VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER SURGERY. PROSPECTIVE AND MULTICENTRIC STUDY
Conditions: Surgical Hemorrhage, Liver Cancer, Liver Metastases
Sponsor: Hospital Miguel Servet

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TITLE: 
VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE 
IN LIVER SURGERY. 
PROSPECTIVE AND MULTICENTER STUDY 
 
PROMOTER: 
 Institute for Health Research Aragón 
 
RESEARCH TEAM: 
Principal investigators: 
 
Mario Serradilla Martin 
Institute for Health Research Aragón 
Division of Hepato-Pancreato-Biliary Surgery 
Department of Surgery 
Miguel Servet University Hospital 
Paseo Isabel La Católica, 1-3 
50009 Zaragoza (Spain) 
 
Daniel Aparicio López 
Department of Surgery 
Miguel Servet University Hospital 
Paseo Isabel La Católica, 1-3 
50009 Zaragoza (Spain) 
 
 
 
 
Jose Manuel Ramia Angel 
Head, Department of Surgery 
Alicante General University Hospital 
Painter Baeza, 11 
03010 Alicante (Spain) 
 
 

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Research collaborators: 
Attached in ANNEX I. 
 
Correspondence: 
 
Mario Serradilla Martin 
Division of Hepato-Pancreato-Biliary Surgery 
Department of Surgery 
Miguel Servet University Hospital 
Paseo Isabel La Católica, 1-3 
50009 Zaragoza (Spain) 
email: marioserradilla@hotmail.com / mserradilla@salud.aragon.es 
 
Study design: Mario Serradilla Martín, José Manuel Ramia Ángel. 
Study protocol: Daniel Aparicio López, Mario Serradilla Martín, José Manuel 
Ramia Ángel. 
Data collection notebook: Daniel Aparicio López, Mario Serradilla Martín, José 
Manuel Ramia Ángel. 
 
 
 
 
 
 
 
 
 
 
 
 

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Prospective multicenter study, supported by the Hepato-Pancreato-Biliary Surgery 
Division of the Spanish Association of Surgeons (AEC) and the Spanish Chapter of 
the International Association of Hepato-Pancreato-Biliary Surgery (IHPBA). 
 
LIST OF ABBREVIATIONS 
 
AEC 
 
Spanish Association of Surgeons 
  
CCI 
 
Comprehensive Complication Index 
 
CEICA  
Research Ethics Committee of Aragon 
 
FDA 
 
Food and Drug Administration 
 
GCP 
 
Good Clinical Practices 
 
IHPBA 
International Association of Hepato-Pancreato-Biliary Surgery 
 
ISGLS  
International Study Group of Liver Surgery 
 
JCR 
 
Journal Citation Reports 
 
VIBe  
Validated Intraoperative Bleeding Scale 
 
 
 
 
 
 
 
 
 
 
 
 

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INDEX 
Abstract 
 
 
 
 
 
 
 
 
 
5 
1. Background                             
 
 
 
 
 
7 
2. Hypothesis 
 
 
 
 
 
 
 
 
10 
3. Objetives 
 
 
 
 
 
 
 
 
11 
4. Methods 
 
 
 
 
 
 
 
 
11 
4.1. 
Patient and design 
 
 
 
 
 
             12 
4.2. 
Participating centers  
 
 
 
 
             12 
4.3. 
Follow-up  
  13 
4.4. 
Definitions 
 
 
 
 
 
 
             13 
4.5. 
Data record 
 
 
 
 
 
 
             13 
4.6. 
Sample size 
 
 
 
 
 
 
             14 
4.7. 
Statistical analysis 
 
 
 
 
 
             14 
5. Ethical aspects 
 
 
 
 
 
 
             15 
6. Authorshinp and publication policy 
 
 
 
             16 
7. Timeline 
 
 
 
 
 
 
 
             16 
8. Funding 
 
 
 
 
 
 
 
             17 
9. References 
 
 
 
 
 
 
 
             17 
10. Anexxes 
 
 
 
 
 
 
 
             21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABSTRACT 
 
Introduction. Surgical hemostasis has become one of the fundamental principles 
for the advancement of surgery. The use of hemostatic agents is standard in many 
surgical specialties, although the lack of consensus or standardized classifications 
to determine intraoperative bleeding has led to their inappropriate selection on 
many occasions. The recommendations of international organizations highlight the 
need for a bleeding severity scale validated in clinical studies that allows selecting 
the hemostatic agent that best suits each case. 
 
