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NCT Number: NCT06815731

Multicenter Study on the Correction of Prolapse Via Laparoscopy

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HCUVA

Murcia, 30120, Spain

Location status: Recruiting

Location contact

Maria Luisa Sanchez Ferrer, MD

CONTACT

[email protected]

About this study

In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.

Exclusion criteria

  • History of abdominal prolapse reconstructive surgery.
  • History of prolapse reconstructive surgery with vaginal meshes.
  • Stage I according to the POP-Q classification or asymptomatic prolapse.
  • Medical contraindication for general anaesthesia.
  • Patient preference for vaginal surgical treatment.
  • Patient does not wish to participate in the study.

Treatment and study plan

lateral laparoscopic suspension (LLS)

Procedure

lateral laparoscopic suspension (LLS)

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Procedure

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Primary outcomes

  1. Pelvic Organ Prolapse Distress Inventory

    Time frame: up to 12 months

    Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6

  2. Colorectal-Anal Distress Inventory

    Time frame: up to 12 months

    Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8

  3. Urinary Distress Inventory

    Time frame: up to 12 months

    Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.

  4. Number of patients with symptomatic failure

    Time frame: up to 12 months

    Number of patients with symptomatic failure , defined as a positive response (accompanied by any degree of discomfort) to the following question on the validated questionnaire regarding prolapse symptoms (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"

Secondary outcomes

  1. Intestinal and pain symptoms

    Time frame: up to 12 months

    Subjective or functional success is defined as an improvement of ≥15 points per domain (the minimally important difference) or a decrease in the total score of 45 points (the minimally important difference). The PISQ-2 questionnaire has a score range between 0 and 48, and a difference ≥ 6 points is considered a minimally important difference.

  2. Anatomical result

    Time frame: up to 12 months

    Anatomical results are defined as any POP-Q measurement below the hymen.

    Anatomical variables of prolapse: POPQ classification :

    • Anterior compartment: Aa, Ba
    • Middle compartment: C or D
    • Posterior compartment: Ap, Bp

Study contacts

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

María Luisa Sánchez Ferrer, MD

CONTACT

[email protected]

968369500

Sponsors and collaborators

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

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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