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Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL). (PeSuLife)

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ClinicalTrials.gov Identifier: NCT03919123
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date April 15, 2019
First Posted Date April 18, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2019)
Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms [ Time Frame: 3 years ]
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 17, 2019)
  • Effect of laparoscopic promontofixation on urinary incontinence [ Time Frame: 3 years ]
    Assessment of the ICIQ-SF score, a specific score developped to assess the impact urinary incontinence
  • Sexual impact of laparoscopic promontofixation [ Time Frame: 3 years ]
    Evaluation of the PISQ-12 score after laparoscopic promontofixation. This score was developped specifically to evaluate sexual troubles in case of genital prolapse
  • Evaluation of quality of life after prolapse surgery [ Time Frame: 3 years ]
    Evaluation of the quality of life using a score specifically developped in case of genital prolapse : the PFIQ-7 score
  • Assessment of patient satisfaction after surgery [ Time Frame: 3 years ]
    Evaluation of the quality of life using the PGI-I score, developped to quantify the effect of urinary or prolapse treatments
  • Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications [ Time Frame: 3 years ]
    Evaluation of the PFDI-20 score in women undergoing laparoscopic rectopexy
  • Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone) [ Time Frame: 3 years ]
    Comparison of the PFDI-20 scores according to the operative indication
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).
Official Title Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
Brief 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)

Detailed 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)

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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
Condition
  • Pelvic Organ Prolapse
  • Symptoms
  • Satisfaction
  • Quality of Life
Intervention Other: Evaluation of laparoscopic promontofixation
Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Estelle Jamard, Doctor +33 6 88 32 32 11 estelle.jamard@hotmail.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03919123
Other Study ID Numbers 2018-A02927-48
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Caen
Study Sponsor University Hospital, Caen
Collaborators Not Provided
Investigators
Study Director: Anne-Cécile Pizzoferrato, MD, PhD Universitary hospital of Caen
PRS Account University Hospital, Caen
Verification Date April 2019