Objective. The primary objective is to validate the VIBe scale (Validated 
Intraoperative Bleeding Scale) in liver surgery. The secondary objectives are: to 
assess the repeatability, reproducibility and usefulness of the scale in this type of 
surgery, and determine the relationship between type of bleeding and hemostatic 
used. 
 
Methods. Prospective multicenter observational study including all liver 
resections performed in participating hospitals in the study period. The 
participating collaborating researchers will be responsible for collecting the data, 
as well as for communicating them to the study coordinators. 
 
Strengths. Medium / high volume Liver Surgery Units of Spain participate in this 
multicenter study, thus being able to recruit a large sample size, which will allow 
us to collect highly detailed, representative and reliable information on the results 
obtained. 
 
Need for the study. Despite the large number of liver resections performed 
annually, intraoperative hemostasis is performed using different topical 
hemostats. However, there is no validated scale that allows stratifying bleeding and 
selecting the hemostatic agent that best suits each clinical situation. 
 

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Limitations. The study is multicenter in nature, so there may be selection or 
information biases when dealing with centers with different criteria and surgical 
indications. The quality of the outcome measurement is limited by the possible 
heterogeneity between centers and the quantification of intraoperative bleeding. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. BACKGROUND 
 
 
Surgical hemostasis has become one of the fundamental principles for the 
advancement of surgery1. The use of hemostatic agents is standard in many 
surgical specialties2-6, with greater use in major surgeries7-8. Inadequate 
hemostasis significantly increases the risk of perioperative morbidity and 
mortality9-10, healthcare costs and the use of resources11-14. The need for 
hemostasis has led to the development of various topical hemostatic agents15-17. 
 
 
Clinical studies that have analyzed the use of topical hemostats have not 
used standardized definitions or classifications to determine the severity of 
intraoperative bleeding18-19, partly due to a lack of consensus on the definition of 
the severity of bleeding and partly due to the severity of bleeding. lack of 
requirements to do so. This has led many surgeons to an inadequate selection of 
hemostats for different bleeding situations, the results being inefficient8. Using 
standardized criteria, the results of clinical studies can be compared to determine 
the effectiveness of hemostatic agents. 
 
 
The FDA (Food and Drug Administration) requires the use of a bleeding 
severity scale validated in clinical studies investigating hemostatic agents. The 
VIBe (Validated Intraoperative Bleeding Scale) for intraoperative bleeding was 
developed in 201720. This scale has been validated by a large number of expert 
surgeons from all specialties, but in an animal model. However, it has not yet been 
clinically validated. 
 
 
Liver surgery is one of the surgeries where intraoperative bleeding is 
more important. In Spain, around 5000 liver resections are performed annually, 
not including liver transplants. It is, therefore, a perfect framework to validate the 
applicability of the VIBe scale of severity of intraoperative bleeding. 
 

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In order to evaluate the viability of a prospective clinical study in liver 
surgery, a parallel project has been worked on based on the evaluation of the 
applicability of the VIBe scale, carried out by liver surgeons by reviewing the 
original video recordings described in the VIBe scale28. Forty-seven surgeons were 
selected from 10 medium/high-volume liver surgery centers, all of them reference 
centers (same centers that will participate in the prospective study). 5 of the 10 
hospitals perform liver transplants. These centers have a mean reference 
population of 922,506 ± 225,603 patients. The mean number of major 
hepatectomies per year is 23 ± 16, the number of minor hepatectomies 56 ± 24, 
and the number of liver transplants 40 ± 27. 40.5% of all hepatectomies are 
performed by a minimally invasive approach. 
 
 
The 47 surgeons viewed 14 videos used by Lewis et al.20 for the validation 
of the original VIBe scale. 63.3% of the participating surgeons were men with a 
mean age of 41.6 years. 17% were unit / department heads and 83% were senior 
surgeons. The mean experience was 9.3 years, and the majority were experts 
(21.3%) or with advanced knowledge (53.2%) in minimally invasive surgery. Only 
23.4% had prior knowledge of the VIBe scale, but all surgeons used hemostats in 
their daily clinical practice. The VIBe scale achieved a mean intraobserver 
agreement of 0.985 and an interobserver agreement of 0.929, neither of which was 
influenced by the experience of the surgeon or the volume of surgeries per year. 
The average rating for all videos was 67% correct, in line with the original 
validation. Most surgeons considered that the scale represented the range of 
severity of bleeding in their procedures (91%), relevant to assess intraoperative 
hemostasis in clinical studies (96%) and clinical practice (87.2%), useful in CMI 
(96%), and also to differentiate hemostatic agents (81%). 
 
