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The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.
Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.
Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterosacral ligaments suspension | Experimental | Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments. |
|
| McCall culdoplasty | Active Comparator | Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal vault suspension to the uterosacral ligaments | Procedure | Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Vaginal vault prolapse | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary impact questionnaire score (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life. | 12 months after surgery |
| Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Simone Laganà, M.D. | Contact | 3296279579 | +39 | antoniosimone.lagana@asst-settelaghi.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Simone Laganà, M.D. | Università degli Studi dell'Insubria | Principal Investigator |
| Jvan Casarin, M.D. | Università degli Studi dell'Insubria | Principal Investigator |
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Prospective Randomized Clinical trial
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| McCall culdoplasty | Procedure | Vaginal hysterectomy with McCall culdoplasty |
|
A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life. |
| 12 months after surgery |
| Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of prolapse-related colorectal and anal symptoms and signs on the quality of life. | 12 months after surgery |
| Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48) | A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions. | 12 months after surgery |
| Antonella Cromi, M.D., Ph.D. |
| Università degli Studi dell'Insubria |
| Study Chair |
| Fabio Ghezzi, M.D. | Università degli Studi dell'Insubria | Study Director |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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