An observational study in Female Genital Prolapse, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 2 sites in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's planned enrollment of 160 is close to the median of 150 across 27 observational studies indexed under Prolapse.
Browse Prolapse studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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Patients diagnosed with genital prolapse stage ≥ 2 according to the POP-Q classification undergoing laparoscopic sacroplexxy with mesh and laparoscopic sacropexy without mesh
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recurrence rate of central pelvic organ prolapse
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, undergoing sacroplasty with and without mesh
Time frame: 24 months after surgery
Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy
The rate of pelvic organ prolapse recurrence in patients treated with mesh (group 1) and without (group 2) in the laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy
Time frame: 24 months after surgery
Rate of intraoperative and postoperative complications
Evaluation of intraoperative and postoperative complications according to the Clavien-Dindo classification
Time frame: During surgery and within 30 days
Modification of symptoms after surgery
Change in pre- and post-operative symptomatology assessed through the completion of a questionnaire
Time frame: Before surgery and 24 months after surgery
Changes in the disease framework
Change in the disease framework of pelvic organ prolapse according to the POP-Q classification assessed before and after surgery
Time frame: Before surgery and 24 months after surgery
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