Clinical trial NCT04270188: Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues
Official title: Prospective Study of the Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: middle anterior prolapse ≥ II (POP-Q classification)
anterior prolapse ≥ II (POP-Q classification)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 18 years old with middle and / or anterior prolapse ≥ II in the POP-Q classification and for whom an intervention by anterior sacrospinofixation by autologous tissues is planned.

Brief summary: Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue.

Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study.

The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.


Eligibility criteria: Inclusion Criteria:

* women over 18
* middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring surgical correction of stage ≥ II in the POP-Q classification
* patients wanting an intervention because of the discomfort caused by the prolapse
* intervention planned by anterior sacrospinofixation by autologous tissues
* person having expressed his non-opposition

Exclusion Criteria:

* prolapse of stage \< II in the POP-Q classification, or prolapse without functional impairment
* disorders involving an unacceptable risk of postoperative complications sought after questioning of the patient (blood coagulation disorders, immune system disorders, progressive diseases, etc.)
* reduced mobility of the lower limbs (not allowing positioning for surgery)
* pregnancy or any pregnancy plan for the duration of the study
* active or latent infection
* inability to understand the information given
* person deprived of liberty, under guardianship.

Primary outcomes:
measure: improvement of symptoms
timeFrame: at Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Géry LAMBLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: