The MESH-RTL Project for prevention of abdominal wound dehiscence (AWD) in high-risk patients: noninferiority, randomized controlled trial

To compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial. Patients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale...

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Bibliographic Details
Published in:	Surgical endoscopy
Main Authors:	Lozada Hernández, Edgard Efrén, Flores González, Eduardo, Chavarría Chavira, Jose Luis, Hernandez Herrera, Bruno, Rojas Benítez, Cesar Gustavo, García Bravo, Luis Manuel, Sanchez Rosado, Rodolfo Raul, Reynoso González, Ricardo, Gutiérrez Neri Perez, Mariana, Reynoso Barroso, Maria Fernanda, Soria Rangel, Javier
Format:	Journal Article
Language:	English
Published:	Germany 25-10-2024
Subjects:	Prevention Reinforced tension line Mesh onlay position Abdominal wound dehiscence Noninferiority clinical trial
Online Access:	Get full text
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Summary:	To compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial. Patients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale were included. The outcomes analyzed were the incidence of AWD and surgical site occurrence (SSO). 239 patients were included: 121 mesh group and 118 RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p = 0.56, RR = 0.69, 95% CI = 0.22-2.13) in the per-protocol analysis. The median time of presentation was 6 days. The 95% CI (-0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications did not significantly differ between the two groups: the mesh group (27, 22.3%) and the RTL group (16, 12.8%) (p = 0.09, RR (95% CI) = 1.64 (0.93-2.89)). The use of the RTL technique for preventing AWD was not inferior to the use of mesh in the onlay position, nor did it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0930-2794 1432-2218 1432-2218
DOI:	10.1007/s00464-024-11358-w