Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).
NCT ID: NCT03919123
Last Updated: 2019-04-18
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
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UNKNOWN
200 participants
OBSERVATIONAL
2019-01-01
2022-10-31
Brief Summary
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The main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons.
Our team wishes to evaluate, on a cohort of patients operated at the Caen University Hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (POP) repair by Laparoscopic Promontofixation (PFL) through symptoms and quality of life validated questionnaires (QoL).
The analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)
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Detailed Description
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Patients who had a laparoscopic promontofixation will be asked to respond to validated questionnaires of symptoms and quality of life after their surgery (PFDI-20, ICIQ-SF, PFIQ-7) and satisfaction (PGI-I)
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Evaluation of laparoscopic promontofixation
Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
Eligibility Criteria
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Inclusion Criteria
Patient who received written information and agreed to participate in the study
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Principal Investigators
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Anne-Cécile Pizzoferrato, MD, PhD
Role: STUDY_DIRECTOR
Universitary hospital of Caen
Locations
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University Hospital
Caen, Normandy, France
Countries
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Central Contacts
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Facility Contacts
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References
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Fritel X, Varnoux N, Zins M, Breart G, Ringa V. Symptomatic pelvic organ prolapse at midlife, quality of life, and risk factors. Obstet Gynecol. 2009 Mar;113(3):609-616. doi: 10.1097/AOG.0b013e3181985312.
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.
Adjoussou SA, Bohoussou E, Bastide S, Letouzey V, Fatton B, de Tayrac R. [Functional symptoms and associations of women with genital prolapse]. Prog Urol. 2014 Jun;24(8):511-7. doi: 10.1016/j.purol.2013.11.015. Epub 2013 Dec 27. French.
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: Synthesis of the guidelines for the surgical treatment of primary pelvic organ prolapse in women by the AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP. J Gynecol Obstet Hum Reprod. 2017 May;46(5):387-391. doi: 10.1016/j.jogoh.2017.05.001. Epub 2017 May 12. No abstract available.
Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016.
Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizee D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19.
Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.
Hsiao KC, Latchamsetty K, Govier FE, Kozlowski P, Kobashi KC. Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse. J Endourol. 2007 Aug;21(8):926-30. doi: 10.1089/end.2006.0381.
Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4.
Chevrot A, Droupy S, Linares E, de Tayrac R, Costa P, Wagner L. [Impact of laparoscopic sacrocolpopexy on symptoms, health-related quality of life and sexuality: A 3-year prospective study]. Prog Urol. 2016 Sep;26(10):558-65. doi: 10.1016/j.purol.2016.02.009. Epub 2016 Mar 24. French.
Loffeld CJ, Thijs S, Mol BW, Bongers MY, Roovers JP. Laparoscopic sacrocolpopexy: a comparison of Prolene and Tutoplast mesh. Acta Obstet Gynecol Scand. 2009;88(7):826-30. doi: 10.1080/00016340902883158.
Deprest J, De Ridder D, Roovers JP, Werbrouck E, Coremans G, Claerhout F. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol. 2009 Nov;182(5):2362-8. doi: 10.1016/j.juro.2009.07.043. Epub 2009 Sep 16.
Govier FE, Kobashi KC, Kuznetsov DD, Comiter C, Jones P, Dakil SE, James R Jr. Complications of transvaginal silicone-coated polyester synthetic mesh sling. Urology. 2005 Oct;66(4):741-5. doi: 10.1016/j.urology.2005.04.027.
Sergent F, Resch B, Loisel C, Bisson V, Schaal JP, Marpeau L. Mid-term outcome of laparoscopic sacrocolpopexy with anterior and posterior polyester mesh for treatment of genito-urinary prolapse. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):217-22. doi: 10.1016/j.ejogrb.2011.01.022. Epub 2011 Feb 26.
Antiphon P, Elard S, Benyoussef A, Fofana M, Yiou R, Gettman M, Hoznek A, Vordos D, Chopin DK, Abbou CC. Laparoscopic promontory sacral colpopexy: is the posterior, recto-vaginal, mesh mandatory? Eur Urol. 2004 May;45(5):655-61. doi: 10.1016/j.eururo.2004.01.004.
D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23. doi: 10.1007/s00464-005-0485-y.
Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.
Other Identifiers
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2018-A02927-48
Identifier Type: -
Identifier Source: org_study_id
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