Vaginal Prolapse
Conditions
Brief 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.
Interventions
PROCEDUREVNOTES/VH
same as above
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* women with vaginal prolapse * capable of having a surgery - assessed by an anesthesiologist * women who approve of having the surgery
Exclusion criteria
* BMI over 40 * women who have recurrent PID (pelvic inflammatory disease) * women with oncology records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| surgery time | from admission up to 6 hours post operation | time of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bleeding | from admission up to 6 hours post operation | bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation. |
| hospital days | from admission up to 96 hours post operation | how many days after surgery for hospitalization |
| PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire | from admission up to 6 hours post operation | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is a scoring index used to measure sexual function of women affected by pelvic organ prolapse. range 0-48. 0 marks good sexual function and 48 measures sexual disability affected from pelvic organ prolapse |
| PFDI score - Pelvic Floor Disability Index | from admission up to 6 hours post operation | The Pelvic Floor Disability Index is an index used to obtain an objective score regarding pelvic floor disability comprising of bowel, bladder, or pelvic symptoms over the last 3 months prior to answering the questionnaire. score ranges 0-300. 0 outcome is no pelvic floor disability and 300 marks a high level of pelvic floor disability. |
Contacts
Primary ContactOmer Mor, mD
Outcome results
None listed