SIS Graft and Traditional Repair in Vaginal Wall Prolapse
NCT ID: NCT00827528
Last Updated: 2012-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2006-08-31
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transperineal Repair of Primary Obstetric Rectovaginal Fistulas
NCT04267757
Anterior Prolapse Repair With and Without Graft Augmentation
NCT04085952
Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT
NCT02808377
Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome
NCT01911884
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
NCT01257659
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SIS graft
this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
Biologic Graft (SIS)
Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
2
this group will use a traditional repair on correction of anterior vaginal wall prolapse.
Traditional correction of anterior vaginal wall prolapse
Traditional repair.
Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Traditional correction of anterior vaginal wall prolapse
Traditional repair.
Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
Biologic Graft (SIS)
Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* pre and postmenopausal patients
Exclusion Criteria
* infection;
* coagulopathy;
* gynecologic cancer;
* liver or kidney active diseases.
30 Years
85 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paulo Cezar Feldner Jr
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Manoel João BC Girão, PhD
Role: STUDY_CHAIR
Department of Gynecology, Federal University of São Paulo
Paulo C Feldner Jr, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecology, Federal University of São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal University of São Paulo
São Paulo, São Paulo/SP, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J, Abed H, Wheeler TL 2nd, Morrill MY, Clemons JL, Rahn DD, Lukban JC, Lowenstein L, Kenton K, Young SB; Society of Gynecologic Surgeons Systematic Review Group. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol. 2008 Nov;112(5):1131-42. doi: 10.1097/AOG.0b013e3181898ba9.
Bako A, Dhar R. Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):103-11. doi: 10.1007/s00192-008-0717-5. Epub 2008 Sep 9.
Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, Burr J. Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. BJOG. 2008 Oct;115(11):1350-61. doi: 10.1111/j.1471-0528.2008.01845.x. Epub 2008 Aug 19.
Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn. 2008;27(1):3-12. doi: 10.1002/nau.20542.
Chen CC, Ridgeway B, Paraiso MF. Biologic grafts and synthetic meshes in pelvic reconstructive surgery. Clin Obstet Gynecol. 2007 Jun;50(2):383-411. doi: 10.1097/GRF.0b013e31804b184c.
Silva WA, Karram MM. Scientific basis for use of grafts during vaginal reconstructive procedures. Curr Opin Obstet Gynecol. 2005 Oct;17(5):519-29. doi: 10.1097/01.gco.0000180156.64879.00.
Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004014. doi: 10.1002/14651858.CD004014.pub3.
Maher C, Baessler K. Surgical management of anterior vaginal wall prolapse: an evidencebased literature review. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):195-201. doi: 10.1007/s00192-005-1296-3. Epub 2005 May 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SISAPI 01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.