- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270188
Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues (SANTAU)
Prospective Study of the Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Géry LAMBLIN, MD
- Phone Number: +33 472 35 58 71
- Email: gery.lamblin@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69500
- Hospices Civils de Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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.
|
evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement of symptoms
Time Frame: at Month 2
|
percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3)
|
at Month 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Géry LAMBLIN, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0077
- 2020-A00350-39 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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