1. Robotic Enhanced-View Totally Extraperitoneal vs Intraperitoneal Onlay Mesh Evaluation: 1-Year Exploratory Outcomes of the REVEAL Randomized Clinical Trial.
- Author
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Petro, Clayton C., Maskal, Sara M., Renton, David B., Yunis, Jonathan P., Meara, Michael P., Diaz, Kayla, Wilber, Melanie, McKenzie, Kristen, Chao Tu, Phillips, Sharon E., Miller, Benjamin T., Beffa, Lucas R., Rosen, Michael J., and Prabhu, Ajita S.
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PERITONEUM surgery , *EVALUATION of medical care , *CONFIDENCE intervals , *SURGICAL robots , *RANDOMIZED controlled trials , *COMPARATIVE studies , *SURGICAL meshes , *QUESTIONNAIRES , *REOPERATION , *HERNIA , *QUALITY of life , *DESCRIPTIVE statistics , *ODDS ratio , *DATA analysis software - Abstract
BACKGROUND: Patients with small- to medium-sized ventral hernias randomized to robotic enhanced-view totally extraperitoneal (eTEP) or robotic intraperitoneal onlay mesh (rIPOM) previously demonstrated comparable 30-day patient-reported outcomes. Here we report 1-year exploratory outcomes for this multi-center, patient-blinded randomized clinical trial. STUDY DESIGN: Patients with midline ventral hernias 7 cm wide or less undergoing mesh repair were randomized to robotic eTEP or rIPOM. Planned exploratory outcomes at 1 year include pain intensity (using the Patient-Reported Outcomes Measurement Information system [PROMIs 3a]), Hernia-Related Quality of Life survey (HerQLes) scores, pragmatic hernia recurrence, and reoperation. RESULTS: One hundred randomized patients (51 eTEP, 49 rIPOM) reached a median 12-month follow-up (interquartile range 11 to 13) with 7% lost. After regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1-year for eTEP compared with rIPOM (odds ratio [OR] 2.1 [95% CI 0.85 to 5.1]; p = 0.11). HerQLes scores were 15 points lower on average (ie less improved) at 1 year after eTEP repairs compared with rIPOM, a difference maintained after regression analysis (OR 0.31 [95% CI 0.15 to 0.67]; p = 0.003). Pragmatic hernia recurrence was 12.2% (6 of 49) for eTEP and 15.9% (7 of 44) for rIPOM (p = 0.834). In the first year, 2 eTEP and 1 rIPOM patients required reoperations related to their index repair (p = 0.82). CONCLUSIONS: Exploratory analyses showed similar outcomes at 1 year in regard to pain, hernia recurrence, and reoperation. Abdominal wall quality of life at 1 year appears to favor rIPOM, and the possibility that an eTEP dissection is less advantageous in that regard should be the subject of future investigation. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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