SANTAU: Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04270188

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: evolution of patient symptoms

Study Design

Study Type:

Observational

Anticipated Enrollment :

66 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prospective Study of the Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Actual Study Start Date :

Jul 21, 2020

Anticipated Primary Completion Date :

Sep 21, 2025

Anticipated Study Completion Date :

Sep 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
anterior sacrospinofixation with autologous tissue patients 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.	Other: evolution of patient symptoms evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery

Arm

Intervention/Treatment

anterior sacrospinofixation with autologous tissue

patients 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.

Other: evolution of patient symptoms

evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery

Outcome Measures

Primary Outcome Measures

improvement of symptoms [at Month 2]
percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Géry LAMBLIN, MD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04270188

Other Study ID Numbers:

69HCL20_0077
2020-A00350-39

First Posted:

Feb 17, 2020

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

middle anterior prolapse ≥ II (POP-Q classification)

anterior prolapse ≥ II (POP-Q classification)

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of May 17, 2022