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NCT Number: NCT06720831

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

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.

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Key information

Conditions

Female Genital Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Recurrence rate of central pelvic organ prolapse in laparoscopic sacral hysteropexy, sacralcervicopexy and sacralcolpopexy

    Time frame: 24 months after surgery

    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

  2. Rate of intraoperative and postoperative complications

    Time frame: During surgery and within 30 days

    Evaluation of intraoperative and postoperative complications according to the Clavien-Dindo classification

  3. Modification of symptoms after surgery

    Time frame: Before surgery and 24 months after surgery

    Change in pre- and post-operative symptomatology assessed through the completion of a questionnaire

  4. Changes in the disease framework

    Time frame: Before surgery and 24 months after surgery

    Change in the disease framework of pelvic organ prolapse according to the POP-Q classification assessed before and after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Raimondo, MD

CONTACT

[email protected]

+393290636618

Manuela Maletta, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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