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Incidence and Risk Factors for Trocar-Site Incisional Ciscar et al. BMC Surg (2020) 20:330 https://doi.org/10.1186/s12893-020-01000-6 RESEARCH ARTICLE Open Access Incidence and risk factors for trocar-site incisional hernia detected by clinical and ultrasound examination: a prospective observational study Ana Ciscar1* , Josep M. Badia2,3 , Francesc Novell4, Santiago Bolívar5 and Esther Mans1,6 Abstract Background: Trocar site incisional hernia (TSIH) is the most frequent complication associated with laparoscopic surgery. Few studies currently describe its incidence or risk factors. The aim of this report is to determine the real inci- dence of TSIH and to identify risk factors. Methods: A cross-sectional prospective study was performed including consecutive patients who underwent a laparoscopic procedure during a 4 months period. All the patients were assessed both clinically (TSIHc) and by an ultrasonographic examination (TSIHu). The main variable studied was the incidence of TSIH. A multivariate analysis was performed to identify risk factors. Results: 76 patients were included. 27.6% of patients were clinically diagnosed as having TSIH (TSIHc) but only 23.7% of those cases were radiologically confrmed (TSIHu). In the logistic regression analysis, age > 70 years (OR 3.462 CI 1.14–10.515, p 0.028) and body mass index (BMI) 30 kg/m2 (OR 3.313 CI 1.037–10.588, p 0.043) were identifed as risk factors for= TSIH. The size of the trocar also showed≥ statistically signifcant diferences (p= < 0.001). Mean follow-up time was 34 months. Conclusions: TSIH is under-diagnosed due to the lack of related symptomatology and the inadequacy of the postop- erative follow-up period. We detected discrepancies between the clinical and ultrasonographic examinations. TSIHu should be considered as the gold standard for the diagnosis of TSIH. Risk factors such as age, BMI and size of the trocar were confrmed. Patients should be followed-up for a minimum of 2 years. Trial registration The study has been retrospectively registered in Clinicaltrials.gov on June 4, 2020 under registration number: NCT04410744 Keywords: Trocar site incisional hernia, Laparoscopic surgery, Risk factors, Incidence Background Incisional hernia is the most common complication asso- ciated with surgical procedures, with an estimated inci- dence of 0–35% [1, 2]. As there are few studies with a long-term follow up and the occurrence of the incisional *Correspondence: [email protected] hernia depends on the duration of postoperative follow- 1 Department of Surgery, Hospital de Mataró, Carretera de Cirera, 230, 08304 Mataró, Barcelona, Spain up, this estimate may not be accurate. Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creat iveco mmons .org/licen ses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creat iveco mmons .org/publi cdoma in/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Ciscar et al. BMC Surg (2020) 20:330 Page 2 of 7 Tere is a considerable amount of documentation 18 years, previous umbilical hernia repair, or failure to regarding incisional hernia after laparotomy, and several attend the postoperative appointment. risk and protective factors have been described. Despite the introduction of laparoscopic surgery, incisional her- Procedures nia is still frequent and, indeed, trocar site incisional her- In all patients, the umbilical trocar wound was closed nia (TSIH) is a common complication after laparoscopy. with an interrupted suture with synthetic braided Until recently, even in studies with a long term follow- ® ® absorbable 2/0 suture (Novosyn or Safl ). During the up, unrealistic TSIH rates of 0.8–2.9% [3–6] have been postoperative outpatient visit, informed consent was described. obtained and clinical and ultrasonographic examinations TSIH can be diagnosed by clinical examination, but were performed. To increase study homogeneity, a single imaging tests as computerized tomography (CT) or surgeon performed all clinical examinations and all ultra- dynamic abdominal sonography for hernia (DASH) can sound examinations were performed by a radiology med- improve the diagnostic accuracy. At present, a CT scan ical trainee closely supervised by the same abdominal is considered the gold standard technique for the diagno- radiology consultant. Sonography was performed using sis and characterization of TSIH, but it has a few draw- an Applio 500 equipment (Toshiba, Japan) with a 7 MHz backs: economic cost, patient irradiation, and that it is linear probe. Te ultrasound diagnosis was based on the a static procedure (which can under-diagnose). On the identifcation of