Study Results
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View full resultsBasic Information
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COMPLETED
272 participants
OBSERVATIONAL
2017-05-01
2017-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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pelvic organ prolapse repair
Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.
Eligibility Criteria
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Inclusion Criteria
* woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
* informed and not opposed to the use of her data
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Coloplast A/S
INDUSTRY
Groupe Hospitalier de la Rochelle Ré Aunis
OTHER
Responsible Party
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Principal Investigators
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Philippe Ferry, MD
Role: STUDY_DIRECTOR
Groupe Hospitalier de la Rochelle Ré Aunis
Locations
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CH Dunkerque
Grande-Synthe, , France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, , France
Clinique Saint Ame
Lambres-lez-Douai, , France
CH de Laon
Laon, , France
Clinique Jules Verne
Nantes, , France
CHU Nîmes
Nîmes, , France
Hôpital des Diaconesses
Paris, , France
Hôpital Kremlin-Bicêtre
Paris, , France
CH de Cornouaille
Quimper, , France
Clinique St Michel et St Anne
Quimper, , France
Polyclinique de Courlancy
Reims, , France
Clinique la Sagesse
Rennes, , France
CH Robert Pax
Sarreguemines, , France
Agyl
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Hôpitaux du Léman
Thonon-les-Bains, , France
Countries
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References
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Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. French.
Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.
Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. French.
Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079.
Ferry P, Bertherat P, Gauthier A, Villet R, Del Piano F, Hamid D, Fernandez H, Broux PL, Salet-Lizee D, Vincens E, Ntshaykolo P, Debodinance P, Pocholle P, Thirouard Y, de Tayrac R. Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle(R) Direct Fix. A retrospective study on feasibility and morbidity. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):443-449. doi: 10.1016/j.jogoh.2018.06.001. Epub 2018 Jun 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Association Française de Normalisation (AFNOR). Norme Française (NF) S 94-801 implants de renfort mis en place par voie vaginale pour cure d'incontinence urinaire d'effort et/ou de prolapsus des organes pelviens. Essais pré-cliniques et essais cliniques
Other Identifiers
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2016/P05/179
Identifier Type: -
Identifier Source: org_study_id
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