The DySLOH Study: Comparative Evaluation of the Results between the ProFlor and Lichtenstein Techniques for Open Inguinal Hernia Repair—A Randomized Controlled Trial
Abstract
:1. Introduction
2. Methods
2.1. Patient Selection
2.2. Patient Enrollment and Preoperative Schedule
2.3. Devices and Surgical Techniques
- After making a skin incision, the external oblique fascia was opened. The hernia sac was identified and dissected.
- In the case of a large indirect hernia, the sac was opened, emptied of its contents, sutured at the base, and cut short. The remaining portion of the sac was then returned to the abdominal cavity. In the case of small sac, this could be returned intact to the abdominal cavity.
- For direct or combined hernias, the sac was usually not opened and the protrusion was returned back to the abdominal cavity. Then the transversalis fascia was lifted and secured with a continuous polypropylene suture.
- The mesh was then deployed to cover the anterior aspect of the entire inguinal floor. To accommodate the spermatic cord passing over the mesh, a slit was made in the upper part of the implant. The cord was positioned on the external surface of the mesh and sutured in place.
- The mesh was fixated without tension on the myotendineal structures of the groin using four to six interrupted stitches made with 2-0 polypropylene monofilament (Figure 2B).
- Finally, wound closure was performed as usual.
2.4. Postoperative Evaluation
2.5. Statistical Analysis
3. Results
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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Exclusion Criteria |
---|
Recurrent inguinal hernia Incarcerated inguinal hernia Hernia not in the inguinal area Signs of obvious local or systemic infection ASA score > 4 Presenting with unstable angina or NYHA class of IV Pregnant Active drug user Immunosuppression, chemotherapy Chronic renal insufficiency Abdominal ascites Infection in the area of the surgical field BMI > 35 |
Lichtenstein (n = 93) Mean ± SD | ProFlor (n = 95) Mean ± SD | Total (n = 188) Mean ± SD | p-Value | |
---|---|---|---|---|
Age | Years 59.7 ± 32 | Years 59.6 ± 33.2 | Years 59.7 ± 33 | 1.000 |
Gender | ||||
M | 86 (92.5%) | 93 (97.9%) | 179 (95.2%) | 0.802 |
F | 7 (7.5%) | 2 (2.1%) | 9 (4.7%) | 0.272 |
Body Mass Index | 26.8 ± 5.6 | 27 ± 7.8 | 26.9 ± 7.8 | 0.998 |
Comorbidity | 45 (48.4%) | 40 (42.1%) | 85 (45.2%) | 0.719 |
Cardiovascular | 26 (28%) | 28 (29.4%) | 54 (28.7%) | |
Pulmonary | 6 (6.4%) | 2 (2.1%) | 8 (4.2%) | |
Diabetes | 6 (6.4%) | 5 (5.3%) | 11 (5.8%) | |
Others | 7 (7.5%) | 5 (5.3%) | 12 (6.4%) | |
ASA score | ||||
ASA 1 | 48 (51.6%) | 55 (57.8%) | 103 (54.8%) | 0.667 |
ASA 2 | 36 (38.7%) | 34 (35.8%) | 70 (37.2%) | 0.576 |
ASA 3 | 9 (9.7%) | 6 (6.3%) | 15 (8%) | 0.562 |
Lichtenstein (n = 93) | ProFlor (n = 95) | Total (n = 188) | p-Value | |
---|---|---|---|---|
Hernia types | Overall (%) | Overall (%) | Overall (%) | |
Indirect | 46 (49.4%) | 39 (41%) | 88 (46.8%) | 0.37 |
Direct | 34 (36.5%) | 18 (18.9%) | 53 (28.2) | 0.021 |
Combined | 13 (14%) | 19 (20%) | 32 (17%) | 0.59 |
Supravesical | NA | 7 (7.3%) | 7 (3.7%) | NA |
Multiple ipsilateral | NA | 12 (12.6%) | 12 (6.7%) | NA |
Side | ||||
Right | 51 (54.8%) | 51 (53.7%) | 102 (54.2%) | 0.818 |
Left | 42 (45.2%) | 44 (46.3%) | 86 (45.7%) | 0.818 |
Defect size (cm) | 2.4 ± 1.5 | 2.8 ± 1.8 | 2.6 ± 1.85 | 0.684 |
Procedure duration | 56 min ± 24.6 | 42 min ± 15.4 | 48.5 min ± 19.2 | 0.028 |
Lichtenstein (n = 93) n. (%) | ProFlor (n = 95) n. (%) | p-Value | |
---|---|---|---|
Intraoperative complications | 1 (1.1%) (epigastric vessel bleeding) | - | 0.998 |
Early complications | |||
Seroma | 6 (6.4%) | 3 (3.1%) | |
Hematoma | 4 (4.3%) | - | |
