Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Female Genital Prolapse. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to determine the rate of recurrence of central pelvic organ prolapse in patients who have undergone surgery (sacropexy with and without mesh) for the same pathology.
Detailed description
There is a lack of data in the literature comparing sacroplexing with the use of mesh with sacroplexing performed without the use of mesh in terms of recurrence, improvement in symptoms, and restoration of normal pelvic organ prolapse relationships. The objective of this study is to determine the rate of recurrence of central pelvic organ prolapse in patients with a clinical diagnosis of genital prolapse stage ≥ 2 according to the POP-Q classification who underwent laparoscopic sacroplasty with mesh (group 1) and without mesh (group 2). The study may provide information on the impact of mesh in laparoscopic surgery for the correction of central pelvic organ prolapse.
Primary outcome measures
- Recurrence rate of central pelvic organ prolapse [Time frame: 24 months after surgery]
Secondary outcome measures (4)
- Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy [Time frame: 24 months after surgery]
- Rate of intraoperative and postoperative complications [Time frame: During surgery and within 30 days]
- Modification of symptoms after surgery [Time frame: Before surgery and 24 months after surgery]
- Changes in the disease framework [Time frame: Before surgery and 24 months after surgery]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Clinical diagnosis of genital prolapse stage ≥ 2 according to POP-Q classification
- Surgical treatment of laparoscopic sacropexy by mesh (group 1) and without (group 2) in female patients
- Acquisition of informed consent
- At least one follow-up evaluation at 24 months
Exclusion criteria
- Age > 80 years
- Previous genital prolapse surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
- Azienda Ospedaliera Universitaria Integrata di Verona — Verona
Identifiers
NCT: NCT06720831 · SACROMESH