Trials / Unknown
UnknownNCT01347021
Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV
Sacrospinous Colpopexy Versus High Uterosacral Colpopexy in the Treatment of Genital Prolapse Grade III/IV in Women With Uterus
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- Female
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Uterovaginal Prolapse
- Prolapse of Vaginal Vault After Hysterectomy
- Complete Tear, Sacrospinous Ligament
- Uterosacral Ligament; Rupture
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | sacrospinous 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. |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2009-12-01
- Completion
- 2011-05-01
- First posted
- 2011-05-04
- Last updated
- 2011-05-04
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01347021. Inclusion in this directory is not an endorsement.