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Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity.
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)
This is a retrospective cohort study conducted at the Universitary hospital of Caen in three surgical departments (gynecology, urology and digestive surgery).
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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of laparoscopic promontofixation | Other | Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms | The main objective is to collect the PFDI-20 score after the surgery. This score was developped to evaluate the genital, anorectal and digestive symptoms related to prolapse | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of laparoscopic promontofixation on urinary incontinence | Assessment of the ICIQ-SF score, a specific score developped to assess the impact urinary incontinence | 3 years |
| Sexual impact of laparoscopic promontofixation |
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Inclusion Criteria:
Patients who have had a laparoscopic promotofixation for genital prolapse at the University Hospital of Caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery.
Patient who received written information and agreed to participate in the study
Exclusion Criteria:
Minor patient, under guardianship, under trusteeship Patient not understanding French Refusal to participate in the study
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Patient over 18 years old who underwent a laparoscopic promontofixation for pelvic organ prolapse at the University Hospital of Caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery, and agreed to participate in the study after a written information
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Estelle Jamard, Doctor | Contact | +33 6 88 32 32 11 | estelle.jamard@hotmail.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Cécile Pizzoferrato, MD, PhD | Universitary hospital of Caen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Caen | Normandy | 14 000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19300324 | Background | 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. | |
| 19969258 | Background | 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. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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Evaluation of the PISQ-12 score after laparoscopic promontofixation. This score was developped specifically to evaluate sexual troubles in case of genital prolapse
| 3 years |
| Evaluation of quality of life after prolapse surgery | Evaluation of the quality of life using a score specifically developped in case of genital prolapse : the PFIQ-7 score | 3 years |
| Assessment of patient satisfaction after surgery | Evaluation of the quality of life using the PGI-I score, developped to quantify the effect of urinary or prolapse treatments | 3 years |
| Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications | Evaluation of the PFDI-20 score in women undergoing laparoscopic rectopexy | 3 years |
| Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone) | Comparison of the PFDI-20 scores according to the operative indication | 3 years |
| 24875570 | Background | 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. |
| 28506877 | Background | 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. |
| 23633316 | Background | 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. |
| 21306698 | Background | 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. |
| 29472143 | Background | 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. |
| 15902189 | Background | 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. |
| 17867956 | Background | 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. |
| 19201521 | Background | 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. |
| 27052819 | Background | 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. |
| 19353330 | Background | 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. |
| 19762041 | Background | 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. |
| 16230128 | Background | 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. |
| 21353736 | Background | 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. |
| 15082210 | Background | 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. |
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