Female Genital ProlapseNCT06720831
Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
An observational study of Female Genital Prolapse, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Female Genital Prolapse
- How many people
- 160 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2024to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with genital prolapse stage ≥ 2 according to the POP-Q classification undergoing laparoscopic sacroplexxy with mesh and laparoscopic sacropexy without mesh
Who may be able to join
- 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
Who cannot join
- Age > 80 years
- Previous genital prolapse surgery
Trial locations and contacts
2 sites in 1 country.
Manuela Maletta, MD contact
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Verona, 37126
Stefano Scarperi, MD, +393207081860, stefano.scarperi@aovr.veneto.it
About this study
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.
Read the 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.
- Conditions
- Female Genital Prolapse
- Keywords
- prolapse, female genital, gynaecology, sacropexy, mesh
- Medical subject headings
- Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months after surgery
Secondary outcomes (4)
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
Measured: 24 months after surgery
Rate of intraoperative and postoperative complications
Evaluation of intraoperative and postoperative complications according to the Clavien-Dindo classification
Measured: 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
Measured: 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
Measured: Before surgery and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital ProlapseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego Raimondo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720831
- Sponsor's protocol ID
- SACROMESH
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
- ClinicalTrials.gov ID
- NCT06720831
- Acronym / sponsor ID
- SACROMESH
- Conditions
- Female Genital Prolapse
- Keywords
- prolapse, female genital, gynaecology, sacropexy, mesh
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with genital prolapse stage ≥ 2 according to the POP-Q classification undergoing laparoscopic sacroplexxy with mesh and laparoscopic sacropexy without mesh
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Age > 80 years
- Previous genital prolapse surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence rate of central pelvic organ prolapse
Time frame: 24 months after surgery
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Maletta, MD contact
Diego Raimondo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Genital Prolapse, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Raimondo, MD (+393290636618, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of central pelvic organ prolapse (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.