Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results
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The seroma rate following laparoscopic incisional ventral hernia repair (LIVHR) is up to 78%. LIVHR is connected to a relatively rare but dangerous complication, enterotomy, especially in cases with complex adhesiolysis. Closure of the fascial defect and extirpation of the hernia sack may reduce the risk of seromas and other hernia-site events. Our aim was to evaluate whether hybrid operation has a lower rate of the early complications compared to the standard LIVHR.
This is a multicenter randomized-controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomized to either a laparoscopic (LG) or to a hybrid (HG) repair group. The outcome measures were the incidence of clinically and radiologically detected seromas and their extent 1 month after surgery, peri/postoperative complications, and pain.
Bulging was observed by clinical evaluation in 46 (49%) LG patients and in 27 (31%) HG patients (p = 0.022). Ultrasound examination detected more seromas (67 vs. 45%, p = 0.004) and larger seromas (471 vs. 112 cm3, p = 0.025) after LG than after HG. In LG, there were 5 (5.3%) enterotomies compared to 1 (1.1%) in HG (p = 0.108). Adhesiolysis was more complex in LG than in HG (26.6 vs. 13.3%, p = 0.028). Patients in HG had higher pain scores on the first postoperative day (VAS 5.2 vs. 4.3, p = 0.019).
Closure of the fascial defect and extirpation of the hernia sack reduce seroma formation. In hybrid operations, the risk of enterotomy seems to be lower than in laparoscopic repair, which should be considered in cases with complex adhesions.
Clinical trial number
KeywordsIncisional ventral hernia Hybrid Seroma formation Enterotomy
Ahonen-Siirtola: conception and design of the study, acquisition, analysis, and interpretation of data, and writing the article. Nevala: design of the study, acquisition of data, writing the article, and critical revision. Vironen: design of the study, acquisition, analysis and interpretation of data, and critical revision. Kössi: design of the study, acquisition, analysis and interpretation of data, and critical revision. Pinta: design of the study, acquisition of data, and critical revision. Niemeläinen: design of the study, acquisition of data, and critical revision. Keränen: design of the study, acquisition of data, and critical revision. Ward: design of the study, acquisition of data, and critical revision. Vento: design of the study, acquisition of data, and critical revision. Karvonen: design of the study, acquisition of data, and critical revision. Ohtonen: design of the study, analysis and interpretation of data, writing the article, and critical revision. Mäkelä: conception and design of the study, and critical revision. Rautio: conception and design of the study, acquisition, analysis and interpretation of data, and writing the article.
Compliance with ethical standards
Conflict of interest
Authors MAS, TN, JV, TP, SN, UK, JW, PV, JK, PO, JM, and TR declare no conflict of interest. Author JK declares conflict of interest not directly related to the submitted work (one lecturing fee from Medtronic, not related to the submitted work).
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Human and animal rights
This article does not contain any studies with animals performed by any of the authors.
Informed consent was obtained from all individual participants included in the study.
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