Comparing three methods of hysterectomy for women with benign conditions
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.
This study is testing which of three different surgery methods for hysterectomy works best for women with non-cancerous conditions to help them recover faster and have better results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Imelda Hospital, Bonheiden Academic / other |
| Locations | 2 sites (Zadar and 1 other locations) |
| Trial ID | NCT05971875 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares three different surgical approaches for performing hysterectomies in women aged 18 to 75 with benign gynecological diseases. The study will include 1000 participants and will evaluate the effectiveness and outcomes of vaginal hysterectomy, vaginal natural orifice transluminal surgery (vNOTES), and laparoscopic hysterectomy. The trial aims to determine which method offers the best results in terms of recovery and surgical success.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 75 who require a hysterectomy for benign gynecological conditions.
Not a fit: Patients with stage II+ prolapse, suspected malignancies, or those requiring in-patient care due to other co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with more effective and less invasive options for hysterectomy, leading to improved recovery times and outcomes.
How similar studies have performed: Other studies have shown promising results with minimally invasive surgical approaches, suggesting that this trial's comparative analysis could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy Exclusion Criteria: * Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse repair * hysterectomy due to suspected endometriosis * subtotal hysterectomy * history of rectal surgery * suspected malignancy * suspected obliteration of the pouch of Douglas following severe PID or other causes * active lower genital tract infection * pregnancy * failure to provide written informed consent prior to surgery * requirement of in-patient care due to other co-morbidities
Where this trial is running
Zadar and 1 other locations
- Dept of Obstetrics and Gynecology — Zadar, Croatia (Recruiting)
- Dept of Obstetrics and Gynecology — Helsingborg, Sweden (Recruiting)
Study contacts
- Principal investigator: JAn Baekelandt — Imeldaziekenhuis
- Study coordinator: Jan Baekelandt, Prof
- Email: jan.baekelandt@imelda.be
- Phone: 0032499471371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.