PREBIOUS trial: A multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: Rationale and design

Contemporary Clinical Trials 39 (2014) 335–341

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PREBIOUS trial: A multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: Rationale and design Manuel López-Cano a,g,⁎, José A. Pereira b, Roberto Lozoya c, Xavier Feliu d, Rafael Villalobos e, Salvador Navarro f, Maria Antonia Arbós g, Manuel Armengol-Carrasco a,g a

Unidad de Cirugía de la Pared Abdominal, Servicio de Cirugía General y Digestiva, Hospital Universitario Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain Servicio de Cirugía General y Digestiva, Hospital del Mar, Parc de Salut Mar, Departamento de Ciencias Experimentales y de la Salud, Universitat Pompeu Fabra, Barcelona, Spain c Servicio de Cirugía General y Digestiva, Hospital de Sagunto, Sagunto, Valencia, Spain d Servicio de Cirugía General y Digestiva, Hospital de Igualada, Igualada, Barcelona, Spain e Servicio de Cirugía General y Digestiva, Hospital Universitari Arnau de Vilanova, Universitat de Lleida, Lleida, Spain f Servicio de Cirugía General y Digestiva, Hospital Universitari Parc Tauli, Universitat Autònoma de Barcelona, Sabadell, Barcelona, Spain g Vall d'Hebron Research Institute General and Gastrointestinal Surgery Research Group, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain b

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Article history: Received 9 August 2014 Received in revised form 24 October 2014 Accepted 26 October 2014 Available online 1 November 2014 Keywords: Incisional hernia Prevention Midline laparotomy Prosthetic absorbable mesh Wound closure

a b s t r a c t Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which is to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months. Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair. © 2014 Elsevier Inc. All rights reserved.

⁎ Corresponding author at: Passeig Vall d’Hebron 119-129, E-08035 Barcelona, Spain. Tel.: +34 93 2746000x6587; fax: +34 93 2746224. E-mail addresses: [email protected] (M. López-Cano), [email protected] (J.A. Pereira), [email protected] (R. Lozoya), [email protected] (X. Feliu), [email protected] (R. Villalobos), [email protected] (S. Navarro), [email protected] (M.A. Arbós), [email protected] (M. Armengol-Carrasco).

http://dx.doi.org/10.1016/j.cct.2014.10.009 1551-7144/© 2014 Elsevier Inc. All rights reserved.

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1. Introduction A median surgical incision through the linea alba is the preferred approach to the majority of open abdominal operations (elective and/or urgent) because of its ease, speed, and visceral exposure that it provides. However, the decision about the incision still remains the preference of the surgeon usually according to the patient's disease and anatomy [1]. Incisional hernias are a well known complication of abdominal wall incisions but the rates of incisional hernias do not differ between midline or transverse (or oblique) approaches [1,2]. Despite technical [3] and fundamental biological advances [4–6], an effective method for preventing the development of this complication is lacking and incisional hernia repair continues to be a challenging procedure [7,8]. Moreover, many repaired incisional hernias recur and require new surgical repair, which may be difficult and risky in patients with added comorbidities [9]. Patient and technical related risk factors for the development of an incisional hernia are not clearly defined [6,10]. Some studies have evaluated the benefits of reinforcing the linea alba in a prophylactic manner with prostheses in high-risk patients. These studies have used permanent synthetic [11–16], biological [17], or absorbable [18] meshes placed in an onlay, sublay, or inlay fashion. Also, a new device (made of polypropylene and expanded polytetrafluoroethylene in the shape of an upside-down T) has been specifically designed to be placed between the two edges of the incision site to buttress the linea alba [19]. Recently, systematic reviews and meta-analyses have shown that these preventive measures may contribute to minimizing the rates of incisional hernia in high-risk patients [20–22]. Long-term potential complications (such as hernia recurrence, enterocutaneous fistula, bowel obstruction, infection, or chronic pain triggered in the host) related to these everlasting materials have been reported [12,14,23–27]. Therefore, an attractive hypothesis for improving the prevention of incisional hernia is the use of a bioabsorbable material so that after the implantation the scaffold is gradually degraded by the body, leaving behind no synthetic material while its function is taken over by newly generated tissue. In a previous experimental study carried out by our group [28], host tissue reaction was evaluated ex vivo after inserting a commercially available mesh of synthetic bioabsorbable polymers (polyglycolic acid-trimethylene carbonate) along the linea alba (“sandwich” method between the edges of the incision) at the time of closure of a midline laparotomy incision and compared with suture-only-treated rats. Meshtreated samples showed improved tissue ingrowth and better biomechanical behavior. The mechanisms included enhanced cell recruitment and enhanced extracellular matrix (ECM) deposition as well as remodeling and increased neovascularization. These results support the clinical potential of using a bioabsorbable mesh for reinforcing abdominal wall closure and preventing incisional hernia after midline laparotomy incision. Preliminary data provided by this study in a rat model provided the theoretical framework to design a randomized controlled study in patients undergoing open abdominal surgical operations through a midline laparotomy incision. It was hypothesized that insertion of a bioabsorbable synthetic mesh (GORE® BIO-A® Tissue Reinforcement prosthesis) in the incision line of the linea alba at the time of closure of

