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
General Surgery, Department of Diseases of the Digestive Tract, Servicios de salud del Instituto Mexicano del Seguro Social Para El Bienestar (IMSS-BIENESTAR) Hospital Regional de Alta Especialidad del Bajío, Colonia Quinta los Naranjos, Circuito Quinta los Naranjos # 145 B, León, Guanajuato, México.
General Surgery, Department of Diseases of the Digestive Tract, Servicios de Salud del Instituto Mexicano del Seguro Social Para El Bienestar (IMSS-BIENESTAR) Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, México.
Surg Endosc. 2024 Dec;38(12):7634-7646. doi: 10.1007/s00464-024-11358-w. Epub 2024 Oct 25.
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).
在一项非劣效性临床试验中，比较用于预防腹壁伤口裂开（AWD）的外置位置的加强张力线（RTL）技术和网片技术。
纳入年龄>18岁、接受中线剖腹手术且根据改良鹿特丹风险量表被认为具有高风险的患者。分析的结局指标为AWD发生率和手术部位事件（SSO）。
共纳入239例患者：网片组121例，RTL组118例。在意向性分析中，网片组121例患者中有5例（4.1%）发生AWD，RTL组118例患者中有7例（5.9%）发生AWD（p = 0.56，RR = 0.69，95%CI = 0.22 - 2.13）。出现AWD的中位时间为6天。两组发生率差异的95%CI（-0.0567，0.0231）完全在预先定义的5%非劣效界值范围内。两组并发症发生率无显著差异：网片组（27例，22.3%）和RTL组（16例，12.8%）（p = 0.09，RR（95%CI）= 1.64（0.93 - 2.89））。
使用RTL技术预防AWD并不劣于使用外置位置的网片技术，也未增加并发症风险。本研究已在clinicaltrials.gov注册：网片-RTL项目（NCT04134455）。
