Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).

Quality of Life Clinical Trial

— PeSuLife  

Official title:

Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919123
• Other study ID #: 2018-A02927-48
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: October 2022

Study information

• Verified date: April 2019
• Source: University Hospital, Caen
• Contact: Estelle Jamard, Doctor
• Phone: +33 6 88 32 32 11
• Email: estelle.jamard[@]hotmail.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Quality of Life
• Satisfaction
• Symptoms

Intervention

Other:
• Evaluation of laparoscopic promontofixation
Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

Locations

Country	Name	City	State
France	University Hospital	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):609-16. doi: 10.1097/AOG.0b013e3181985312. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. French. — View Citation

Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizée 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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Sexual impact of laparoscopic promontofixation	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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