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Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse

NCT ID: NCT06720831

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-03-31

Brief Summary

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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

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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

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Female Genital Prolapse

Keywords

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prolapse female genital gynaecology sacropexy mesh

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diego Raimondo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Verona, Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Diego Raimondo, MD

Role: CONTACT

Phone: +393290636618

Email: [email protected]

Manuela Maletta, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Diego Raimondo, MD

Role: primary

Stefano Scarperi, MD

Role: primary

Other Identifiers

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SACROMESH

Identifier Type: -

Identifier Source: org_study_id