Clinical trial NCT03919123: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Symptoms
Satisfaction
Quality of Life
Keywords: Pelvic Organ Prolapse
laparoscopic promontofixation
symptoms
Satisfaction
Quality of Life
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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)

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

Primary outcomes:
measure: Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms
timeFrame: 3 years
Secondary outcomes:
measure: Effect of laparoscopic promontofixation on urinary incontinence
timeFrame: 3 years
measure: Sexual impact of laparoscopic promontofixation
timeFrame: 3 years
measure: Evaluation of quality of life after prolapse surgery
timeFrame: 3 years
measure: Assessment of patient satisfaction after surgery
timeFrame: 3 years
measure: Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications
timeFrame: 3 years
measure: Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone)
timeFrame: 3 years
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
state: Normandie
Study officials:
affiliation: Universitary hospital of Caen
name: Anne-Cécile Pizzoferrato, MD, PhD
role: STUDY_DIRECTOR
References:
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