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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lateral laparoscopic suspension (LLS) | Experimental |
| |
| Sacropexy without posterior mesh fixation on the puborrectalis muscle | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lateral laparoscopic suspension (LLS) | Procedure | lateral laparoscopic suspension (LLS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Organ Prolapse Distress Inventory | Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6 | up to 12 months |
| Colorectal-Anal Distress Inventory | Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8 | up to 12 months |
| Urinary Distress Inventory | Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6. | up to 12 months |
| Number of patients with symptomatic failure | 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?" | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal and pain symptoms | 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. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MarÃa Luisa Sánchez Ferrer, MD | Contact | 968369500 | marisasanchezferrer1@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCUVA | Recruiting | Murcia | 30120 | Spain |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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| Sacropexy without posterior mesh fixation on the puborrectalis muscle | Procedure | Sacropexy without posterior mesh fixation on the puborrectalis muscle |
|
| Anatomical result | Anatomical results are defined as any POP-Q measurement below the hymen. Anatomical variables of prolapse: POPQ classification :
| up to 12 months |
| D052801 | Male Urogenital Diseases |