a midline laparotomy incision in non-selected patients undergoing abdominal operation is effective in the prevention of secondary incisional hernia within 6 months after operation. 2. Materials and methods: study design 2.1. Overall design A multicenter, prospective, randomized controlled, parallel, and single-blind trial was designed. 2.2. Study objectives The aim of the study was to determine if incisional hernia is prevented by prophylactic placement during open surgery of a bioabsorbable synthetic mesh to reinforce the suture at the time of closure of a midline laparotomy incision. Patients are blinded and are not aware if mesh placement did occur. Double blinding could not be guaranteed because most surgeons will see their own patients postoperatively in the outpatient clinic for follow-up visits. However, after the pilot phase of the study, mechanisms to involve independent masked clinicians to perform the clinical assessments will be implemented to correct the bias of a single-blind study. 2.3. Primary endpoint The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and sutureonly groups. Because the appearance of an incisional hernia occurs within the first months after laparotomy [29], assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of an incisional hernia was evaluated clinically and radiologically by physical examination at scheduled clinical visits and by an abdominal CT scan performed at the end of follow-up (6 months after operation). None of the two assessments (physical examination, CT scan) was the decisive examination. 2.4. Secondary endpoints Secondary endpoints are perioperative complications, including wound infection, hematoma, burst abdomen, pain and reoperation. 2.5. Setting Patients undergoing open abdominal procedures in an elective or urgent setting will be recruited from the following six centers: Hospital Universitari Vall d'Hebron (trial coordinator); Hospital de Sagunto, Sagunto, Valencia; Hospital Universitari Arnau de Vilanova, Lleida; Hospital de Igualada, Igualada, Barcelona; Hospital Parc Taulí, Sabadell, Barcelona; and Hospital del Mar, Barcelona, Spain. 2.6. Eligibility criteria Eligible patients are adults aged 18 years or older, who signed informed consent, and undergoing elective or urgent open abdominal surgical procedures regardless of benign or malignant disease. Participants are excluded from the study

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sample if they had a recurrent incisional hernia or an expected survival b12 months. 3. Recruitment, enrollment and randomization Non-selected eligible patients consecutively recruited at the participating hospitals undergoing elective or urgent open abdominal operations through a midline laparotomy incision are randomly assigned to an intervention group or to a control group. The abdominal wall is closed in the intervention group using a continuous polydioxanone (PDS) suture in the same way it is used in the control group except for insertion of the GORE® BIO-A® prosthesis. In patients assigned to the intervention group, closure of the midline laparotomy incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA) mesh. The BIO-A® prosthesis is inserted using a “sandwich” method between the edges of the incision and maintained in situ with the continuous 1.0 PDS single layer suture following a suture length to wound length (SL:WL) ratio of 4:1. This synthetic product is composed of a [co]polymer (polyglycolic acid:trimethylene carbonate [PGA:TMC]) that is gradually absorbed by the body. The device has a three-dimensional matrix consisting of open, interconnected pores. Like ECM, the matrix serves as a scaffold for tissue regeneration, but consists of polymer fibers instead of decellularized tissue. After implantation, the bioabsorbable material undergoes hydrolytic degradation over a period of about 6 months, leaving behind no synthetic material that could cause later complications. The PGA:TMC also encourages the development of vascularized tissue, a well-known effect of implanted porous materials. As a result, the polymer scaffold is replaced by a layer of new tissue that reinforces the midline suture fascial closure. The technique described in detail has been made available to all surgical units involved in the study. Moreover, homogenization of the surgical procedure among the different centers is made by a demonstration video of the surgical technique carried out by the principal investigator (ML-C) (Annex). In patients assigned to the control group, continuous 1.0 PDS single layer suture following a SL:WL ratio of 4:1 was only used for midline laparotomy closure. Randomization will be performed by an independent person using a computed-generated randomization list. Treatment will be stratified and blocked by center to ensure that each center has similar numbers of patients allocated to one of the two treatment groups. 4. Ethical considerations This trial is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines. It is approved by the Ethics Committee of Hospital Universitari Vall d'Hebron (PR [AG] 220/2013). All local Ethics Committees of the participating centers approved the final protocol. Patients willing to participate in the trial will be provided with a patient information sheet. They will be included after written informed consent is obtained. The PREBIOUS trial has been registered at ClinicalTrials. gov [NCT02208557].

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5. Measurements, data collection and management The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) and radiologically by an abdominal CT scan performed at 6 months (end of follow-up). Clinically, an incisional hernia was defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver. Radiologically, an incisional hernia was defined by a solution of continuity of the linea alba seen in the abdominal CT scan with the patient at rest or during the Valsalva maneuver, with or without protrusion of the abdominal content. The radiologist is blinded to the patient's history and the technique used for midline fascial closure. All data will be collected using a web-based platform (See http://www.bio-a.es) specifically designed for the study, with an independent username and password for each center. Rigorous and continued quality control to ensure accuracy of data will be established. At each center, a person responsible for data entry will be designated, with data access restriction limited to his/her own center. The study coordinator (ML-C) will have access to all data in the database. Database encryption will be implemented. This website is governed by the legal provisions applying exclusively to Spain and data gathering and processing of the data gathered will be done in compliance with Spanish Law 15/1999 of December 13 on the Protection of Personal Data. The case report form includes the following variables: a) preoperative data, including identification number (number of the patient's medical history), age, sex, height (in cm), weight (in kg), body mass index (BMI, in kg/m2), current smoker (yes/no), ex-smoker (yes/no), American Society of Anesthesiologists (ASA) physical status (I, II, III, IV), diabetes mellitus (yes/no), history of other hernias (yes/no), prostatism (yes/no), constipation (yes/no), chronic obstructive pulmonary disease (COPD) (yes/no), heart disease (yes/no), use of systemic corticosteroids (yes/no), use of immunosuppressant agents (yes/no), aortic aneurysm (yes/no), relaparotomy surgery (yes/no), and type of previous laparotomy; b) intraoperative variables (related to midline laparotomy), including date of surgery, elective or urgent operation, type of surgery (colon, esophagus, stomach, small bowel, other), length of linea alba incision (in cm), insertion of the BIO-A® mesh (yes/no), type of suture material (absorbable, non-absorbable, other), SL: WL ratio calculation with the formula (A − [B + C] / D) where A is original length of the suture (in cm), B is the length of suture remnants at the starting knot (in cm), C is the length of suture remnants at the finishing knot (in cm), and D is the length of linea alba incision [30], abdominal wall closure (surgeon-resident, surgeon-surgeon, resident-surgeon, resident-resident), type of surgery (clean, clean-contaminated, contaminated, dirty), antibiotic treatment (yes/no, type of antibiotic agent), retention measures (yes/no, which type), and time of laparotomy incision closure (in minutes); c) early postoperative data, including wound infection (yes/no), wound hematoma (yes/no), burst abdomen (yes/no), postoperative use of corticosteroids (yes/no), complications (yes/no, type of complication), reoperation (yes/no, reason for), and intensity of wound pain according to a 10-cm visual analog scale (VAS) completed by the patient on the first and third postoperative days and at hospital discharge; d) follow-up

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data at 3 months, including date of the outpatient visit, physical examination (evidence, suspicion, absence of incisional hernia), wound-related problems, and wound pain (VAS score); and follow-up data at 6 months (end of the study), including assessment of incisional hernia on physical examination and abdominal CT scan as well as abnormalities in the scar (yes/no, type of finding). Data collection schedule is shown in Table 1. Wound infection (deep or superficial) was defined according to the criteria of the Centers for Disease Control [31]. Hematoma was defined as a collection of blood in the wound area that needs to be drained or drains spontaneously. Burst abdomen was defined as an unintended opening (partial or complete) of the midline laparotomy wound with or without protrusion of omentum and/or intestine, with or without covering by the skin in the first 2 weeks after surgery.

6. Sample size calculation and analysis The sample size for this study was determined based on the primary endpoint: “appearance of an incisional hernia”. It is estimated that this complication develops in approximately 20% of cases after conventional suture only and that the insertion of the BIO-A® mesh may reduce the incidence of incisional hernia to 10%. For a chi-square test for the comparison of proportions, with an 80% statistical power and an alpha risk of 0.05, 244 patients in each arm will be needed to detect a 10% difference as statistically significant, accounting for a maximum of 20% attrition rate. A descriptive analysis of the sample will be presented, with frequencies and percentages for categorical variables, and mean and standard deviation (SD) or median and interquartile range (IQR) (25th-75th percentile) for continuous variables

Table 1 Data collection schedule. Variables

Preoperative

Identification patient number Demographics Height Weight Body mass index Smoking habit ASA physical status History of hernia Comorbidity Diabetes mellitus Prostatism Constipation COPD Heart disease Aortic aneurysm Use corticosteroids Use immunosuppressants Previous laparotomy Type of laparotomy Date of surgery Elective or urgent surgery Type of surgery Size and length of incision Insertion of the BIO-A® mesh Type of suture material Suture length to wound length ration calculation (A − [B + C] / D)a Abdominal wall closure Type of surgery Antibiotic treatment Retention measures Duration of incision closure Wound infection Wound hematoma Eventration Use of corticosteroids Complications Reoperation Wound pain (VAS score)b Date of the outpatient visits Hernia on physical examination Wound-related problems Wound pain (VAS score) Hernia on abdominal CT scan

X X X X X X X

At surgery

Postoperative (within 10 days)

3 months

6 months

X X X X

X X X X X

X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

COPD: chronic obstructive pulmonary disease. a A: original length of the suture (in cm), B: length of suture remnants at the starting knot (in cm), C: length of suture remnants at the finishing knot (in cm), and D: length of linea alba incision. b At 1 to 3 days after surgery, and at the time of hospital discharge.

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according to normal or non-normal distribution of data based on the Kolmogorov-Smirnov test and the Q-Q graphic test. Variables in the two study groups will be compared using the appropriate tests depending on the nature of each variable, including the chi-square (χ2) test or Fisher's exact test for categorical variables, and Student’s t test for independent samples or the Mann–Whitney U test. If considered necessary, multivariate analysis will be performed to assess variables independently associated with the appearance of an incisional hernia (dependent variable). Statistical significance is set at P b 0.05. The R-project for statistical computing will be used for generation of the randomization list and for the analysis of data. An overview of the trial is shown in Fig. 1. 7. Trial status The PREBIOUS trial is currently open for recruitment. We expect to reach our powered number of included patients in the coming months. All results will be reported according to the CONSORT 2010 statement (http://www.consort-statement.org/). 8. Discussion Incisional hernias are very common. Approximately 4 million laparotomies are performed in the United States annually, 2%-30% of them resulting in incisional hernia [32]. In non-selected patients, an incidence of 20% of incisional hernia after midline laparotomy during the first year after surgery has been reported [31], with higher rates if long-term follow-ups and high-risk patients are considered [32,33]. A recent analysis of 775 patients included in two clinical trials showed that the rate of incisional hernia increased significantly from 12.6% at 1 year to 22.4% 3 years after surgery [34]. Incisional hernias after laparotomy are mostly related to failure of the fascia to heal and involve technical and biological factors [35]. There is abundant evidence of treatment modalities and outcome of incisional hernia repair once a hernia has been developed [36–40] but data regarding protection against incisional hernia by the prophylactic prosthetic reinforcement of midline abdominal incisions is scarce and particularly focused on high-risk patients and permanent synthetic materials placed

Fig. 1. Study design.

