Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation
Introduction Incisional hernia (IH) is the most frequent mid-term and long-term complication after midline laparotomy. The current standard treatment includes repair using a mesh. In a contaminated field, the use of a non-absorbable mesh increases the risk of surgical site infection and the costs. S...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/8/e061184.full |
| _version_ | 1818495401046573056 |
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| author | Jennifer Margier Sylvie Bin Guillaume Passot Amaniel Kefleyesus Pascal Rousset Laurent Villeneuve Pablo Ortega-Deballon Yohann Renard |
| author_facet | Jennifer Margier Sylvie Bin Guillaume Passot Amaniel Kefleyesus Pascal Rousset Laurent Villeneuve Pablo Ortega-Deballon Yohann Renard |
| author_sort | Jennifer Margier |
| collection | DOAJ |
| description | Introduction Incisional hernia (IH) is the most frequent mid-term and long-term complication after midline laparotomy. The current standard treatment includes repair using a mesh. In a contaminated field, the use of a non-absorbable mesh increases the risk of surgical site infection and the costs. Slowly absorbable meshes are safe in contaminated fields, but no data have been reported regarding their long-term recurrence rate. COMpACT-BIO is a multicentre prospective randomised controlled phase III trial designed to compare the 3-year recurrence rate in patients undergoing contaminated IH repair with either a slowly absorbable mesh or standard care.Methods In patients undergoing midline IH repair in a contaminated surgical field (grade III of the modified Ventral Hernia Working Group classification), the COMpACT-BIO study compares the use of a slowly absorbable mesh with that of conventional care according to standardised surgical procedures (primary closure, non-absorbable synthetic mesh or biologic mesh, at the discretion of the surgeon). Randomisation is done during surgery before closure the fascia with an allocation ratio of 1:1. The choice of the slowly absorbable mesh is left to the criteria of each centre. The primary endpoint is the proportion of patients with scan-confirmed IH recurrence within 3 years after repair.Ethics/dissemination This trial is conducted in compliance with international standards for research practice and reporting. Written informed consent will be obtained from patients prior to inclusion. All data were identified and anonymised prior to analysis. The protocol has been approved by an Institutional Review Board (2020-A0823-36/SI:20.07.03.66831), and will be conducted in compliance with the CONSORT (Consolidated Standards of Reporting Trials) statement. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals.Protocol version Version 2—13 October 2020.Trial registration number NCT04597840. |
| first_indexed | 2024-12-10T18:20:06Z |
| format | Article |
| id | doaj.art-f61bb644e08b46a896dddf529fd28825 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-10T18:20:06Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-f61bb644e08b46a896dddf529fd288252022-12-22T01:38:14ZengBMJ Publishing GroupBMJ Open2044-60552022-08-0112810.1136/bmjopen-2022-061184Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluationJennifer Margier0Sylvie Bin1Guillaume Passot2Amaniel Kefleyesus3Pascal Rousset4Laurent Villeneuve5Pablo Ortega-Deballon6Yohann Renard78 Public Health, University Hospital Centre Lyon, Lyon, FranceService de Recherche Clinique et Epidémiologique, Pôle de Santé Publique, Hospices Civils de Lyon, Lyon, FranceDepartment of Surgical Oncology, Hopital Lyon Sud, Hospices Civils de Lyon, Pierre Bénite, FranceDepartment of Surgical Oncology, Hopital Lyon Sud, Hospices Civils de Lyon, Pierre Bénite, FranceRadiology, Centre Hospitalier Lyon-Sud, Pierre-Benite, FranceService de Recherche Clinique et Epidémiologique, Pôle de Santé Publique, Hospices Civils de Lyon, Lyon, FranceDepartement of General Surgery, Centre Hospitalier Universitaire du Bocage, Dijon, FranceDepartement of General Surgery, Reims Champagne-Ardenne University, Reims, FranceIntroduction Incisional hernia (IH) is the most frequent mid-term and long-term complication after midline laparotomy. The current standard treatment includes repair using a mesh. In a contaminated field, the use of a non-absorbable mesh increases the risk of surgical site infection and the costs. Slowly absorbable meshes are safe in contaminated fields, but no data have been reported regarding their long-term recurrence rate. COMpACT-BIO is a multicentre prospective randomised controlled phase III trial designed to compare the 3-year recurrence rate in patients undergoing contaminated IH repair with either a slowly absorbable mesh or standard care.Methods In patients undergoing midline IH repair in a contaminated surgical field (grade III of the modified Ventral Hernia Working Group classification), the COMpACT-BIO study compares the use of a slowly absorbable mesh with that of conventional care according to standardised surgical procedures (primary closure, non-absorbable synthetic mesh or biologic mesh, at the discretion of the surgeon). Randomisation is done during surgery before closure the fascia with an allocation ratio of 1:1. The choice of the slowly absorbable mesh is left to the criteria of each centre. The primary endpoint is the proportion of patients with scan-confirmed IH recurrence within 3 years after repair.Ethics/dissemination This trial is conducted in compliance with international standards for research practice and reporting. Written informed consent will be obtained from patients prior to inclusion. All data were identified and anonymised prior to analysis. The protocol has been approved by an Institutional Review Board (2020-A0823-36/SI:20.07.03.66831), and will be conducted in compliance with the CONSORT (Consolidated Standards of Reporting Trials) statement. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals.Protocol version Version 2—13 October 2020.Trial registration number NCT04597840.https://bmjopen.bmj.com/content/12/8/e061184.full |
| spellingShingle | Jennifer Margier Sylvie Bin Guillaume Passot Amaniel Kefleyesus Pascal Rousset Laurent Villeneuve Pablo Ortega-Deballon Yohann Renard Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation BMJ Open |
| title | Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation |
| title_full | Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation |
| title_fullStr | Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation |
| title_full_unstemmed | Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation |
| title_short | Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation |
| title_sort | slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia compact bio a multicentre randomised controlled phase iii trial including a health economic evaluation |
| url | https://bmjopen.bmj.com/content/12/8/e061184.full |
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