Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues (SANTAU)

February 28, 2024 updated by: Hospices Civils de Lyon

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

Active, not recruiting

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bron, France, 69500
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Estimated)

July 11, 2025

Study Completion (Estimated)

July 11, 2025

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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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