Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV
This study is enrolling participants by invitation only.
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01347021
First received: April 25, 2011
Last updated: May 3, 2011
Last verified: May 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterovaginal Prolapse Prolapse of Vaginal Vault After Hysterectomy Complete Tear, Sacrospinous Ligament Uterosacral Ligament; Rupture |
Procedure: sacrospinous colpopexy versus high uterosacral colpopexy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sacrospinous Colpopexy Versus High Uterosacral Colpopexy in the Treatment of Genital Prolapse Grade III/IV in Women With Uterus |
Resource links provided by NLM:
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Pelvic Organ Prolapse Quantification (POPQ) at 12 months follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]Quantification of pelvic organ prolapse, according to the Pelvic Organ Prolapse Quantification system (POPQ), as standardized by the International Continence Society.
Secondary Outcome Measures:
- subjective improvement in quality of life measured by Quality-of-Life Questionnaire (P-QoL)after surgery at 12 months follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2011 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: sacrospinous, pelvic prolapse.
Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
|
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.
Other Names:
|
|
Active Comparator: uterosacral , pelvic prolapse.
Women with pelvic prolapse grade III/IV were randomly allocated to the sacrospinous colpopexy (25 women) or high uterosacral (26 women)
|
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.
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347021
Locations
| Brazil | |
| Federal University of São Paulo | |
| São Paulo, Brazil, 04023062 | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Study Chair: | Manoel C B Girão, MD | Federal University of São Paulo |
| Principal Investigator: | Sergio B Martins, md | Federal University of São Paulo |
More Information
Additional Information:
Publications:
| Responsible Party: | sergio brasileiro martins md, unifesp- gynecology session |
| ClinicalTrials.gov Identifier: | NCT01347021 History of Changes |
| Other Study ID Numbers: | unifespcep0833/05 |
| Study First Received: | April 25, 2011 |
| Last Updated: | May 3, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
vaginal colpopexy sacrospinous vaginal colpopexy uterosacral |
Additional relevant MeSH terms:
|
Prolapse Uterine Prolapse Rupture Pathological Conditions, Anatomical |
Uterine Diseases Genital Diseases, Female Pelvic Organ Prolapse Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013