Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Clinical Assessment and Procedures
2.3. Outcome Measures
2.4. Statistical Analysis
3. Results
3.1. Primary and Secondary Outcomes
3.1.1. Objective and Subjective Cure
3.1.2. Recurrence, Re-Surgery, and Post-Operative Complications
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | ALS (n = 200) | ASC (n = 100) | p-value |
---|---|---|---|
Age (years), mean (SD) | 63.1 (8.1) | 64.9 (8.8) | 0.152 |
BMI (kg/m2), mean (SD) | 24 (2.4) | 24.5 (1.8) | 0.163 |
Multiparous, n (%) | 197 (98.5%) | 95 (95%) | 0.122 |
Vaginal Delivery, n (%) | 197 (98.5%) | 94 (94%) | 0.064 |
Menopausal Status, n (%) | 169 (84.5%) | 92 (92%) | 0.072 |
Hysterectomy Prior Surgery, n (%) | 7 (3.5%) | 34 (34%) | <0.001 |
Apical Prolapse Stage ≥ II | 200 (100%) | 100 (100%) | >0.999 |
Stage II | 54 (27%) | 15 (15%) | |
Stage III | 101 (50.5%) | 50 (50%) | |
Stage IV | 45 (22.5%) | 35 (35%) | |
Anterior Prolapse Stage ≥ II | 186 (93%) | 72 (72%) | <0.001 |
Stage II | 39 (19.5%) | 15 (15%) | |
Stage III | 94 (47%) | 35 (35%) | |
Stage IV | 53 (26.5%) | 22 (22%) | |
Posterior Prolapse Stage ≥ II | 12 (6%) | 55 (55%) | <0.001 |
Stage II | 10 (5%) | 24 (24%) | |
Stage III | 2 (1%) | 20 (20%) | |
Stage IV | 0 (0%) | 11 (11%) |
Characteristics | ALS (n = 200) | ASC (n = 100) | p-value |
---|---|---|---|
Hysterectomy during surgery, n (%) | 6 (3%) | 33 (33%) | <0.001 |
Intraoperative Complication, n (%) | 0 (0%) | 1 (1%) | 0.110 |
Operative Time (minutes), mean (SD) | 123 (33) | 193 (55.6) | <0.001 |
Apical Recurrence | ALS (n = 200) | ASC (n = 100) | p-value |
---|---|---|---|
No | 184 (92%) | 94 (94%) | 0.642 |
Yes | 16 (8%) | 6 (6%) | |
Re-Surgery | 5 (2.5%) | 2 (2%) | >0.999 |
Percentage ALS (99% CI) | Percentage ASC | p-value (non-inf.) |
---|---|---|
8 (3.9–14.2) | 6 (1.7–14.9) | <0.01 |
Anterior Recurrence | ALS (n = 186) | ASC (n = 72) | p-value |
---|---|---|---|
no | 156 (83.9%) | 58 (80.6%) | 0.580 |
yes | 30 (16.1%) | 14 (19.4%) | |
Repeat Surgery | 4 (2.1%) | 4 (5.5) | 0.242 |
Posterior Recurrence | ALS (n = 12) | ASC (n = 55) | p-value |
no | 6 (50%) | 47 (85.4%) | 0.013 |
yes | 6 (50%) | 8 (14.6%) | |
Repeat Surgery | 1 (8.3%) | 0 (0%) | 0.429 |
Characteristic | ALS (n = 200) | ASC (n = 100) | p-value |
---|---|---|---|
Clavien-Dindo < 30 days | 0.476 | ||
Grade 1 | 10 (5.0%) | 3 (3.0%) | |
Grade 2 | 2 (1.0%) | 3 (3.0%) | |
Grade 3a | 1 (0.5%) | 1 (1.0%) | |
Grade 3b | 0 (0.0%) | 0 (0.0%) | |
Grade 4 | 0 (0.0%) | 0 (0.0%) | |
Grade 5 | 0 (0.0%) | 0 (0.0%) | |
Clavien-Dindo > 30 days | 0.472 | ||
Grade 1 | 12 (6.0%) | 0 (0.0%) | |
Grade 2 | 0 (0.0%) | 2 (2.0%) | |
Grade 3a | 4 (2.0%) | 3 (3.0%) | |
Grade 3b | 0 (0.0%) | 0 (0.0%) | |
Grade 4 | 0 (0.0%) | 0 (0.0%) | |
Grade 5 | 0 (0.0%) | 0 (0.0%) |
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Russo, E.; Montt Guevara, M.M.; Sacinti, K.G.; Misasi, G.; Falcone, M.; Morganti, R.; Mereu, L.; Dalprà, F.; Tateo, S.; Simoncini, T. Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial. J. Clin. Med. 2023, 12, 2926. https://doi.org/10.3390/jcm12082926
Russo E, Montt Guevara MM, Sacinti KG, Misasi G, Falcone M, Morganti R, Mereu L, Dalprà F, Tateo S, Simoncini T. Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial. Journal of Clinical Medicine. 2023; 12(8):2926. https://doi.org/10.3390/jcm12082926
Chicago/Turabian StyleRusso, Eleonora, Maria Magdalena Montt Guevara, Koray Gorkem Sacinti, Giulia Misasi, Maria Falcone, Riccardo Morganti, Liliana Mereu, Francesca Dalprà, Saverio Tateo, and Tommaso Simoncini. 2023. "Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial" Journal of Clinical Medicine 12, no. 8: 2926. https://doi.org/10.3390/jcm12082926
APA StyleRusso, E., Montt Guevara, M. M., Sacinti, K. G., Misasi, G., Falcone, M., Morganti, R., Mereu, L., Dalprà, F., Tateo, S., & Simoncini, T. (2023). Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial. Journal of Clinical Medicine, 12(8), 2926. https://doi.org/10.3390/jcm12082926