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similarly as an incisional hernia is repaired (onlay, sublay, etc.) [20–22]. To perform a midline laparotomy, the linea alba (a midline raphe formed by the interweaving of the aponeuroses of the anterolateral abdominal muscles) has to be opened, and this area is a weak anatomic zone of the anterior abdominal wall. This weakness increases when its intersecting obliquetransverse fibers are sectioned, as occurs in midline laparotomies. In addition, when the midline laparotomy incision is closed, a certain amount of tension is generated between the wound edges because the abdominal wall is a continuously moving musculoaponeurotic structure where the linea alba plays an essential role to stabilize the mechanical forces (stresses and strains) acting on this system [41]. This tension is the combined result of two types of biomechanical forces: intraabdominal pressure and the abdominal muscular component (rectus and oblique muscles), which try to separate the wound edges. All these factors contribute to development of incisional hernia in this type of laparotomy, and highlight the need for new ways of closing the abdominal wall efficiently and also diminishing the incidence of postoperative herniation processes [19]. The use of a biomaterial to reinforce a laparotomy closure seems a simple and effective manner to prevent incisional hernia. The novel features of the PREBIOUS trial are the following: 1) a randomized design comparing systematic insertion of a bioabsorbable mesh along the linea alba (using a “sandwich” method between the edges of the incision) with suture only for closure of a midline laparotomy incision in unselected patients undergoing open abdominal procedures, 2) use of the bioabsorbable mesh with prophylactic purposes, 3) previous experimental data supporting stimulation of new tissue ingrowth with slow disappearance of the device and better biomechanical behavior [28], and 4) use of CT scan for assessing incisional hernia formation that may have gone unnoticed by physical examination only. By preventing the appearance of incisional hernia, the PREBIOUS trial has also the potential to save costs potentially associated with incisional hernia surgical repair and to avoid the effects on patients affected, such as poor cosmesis, social embarrassment, or impaired quality of life. It may be argued if the cost or the irradiation could be justified after using a CT scan in the follow-up. An incisional hernia was defined radiologically by a “solution of continuity of the linea alba” seen on the abdominal CT scan with the patient at rest or during the Valsalva maneuver, with or without protrusion of the abdominal content. This definition was accepted given that most incisional hernias appear during the first 3 months after a laparotomy incision [29] presumably with a very small size of defect or which may be occult (interstitial) incisional hernias, even in many cases in asymptomatic patients. For this reason CT was chosen as an objective diagnostic study that allows optimal visualization of the linea alba, including small or occult defects. The use of abdominal CT was approved by the Ethics Committees of the participating centers. Ultrasound was not selected because assessment of the abdominal wall contour is more difficult, interpretation of ultrasound findings is more subjective and dependent on the examiner especially in small or occult defects, and needs previous training. On the other hand, it may be expected that an important percentage of patients included in the study will have an abdominal neoplasm in which CT assessment at

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6 months of surgery will be mandatory in the control of the oncologic disease. Also, in a previous study of our group of parastomal hernia, the same radiological definition was used in CT scans performed after 12 months of surgery in rectal cancer patients undergoing elective laparoscopic abdominoperineal resection with permanent colostomy [42]. Comparative data of the diagnostic accuracy of abdominal ultrasound and CT scan for the assessment of incisional hernia after midline laparotomy is scarce. In the ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure, a hernia was diagnosed if the ultrasound showed a fascial gap or a protruding sac confirmed by physical examination. The ultrasound examination was carried out by an investigator who had at least 6 months training in this method [43]. In a study of the effectiveness of dynamic abdominal sonography for hernia (DASH) vs. CT, DASH was found to be an accurate alternative for diagnosis of abdominal wall hernias but DASH was performed with prerequisite training in the American College of Surgeons Ultrasound for Surgeons Basic Course [44]. In a recent study, DASH and CT showed similar results to characterize incisional hernia by measurement of mean surface but in this study all patients had incisional hernia on enrollment [45]. In the experience of other authors, abdominal CT is useful in the diagnosis of occult incisional hernias [46], particularly multi-detector row CT because it provides exquisite anatomic detail of the abdominal wall [47] The diagnostic accuracy of CT was also significantly higher than that of physical examination in the detection of hernia relapse within a year of operation of symptomatic patients who have been operated on for an intraperitoneal hernioplasty with unabsorbable mesh [48]. A limitation of the PREBIOUS trial is the follow-up limited to 6 months after surgery. The study evaluates within the first 6 months postoperatively whether a technical factor of placing a bioabsorbable mesh for routine midline laparotomy closure may improve the characteristics of the linea alba (as already shown in a previous experimental study [28]) that may contribute to reducing the occurrence of incisional hernia at the time when most incisional hernias develop. The long-term benefits of the intervention should be assessed extending the follow-up at least to 12 months and for this reason, results of the trial are not applicable out of the time framework of the study. Whether the hypothesized advantages of prophylactic insertion of the bioabsorbable mesh also apply to the laparoscopic approach needs to be addressed in future studies. Author contributions ML-C was the trial coordinator and drafted the manuscript. All authors contributed to the design and development of the trial protocol. All authors approved the study and this manuscript. Acknowledgments The trial is an investigator-initiated study supported in part by W.L. Gore and Associates, S.L., (PR(AG)220/2013) without scientific influence. The authors thank Marta Pulido, MD, for editing the manuscript and editorial assistance.

Appendix A. Supplementary data Supplementary data to this article can be found online at http://dx.doi.org/10.1016/j.cct.2014.10.009.

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