Trials / Unknown
UnknownNCT05971875
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.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- Dr Jan Baekelandt, MD · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | vNOTES vs Vaginal Hysterectomy | Comparison of vNOTES vs VH |
| PROCEDURE | vNOTES vs Laparoscopic Hysterectomy | Comparison of vNOTES vs LH |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2023-08-02
- Last updated
- 2024-03-22
Locations
2 sites across 2 countries: Croatia, Sweden
Source: ClinicalTrials.gov record NCT05971875. Inclusion in this directory is not an endorsement.