Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
Por:
Ciscar A, Sánchez E, Vila Tura M, Ruiz de Leon P, Gomez Pallarès M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA and Badia JM
Publicada:
1 dic 2024
Ahead of Print:
1 ago 2024
Resumen:
PurposeTrocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lower rates of TSIH.MethodsA multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age >= 70 years and/or BMI >= 30 kg/m2 and/or extended incision for specimen retrieval) who underwent either elective or emergency laparoscopic cholecystectomy. Patients were assigned to prophylactic onlay polypropylene mesh fixation (intervention) or to standard trocar closure (control). The main aim was to analyze the efficacy of the intervention, taking occurrence of TSIH as the primary outcome. Clinical and radiological follow up lasted at least one year after surgery. Secondary endpoints were technique-related complications (surgical site occurrences).ResultsOne hundred and forty-three patients were randomized and finally 116 were analyzed (64 in the intervention arm and 52 in the control arm). Groups were homogeneous. Mean [SD] age, 65 [18] years; 86 (60.6%) were women. The cumulative TSIH incidence was lower in the intervention group although the differences did not reach statistical significance, assessed either radiologically (16 [25.4%] vs 17 [31.5%], p = 0.538) or clinically (9 [16.1%] vs 9 [20], p = 0.613). No differences in surgical site infection, hematoma or seroma were detected. Mean follow-up was 670 days (range 223-1294).ConclusionOur results show that, when properly assessed, the overall TSIH incidence is extremely high. Although polypropylene onlay mesh placement is safe, it does not appear to be effective in reducing the TSIH incidence rate. Radiological evaluation may be more accurate.Trial registrationClinicalTrials.org NCT03495557. Date of registration: April 12, 2018
Filiaciones:
Ciscar A:
Department of Surgery, UD de Medicina de la Vall d'Hebron, Universitat Autonoma de Barcelona, Edifici W, Passeig Vall d'Hebron, Barcelona, 08035, Spain
Hospital Universitari Vall d'Hebron, Barcelona, Spain
Sánchez E:
Hospital de Sant Boi, Parc Sanitari Sant Joan de Deu, Sant Boi, Spain
Vila Tura M:
Hospital Universitari de Bellvitge, Hospitalet del Llobregat, Spain
Ruiz de Leon P:
Fundació Hospital Asil de Granollers, Granollers, Spain
Gomez Pallarès M:
Hospital de Calella, Corporació de Salut del Maresme I La Selva, Calella, Spain
Troyano Escribano D:
Fundació Hospital de L'Esperit Sant, Santa Coloma de Gramenet, Spain
Abadal Prades M:
Hospital de Mataró. Department of Radiology. Consorci Sanitari del Maresme, Mataró, Spain
Mans Muntwyler E:
Hospital de Mataró. Department of Surgery. Consorci Sanitari del Maresme, Mataró, Spain
Pereira JA:
Abdominal Wall Unit, Department of General Surgery, Hospital del Mar. Parc de Salut Mar, Barcelona, Spain
Medicine and Life Sciences Department, Universitat Pompeu Fabra, Barcelona, Spain
Badia JM:
Hospital de Granollers, Granollers, Spain
School of Medicine, Universitat Internacional de Catalunya, Sarrià-Sant Gervasi, Barcelona, Spain
Green Submitted, hybrid
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