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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

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)


Condition or disease Intervention/treatment
Pelvic Organ Prolapse Symptoms Satisfaction Quality of Life Other: Evaluation of laparoscopic promontofixation

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)


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : October 2022

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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919123


Contacts
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Contact: Estelle Jamard, Doctor +33 6 88 32 32 11 estelle.jamard@hotmail.fr

Locations
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France
University Hospital Recruiting
Caen, Normandie, France, 14 000
Contact: Estelle Jamard, Doctor    +33 6 88 32 32 11    estelle.jamard@hotmail.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Study Director: Anne-Cécile Pizzoferrato, MD, PhD Universitary hospital of Caen

Publications:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03919123     History of Changes
Other Study ID Numbers: 2018-A02927-48
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Caen:
Pelvic Organ Prolapse
laparoscopic promontofixation
symptoms
Satisfaction
Quality of Life

Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical