Trials / Unknown
UnknownNCT04078802
0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Rambam Health Care Campus · Academic / Other
- Sex
- Female
- Age
- 25 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.
Detailed description
The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | VNOTES/VH | same as above |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2020-10-01
- Completion
- 2020-11-01
- First posted
- 2019-09-06
- Last updated
- 2019-09-09
Source: ClinicalTrials.gov record NCT04078802. Inclusion in this directory is not an endorsement.