Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial)
Abstract Background Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of...
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| Format: | Article |
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BMC
2023-02-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07089-3 |
| _version_ | 1828041457810800640 |
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| author | Sven Müller Dirk Weyhe Florian Herrle Philipp Horvath Robert Bachmann Viktor von Ehrlich-Treuenstätt Patrick Heger Nadir Nasir Christina Klose Alexander Ritz Anja Sander Erich Grohmann Colette Dörr-Harim André L. Mihaljevic |
| author_facet | Sven Müller Dirk Weyhe Florian Herrle Philipp Horvath Robert Bachmann Viktor von Ehrlich-Treuenstätt Patrick Heger Nadir Nasir Christina Klose Alexander Ritz Anja Sander Erich Grohmann Colette Dörr-Harim André L. Mihaljevic |
| author_sort | Sven Müller |
| collection | DOAJ |
| description | Abstract Background Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone. Methods P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification. Discussion Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal. Trial registration DRKS00027921, U1111-1273-4657 |
| first_indexed | 2024-04-10T17:16:29Z |
| format | Article |
| id | doaj.art-b0d96b5c21f145439022211ac9c224ce |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-10T17:16:29Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
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| spelling | doaj.art-b0d96b5c21f145439022211ac9c224ce2023-02-05T12:22:59ZengBMCTrials1745-62152023-02-0124111710.1186/s13063-023-07089-3Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial)Sven Müller0Dirk Weyhe1Florian Herrle2Philipp Horvath3Robert Bachmann4Viktor von Ehrlich-Treuenstätt5Patrick Heger6Nadir Nasir7Christina Klose8Alexander Ritz9Anja Sander10Erich Grohmann11Colette Dörr-Harim12André L. Mihaljevic13Helios Klinikum GifhornKlinik für Allgemein- und Viszeralchirurgie, Universitätsmedizin Oldenburg, Pius-Hospital OldenburgChirurgische Klinik, Universitätsklinikum MannheimKlinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenKlinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenKlinik für Allgemein-, Viszeral- und Transplantationschirurgie, Ludwig-Maximilians-Universität MünchenDepartment of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital UlmDepartment of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital UlmInstitute of Medical Biometry (IMBI), University of HeidelbergInstitute of Medical Biometry (IMBI), University of HeidelbergInstitute of Medical Biometry (IMBI), University of HeidelbergDeutsche ILCO e. V.Department of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital UlmDepartment of General and Visceral Surgery and Clinical Trial Centre Department of Surgery (ulmCARES), University Hospital UlmAbstract Background Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone. Methods P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 μm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification. Discussion Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal. Trial registration DRKS00027921, U1111-1273-4657https://doi.org/10.1186/s13063-023-07089-3Incisional herniaSurgical meshPatient-reported outcome measuresPostoperative complicationsRandomised controlled trial |
| spellingShingle | Sven Müller Dirk Weyhe Florian Herrle Philipp Horvath Robert Bachmann Viktor von Ehrlich-Treuenstätt Patrick Heger Nadir Nasir Christina Klose Alexander Ritz Anja Sander Erich Grohmann Colette Dörr-Harim André L. Mihaljevic Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) Trials Incisional hernia Surgical mesh Patient-reported outcome measures Postoperative complications Randomised controlled trial |
| title | Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) |
| title_full | Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) |
| title_fullStr | Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) |
| title_full_unstemmed | Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) |
| title_short | Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) |
| title_sort | prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence a multicentre randomised patient and observer blind trial p e l i o n trial |
| topic | Incisional hernia Surgical mesh Patient-reported outcome measures Postoperative complications Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-023-07089-3 |
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