an abdominal wall defect with intraab- other hand, dynamic abdominal sonography for hernia dominal tissue protrusion. Caudal and cranial diameters (DASH) has been shown to be a valid alternative to CT of the abdominal wall’s defect were recorded. Patients in the diagnosis and characterization of incisional hernia- diagnosed with TSIH were ofered elective repair. tion [7, 8]. One of the key factors for proper detection of the TSIH is the postoperative follow-up time. A short or incom- Measurements and variables plete follow up could underdiagnose this issue, which is Te main variables of the study were clinical (TSIHc) and often subclinical [7]. ultrasound (TSIHu) diagnosis of incisional hernia. Sec- Te aim of this study was to determine the incidence ondary variables analysed were age, sex, diabetes mel- of trocar-site incisional hernia (TSIH) by clinical and litus, chronic obstructive pulmonary disease (COPD), dynamic ultrasonographic examination in patients who smoking, body mass index (BMI), previous untreated underwent laparoscopic surgeries in a general hospital. umbilical hernia, malignancy, surgical time, urgent/elec- Secondary outcomes were to evaluate the correlation tive indication, incision size, degree of contamination between clinical and ultrasonographic assessment and to and surgeon’s experience. determine the main risk factors for TSIH. Statistical analysis Methods All results and variables were entered into a specifcally Study design designed database (File MakerPro 11.0v3 © 1984–2011 A single-centre cross-sectional study based on prospec- FileMaker, Inc.). Data were collected from clinical inter- tive clinical and radiological assessment and retrospec- views, physical and radiological examinations and the tive risk factor analyses performed at a single hospital. electronic medical record. Continuous variables were Te study has been retrospectively registered in Clini- described as means and standard deviations and cat- caltrials.gov on June 4, 2020 under registration number: egorical variables were described as absolute numbers NCT04410744. and percentages. Te Chi-square test was used to com- pare categorical variables (Fisher’s exact test was used Patients when needed), and the Student t-test was used to com- All consecutive patients undergoing laparoscopic surgery pare continuous variables. Bivariate analysis and mul- (cholecystectomy, colon resection, adrenalectomy, Nis- tivariate logistic regression analysis were performed to sen fundoplication and appendectomy) during a 4-month identify independent predictive causal factors for the period were included in the study. 30 months after hos- development of TSIH. Adjusted odds ratios (ORs) were pital discharge, they were invited by telephone to par- calculated using logistic regression. Variables achiev- ticipate in the study. Detailed project information was ing statistical signifcance in the bivariate analysis were provided, and those who accepted received an appoint- considered for multivariate analysis. ORs with 95% con- ment for an outpatient visit and a dynamic ultrasound fdence intervals (CIs) were presented for each studied examination. A written informed consent was obtained variable. Diferences were signifcant at the 5% level. All from all participants. Exclusion criteria were age under reported p values were two-sided. Statistical analyses Ciscar et al. BMC Surg (2020) 20:330 Page 3 of 7 were performed using SPSS statistical software (IBM Table 1 Main patient characteristics ® SPSS Statistics). N 76 Age years (SD) 58.47 (16.58) Results 70 n (%) 54 (71.1) ≤ A total of 120 patients, who were operated on, were > 70 22 (28.9) contacted and 76 of them were fnally included in the Gender n (%) study (Fig. 1). 57.9% were women, and the mean age Male 32 (41.1) was 58.5 years. Among them, 13.2% were diabetic, 5.4% Female 44 (57.9) had chronic obstructive pulmonary disease (COPD), DM n (%) 2 27.5% were obese (BMI over 30 kg/m ) and 11.8% had a Yes 10 (13.2) malignancy. Te primary laparoscopic procedures were Not 66 (86.8) cholecystectomy (78.9%), sigmoidectomy (10.5%), Nis- COPD n (%) sen fundoplication (7.9%), adrenalectomy (1.3%) and Yes 4 (5.4) appendectomy (1.3%). Mean postoperative follow-up was Not 70 (94.6) 34 months (Table 1). Smokers n (%) Yes 19 (27.1) TSIH incidence Not 51 (72.9) Of the 76 patients included in the study, a total of 303 BMI kg/m2 (SD) 27.54 (4.25) trocar site incisions (TSI) were assessed (151 of 10 mm- 30 n (%) 19 (27.5) TSI and 152 of 5 mm-TSI). A total of 21 patients (27.6%) ≥ < 30 50 (72.5) were clinically diagnosed with having TSIH (TSIHc).
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