Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial
Background - Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted P...
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| Hauptverfasser: | , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
January 2024
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| In: |
The lancet. Regional health
Year: 2024, Jahrgang: 36, Pages: 1-8 |
| ISSN: | 2666-7762 |
| DOI: | 10.1016/j.lanepe.2023.100787 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.lanepe.2023.100787 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S2666776223002065 
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| Verfasserangaben: | Louis Matthijs Van den Dop, Dimitri Sneiders, Yagmur Yurtkap, Alexander Werba, David van Klaveren, Robert E.G.J.M. Pierik, Daniel Reim, Lucas Timmermans, René H. Fortelny, André L. Mihaljevic, Gert-Jan Kleinrensink, Pieter J. Tanis, Johan F. Lange, and Johannes Jeekel, for the PRIMA Trialist Group |
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| 245 | 1 | 0 | |a Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA) |b long-term outcomes of a multicentre, double-blind, randomised controlled trial |c Louis Matthijs Van den Dop, Dimitri Sneiders, Yagmur Yurtkap, Alexander Werba, David van Klaveren, Robert E.G.J.M. Pierik, Daniel Reim, Lucas Timmermans, René H. Fortelny, André L. Mihaljevic, Gert-Jan Kleinrensink, Pieter J. Tanis, Johan F. Lange, and Johannes Jeekel, for the PRIMA Trialist Group |
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| 520 | |a Background - Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. - Methods - In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). - Findings - Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. - Interpretation - Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. - Funding - B. Braun. | ||
| 650 | 4 | |a Incisional hernia | |
| 650 | 4 | |a Onlay | |
| 650 | 4 | |a Primary suture | |
| 650 | 4 | |a Prophylactic mesh | |
| 650 | 4 | |a Sublay | |
| 700 | 1 | |a Sneiders, Dimitri |e VerfasserIn |4 aut | |
| 700 | 1 | |a Yurtkap, Yagmur |e VerfasserIn |4 aut | |
| 700 | 1 | |a Werba, Alexander |d 1993- |e VerfasserIn |0 (DE-588)1294988999 |0 (DE-627)1851793925 |4 aut | |
| 700 | 1 | |a van Klaveren, David |e VerfasserIn |4 aut | |
| 700 | 1 | |a Pierik, Robert E. G. J. M. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Reim, Daniel |e VerfasserIn |4 aut | |
| 700 | 1 | |a Timmermans, Lucas |e VerfasserIn |4 aut | |
| 700 | 1 | |a Fortelny, René H. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mihaljevic, André L. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kleinrensink, Gert-Jan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tanis, Pieter J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lange, Johan F. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Jeekel, Johannes |e VerfasserIn |4 aut | |
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