Complete Tear, Sacrospinous Ligament, Prolapse of Vaginal Vault After Hysterectomy, Uterosacral Ligament; Rupture, Uterovaginal Prolapse
Conditions
Keywords
vaginal colpopexy sacrospinous, vaginal colpopexy uterosacral
Brief summary
The purpose of this study is to compare the vaginal sacrospinous colpopexy and high uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.
Detailed description
Hysterectomy is often the traditional approach for women with uterovaginal prolapse. However, hysterectomy alone does not address the underlying problem of deficient apical support. Surgical options for patients with apical prolapse include transvaginal suspension procedures using pelvic structures for fixation, such as the sacrospinous ligament or uterosacral ligaments.The objective of this study is to compare the sacrospinous fixation with high uterosacral in the treatment of uterine prolapse POP-Q stage 3 or 4 in terms of recurrence of prolapse,quality of life,complications,post-operative recovery, hospital stay.
Interventions
PROCEDUREsacrospinous colpopexy versus high uterosacral colpopexy
Women with uterine prolapse grade III or IV were randomly allocated to the sacrospinous colpopexy or high uterosacral colpopexy with vaginal hysterectomy.Before the surgery P-Qol questionnaire were completed and urogynecological examination include de POP-Q system was done. All patients underwent clinical check-ups 1, 6 and 12 months postoperatively. Each check-up included clinical examination and questionnaire.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* pelvic prolapse III/IV * counselling and informed consent
Exclusion criteria
* abnormal cervical smears * abnormal ultrasound findings of uterus or ovaries or abnormal uterine bleeding * pelvic radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up | one year | Quantification of pelvic organ prolapse, according to the Pelvic Organ Prolapse Quantification system (POPQ), as standardized by the International Continence Society. |
Secondary
| Measure | Time frame |
|---|---|
| subjective improvement in quality of life measured by Quality-of-Life Questionnaire (P-QoL)after surgery at 12 months follow-up | one year |
Countries
Brazil
Outcome results
None listed