Robotic Enhanced-View Totally Extraperitoneal vs Intraperitoneal Onlay Mesh Evaluation: 1-Year Exploratory Outcomes of the REVEAL Randomized Clinical Trial.
Autor: | Petro CC; From the Department of Surgery, Center for Abdominal Core Health (Petro, Maskal, Miller, Beffa, Rosen, Prabhu), Cleveland Clinic Foundation, Cleveland, OH., Maskal SM; From the Department of Surgery, Center for Abdominal Core Health (Petro, Maskal, Miller, Beffa, Rosen, Prabhu), Cleveland Clinic Foundation, Cleveland, OH., Renton DB; Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH (Renton, Meara, Diaz)., Yunis JP; Center for Hernia Repair, Sarasota Memorial Hospital, Sarasota, FL (Yunis, Wilber, McKenzie)., Meara MP; Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH (Renton, Meara, Diaz)., Diaz K; Department of Surgery, Center for Abdominal Core Health, The Ohio State University Wexner Medical Center, Columbus, OH (Renton, Meara, Diaz)., Wilber M; Center for Hernia Repair, Sarasota Memorial Hospital, Sarasota, FL (Yunis, Wilber, McKenzie)., McKenzie K; Center for Hernia Repair, Sarasota Memorial Hospital, Sarasota, FL (Yunis, Wilber, McKenzie)., Tu C; Department of Statistics (Tu), Cleveland Clinic Foundation, Cleveland, OH., Phillips SE; the Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN (Phillips)., Miller BT; From the Department of Surgery, Center for Abdominal Core Health (Petro, Maskal, Miller, Beffa, Rosen, Prabhu), Cleveland Clinic Foundation, Cleveland, OH., Beffa LR; From the Department of Surgery, Center for Abdominal Core Health (Petro, Maskal, Miller, Beffa, Rosen, Prabhu), Cleveland Clinic Foundation, Cleveland, OH., Rosen MJ; From the Department of Surgery, Center for Abdominal Core Health (Petro, Maskal, Miller, Beffa, Rosen, Prabhu), Cleveland Clinic Foundation, Cleveland, OH., Prabhu AS; From the Department of Surgery, Center for Abdominal Core Health (Petro, Maskal, Miller, Beffa, Rosen, Prabhu), Cleveland Clinic Foundation, Cleveland, OH. |
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Jazyk: | angličtina |
Zdroj: | Journal of the American College of Surgeons [J Am Coll Surg] 2023 Oct 01; Vol. 237 (4), pp. 614-620. Date of Electronic Publication: 2023 Jun 13. |
DOI: | 10.1097/XCS.0000000000000784 |
Abstrakt: | 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. (Copyright © 2023 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.) |
Databáze: | MEDLINE |
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