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.
Ana Ciscar, Emma Sánchez-Sáez, Marina Vila Tura, Patricia Ruiz de Leon, Marta Gomez Pallarès, Daniel Troyano Escribano, Marta Abadal Prades, Esther Mans Muntwyler, José-Antonio Pereira, Josep M Badia
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引用次数: 0
Abstract
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/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).
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.
期刊介绍：
Hernia was founded in 1997 by Jean P. Chevrel with the purpose of promoting clinical studies and basic research as they apply to groin hernias and the abdominal wall . Since that time, a true revolution in the field of hernia studies has transformed the field from a ”simple” disease to one that is very specialized. While the majority of surgeries for primary inguinal and abdominal wall hernia are performed in hospitals worldwide, complex situations such as multi recurrences, complications, abdominal wall reconstructions and others are being studied and treated in specialist centers. As a result, major institutions and societies are creating specific parameters and criteria to better address the complexities of hernia surgery.
Hernia is a journal written by surgeons who have made abdominal wall surgery their specific field of interest, but we will consider publishing content from any surgeon who wishes to improve the science of this field. The Journal aims to ensure that hernia surgery is safer and easier for surgeons as well as patients, and provides a forum to all surgeons in the exchange of new ideas, results, and important research that is the basis of professional activity.
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