs VH

PROCEDUREvNOTES vs Laparoscopic Hysterectomy

Comparison of vNOTES vs LH


Locations(2)

Dept of Obstetrics and Gynecology

Zadar, Croatia

Dept of Obstetrics and Gynecology

Helsingborg, Sweden

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NCT05971875


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