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Search / Trial NCT04270188

Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues

Launched by HOSPICES CIVILS DE LYON · Feb 12, 2020

Trial Information

Current as of May 01, 2025

Active, not recruiting

Keywords

Middle Anterior Prolapse ≥ Ii (Pop Q Classification) Anterior Prolapse ≥ Ii (Pop Q Classification)

ClinConnect Summary

This clinical trial is studying a surgical technique called anterior sacrospinofixation, which uses the patient's own tissues to treat pelvic organ prolapse—a condition that can cause discomfort and affect daily life. Many women experience problems with their pelvic, urinary, or sexual health due to this condition. While traditional treatments often involve implants, this trial is exploring a method that avoids them, focusing on improving the symptoms of women suffering from mid-level or anterior genital prolapse.

To participate in the trial, women must be over 18 years old and have a specific type of prolapse that requires surgery. They should be experiencing discomfort from their condition and be willing to undergo the surgery. Participants can expect to be closely monitored after the procedure to evaluate how their symptoms change. It's important to note that the trial is currently active but not recruiting new participants, and it has certain exclusions, such as active infections or serious health issues that could complicate surgery.

Gender

FEMALE

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.

About Hospices Civils De Lyon

Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.

Locations

Bron, , France

Patients applied

0 patients applied

Trial Officials

Géry LAMBLIN, MD

Principal Investigator

Hospices Civils de Lyon

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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