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
Ciscar Bellés, Ana (Hospital Universitari Vall d'Hebron)
Sánchez-Sáez, Emma (Hospital de Sant Boi. Parc Sanitari Sant Joan de Deu)
Vila-Tura, Marina (Hospital Universitari de Bellvitge)
Ruiz de León, Patricia (Fundació Privada Hospital Assil de Granollers)
Gomez Pallarès, Marta (Hospital de Calella. Corporació de Salut del Maresme I La Selva)
Troyano Escribano, Daniel (Fundació Hospital de L'Esperit Sant)
Abadal Prades, Marta (Hospital de Mataró. Consorci Sanitari del Maresme)
Mans, Esther (Hospital de Mataró. Consorci Sanitari del Maresme)
Pereira-Rodríguez, José Antonio (Parc de Salut MAR de Barcelona)
Badia, Josep M (Hospital General de Granollers)
Universitat Autònoma de Barcelona. Departament de Cirurgia

Data:	2024
Resum:	Purpose: Trocar 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. Methods: A multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age ≥ 70 years and/or BMI ≥ 30 kg/m 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). Results: One 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). Conclusion: Our 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 registration: ClinicalTrials. org NCT03495557. Date of registration: April 12, 2018.
Nota:	Altres ajuts: acords transformatius de la UAB
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Trocar site incisional hernia ; Port site hernia ; Incidence ; Prophylactic mesh ; Randomized clinical trial
Publicat a:	Hernia, Vol. 28, Num. 6 (December 2024) , ISSN 1248-9204

DOI: 10.1007/s10029-024-03124-7
PMID: 39207550

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