Pelvic Floor Disorders
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESacropexy without posterior mesh fixation on the puborrectalis muscle
Sacropexy without posterior mesh fixation on the puborrectalis muscle
PROCEDURElateral laparoscopic suspension (LLS)
lateral laparoscopic suspension (LLS)
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Distress Inventory | up to 12 months | Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6 |
| Colorectal-Anal Distress Inventory | up to 12 months | Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8 |
| Urinary Distress Inventory | up to 12 months | Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6. |
| Number of patients with symptomatic failure | 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
| Measure | Time frame | Description |
|---|---|---|
| Intestinal and pain symptoms | 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. |
| Anatomical result | 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 |
Countries
Spain
Contacts
Primary ContactMaría Luisa Sánchez Ferrer, MD
Outcome results
None listed