Wound infection | 1 (1.1%) | - | |
Recurrence | 0 (0%) | 0 (0%) | |
Early complications (all) | 11 (11.8%) | 3 (3.1) | 0.029 |
Late complications | |||
Chronic pain | 11 (11.8%) | 0 (0%) | |
Testicular swelling | 3 (3.2%) | 0 (0%) | |
Recurrence | 4 (4.3%) | 0 (0%) | |
Late complications (all) | 18 (19.3%) | 0 (0%) | 0.002 |
VAS Scores POD 0/10/30 | |||
---|---|---|---|
Lichtenstein (n = 93) Mean ± SD | ProFlor (n = 95) Mean ± SD | p-Value | |
POD O | 5.7 ± 1.9 | 2.6 ± 0.8 | 0.016 |
POD 10 | 3.1 ± 1.7 | 0.2 ± 0.6 | 0.016 |
POD 30 | 1.8 ± 1.2 | - | 0.634 |
1 Month Lichtenstein/ProFlor | 6 Months Lichtenstein/ProFlor | 12 Months Lichtenstein/ProFlor | 24 Months Lichtenstein/ProFlor | |
---|---|---|---|---|
Laying down | ||||
A. sensation of mesh | 2.61/1.15 | 1.26/0.18 | 0.28/0.01 | 0.01/0.00 |
B. pain | 2.12/0.91 | 1.15/0.20 | 0.15/0.00 | 0.00/0.00 |
Bending over | ||||
A. sensation of mesh | 3.10/1.0 | 1.30/0.25 | 0.54/0.00 | 0.03/0.01 |
B. pain | 2.42/0.81 | 1.56/0.22 | 0.41/0.01 | 0.02/0.00 |
C. movement limitations | 2.63/0.82 | 1.85/0.36 | 0.52/0.10 | 0.02/0.00 |
Sitting | ||||
A. sensation of mesh | 3.05/0.77 | 1.23/0.32 | 0.50/0.01 | 0.02/0.01 |
B. pain | 2.09/0.75 | 1.12/0.31 | 0.42/0.06 | 0.01/0.01 |
C. movement limitations | 2.61/0.82 | 1.85/0.28 | 0.51/0.05 | 0.04/0.03 |
Activities of daily living | ||||
A. sensation of mesh | 2.45/0.75 | 1.05/0.15 | 0.44/0.02 | 0.05/0.01 |
B. pain | 2.95/0.67 | 1.52/0.23 | 0.36/0.03 | 0.03/0.01 |
C. movement limitations | 2.84/0.71 | 1.95/0.20 | 0.36/0.10 | 0.04/0.00 |
Coughing or deep breathing | ||||
A. sensation of mesh | 2.25/0.68 | 1.25/0.32 | 0.69/0.06 | 0.03/0.02 |
B. pain | 3.12/0.83 | 1.38/0.24 | 0.70/0.03 | 0.02/0.02 |
C. movement limitations | 2.75/0.64 | 1.44/0.20 | 0.70/0.04 | 0.04/0.01 |
Walking | ||||
A. sensation of mesh | 3.15/0.55 | 1.18/0.16 | 0.32/0.02 | 0.01/0.00 |
B. pain | 2.78/0.50 | 1.20/0.14 | 0.43/0.03 | 0.01/0.01 |
C. movement limitations | 2.67/0.51 | 1.29/0.14 | 0.48/0.03 | 0.00/0.00 |
Stairs | ||||
A. sensation of mesh | 2.08/0.66 | 1.62/0.21 | 0.56/0.030 | 0.02/0.02 |
B. pain | 2.80/0.52 | 1.35/0.17 | 0.50/0.02 | 0.02/0.01 |
C. movement limitations | 2.72/0.54 | 1.32/0.18 | 0.51/0.00 | 0.01/0.00 |
Exercise | ||||
A. sensation of mesh | 2.10/0.51 | 1.80/0.14 | 0.87/0.01 | 0.06/0.00 |
B. pain | 2.63/0.85 | 1.42/0.21 | 0.55/0.01 | 0.04/0.01 |
C. movement limitations | 3.25/0.95 | 1.99/0.23 | 0.55/0.08 | 0.02/0.00 |
Overall | 61.17/16.90 | 33.08/5.04 | 11.35/0.75 | 0.55/0.18 |
Mean | 2.66/0.73 | 1.44/0.21 | 0.49/0.03 | 0.02/0.008 |
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Romano, G.; Di Buono, G.; Rodolico, V.; Romano, G.; Barletta, G.; Zanghì, G.; Calò, P.G.; Buscemi, S.; Agrusa, A. The DySLOH Study: Comparative Evaluation of the Results between the ProFlor and Lichtenstein Techniques for Open Inguinal Hernia Repair—A Randomized Controlled Trial. J. Clin. Med. 2024, 13, 5530. https://doi.org/10.3390/jcm13185530
Romano G, Di Buono G, Rodolico V, Romano G, Barletta G, Zanghì G, Calò PG, Buscemi S, Agrusa A. The DySLOH Study: Comparative Evaluation of the Results between the ProFlor and Lichtenstein Techniques for Open Inguinal Hernia Repair—A Randomized Controlled Trial. Journal of Clinical Medicine. 2024; 13(18):5530. https://doi.org/10.3390/jcm13185530
Chicago/Turabian StyleRomano, Giorgio, Giuseppe Di Buono, Vito Rodolico, Giorgio Romano, Gabriele Barletta, Guido Zanghì, Pietro Giorgio Calò, Salvatore Buscemi, and Antonino Agrusa. 2024. "The DySLOH Study: Comparative Evaluation of the Results between the ProFlor and Lichtenstein Techniques for Open Inguinal Hernia Repair—A Randomized Controlled Trial" Journal of Clinical Medicine 13, no. 18: 5530. https://doi.org/10.3390/jcm13185530