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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNOTES ARM | Experimental | treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments. |
|
| Vaginal hysterectomy Arm | Experimental | treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNOTES/VH | Procedure | same as above |
|
| Measure | Description | Time Frame |
|---|---|---|
| surgery time | time of surgery | from admission up to 6 hours post operation |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding | bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation. | from admission up to 6 hours post operation |
| hospital days | how many days after surgery for hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
only women suffer from vaginal prolapse
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omer Mor, mD | Contact | 972546486414 | omermor23@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Omer Mor, MD | Rambam Health Care Campus | Principal Investigator |
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| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| from admission up to 96 hours post operation |
| PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire | 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 | from admission up to 6 hours post operation |
| PFDI score - Pelvic Floor Disability Index | 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. | from admission up to 6 hours post operation |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |