Pelvic Organ Prolapse
Conditions
Keywords
Laparoscopy, Hysterectomy, Uterosacral ligaments suspension, McCall culdoplasty, Post-hysterectomy vault prolapse
Brief summary
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.
Interventions
PROCEDUREVaginal vault suspension to the uterosacral ligaments
Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
PROCEDUREMcCall culdoplasty
Vaginal hysterectomy with McCall culdoplasty
Sponsors
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective Randomized Clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Stage II-III pelvic organ prolapse * Bilateral preservation of the ovaries * Sexually active women
Exclusion criteria
* Smoking * Body Mass Index \> 30 * Strenuous activity (frequent heavy lifting) * Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities * Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 12 months after surgery | Vaginal vault prolapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary impact questionnaire score (total score minimum: 0, maximum: 100) | 12 months after surgery | A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life. |
| Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100) | 12 months after surgery | A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life. |
| Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100) | 12 months after surgery | A specific questionnaire developed to investigate the impact of prolapse-related colorectal and anal symptoms and signs on the quality of life. |
| Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48) | 12 months after surgery | A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions. |
Contacts
Primary ContactAntonio Simone Laganà, M.D.
Outcome results
None listed