 
The data of the analysis are shown in Table 1. 
 
 
 

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Table 1. Correct score compared to the publication of Lewis et al. 2017 and interobserved 
agreement. 
 
 
With these preliminary data, based on the video classification exercise, we 
can conclude that the VIBe scale is useful for the assessment of the severity of 
bleeding performed by liver surgeons. Therefore, an assessment of the severity of 
intraoperative bleeding using the scale in actual liver surgery is feasible. Our goal 
is to publish these results independently before starting the clinical observation 
record. 
 
 
To evaluate the clinical applicability, a prospective registry of patients 
undergoing liver surgery has been designed in the 10 selected Spanish centers. 
Kendall's coefficient of 
agreement 
 
Degree of 
concordance 
Intra-observer agreement 
 
 
All surgeons (N=47) 
0.985 
Excellent 
Depending on the surgeon's experience 
     High experience (N=23) 
     Low experience (N=24) 
 
0.990 
0,981 
 
Excellent 
Excellent 
Depending on the number of surgeries/ 
year 
    High number (N=20) 
    Low number (N=27) 
 
 
0.995 
0.979 
 
 
Excellent 
Excellent 
Interobserver agreement 
  
  
All surgeons (N=47) 
0.929 
Excellent 
Depending on the surgeon's experience 
     High experience (N=23) 
     Low experience (N=24) 
 
0.941 
0.922 
 
Excellent 
Excellent 
Depending on the number of surgeries / 
year 
    High number (N=20) 
    Low number (N=27) 
 
 
0.940 
0.923 
 
 
Excellent 
Excellent 
A Kendall coefficient of 0.70 or more was considered evidence of a scoring system with appreciable agreement, a 
coefficient of 0.80 or more was considered good agreement, and a coefficient of 0.90 or more excellent agreement. 
. The median experience was 7 years: low experience was considered ≤ 7 years; It was considered high experience> 
7 years. The median number of surgeries per year was 35: a low number of surgeries ≤ 35 surgeries per year was 
considered; The number of surgeries> 35 surgeries per year was considered high. 

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Demographic and preoperative, intraoperative and postoperative data will be 
collected (ANNEX II). Intraoperative bleeding will be measured according to the 
VIBe scale at two points of the surgical intervention: the maximum bleeding and at 
the end of the surgery. Data will be collected on the type of hemostatic or surgical 
strategy that has been carried out to correct bleeding (i.e. pressure, suture, 
coagulation, hemostatic, etc.) and other data related to bleeding (blood loss, units 
of blood transfused, etc.). Postoperative complications will be classified according 
to the Clavien-Dindo classification and the CCI (Comprehensive Complication 
Index) (ANNEX III). Major complications are defined as those with a Clavien-Dindo 
≥ IIIa. The classification of liver failure and postoperative bleeding are defined 
following the International Study Group of Liver Liver Surgery (ISGLS) 
classifications (ANNEX III). An online database will be generated (CASTOR®, 
CIWIT BV, Amsterdam) and at the end of the registration a statistical analysis of 
the data will be performed to determine the applicability and usefulness of the VIBe 
scale in liver surgery, as well as to determine the relationship between the type of 
bleeding, the hemostatic measurements used, the success rate of the hemostatic 
measurements, and the bleeding-related complications. 
 
 
Despite the extensive literature published on liver surgery, there is no 
scientific evidence that allows us to have validated scalds that quantify the severity 
of intraoperative bleeding and, consequently, select which is the best hemostatic 
procedure that is adapted to each case. All of this has repercussions on patient 
safety, increased postoperative morbidity and mortality, as well as the 
inappropriate use of healthcare resources and consequently increased costs. 
 
 
This prospective multicenter study in national centers that perform Liver 
Surgery aims to evaluate and validate a scale that allows quantifying intraoperative 
bleeding in liver surgery. 
 
 
 

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2. HYPOTHESIS 
 
 
 
The VIBe scale for the severity of intraoperative bleeding has only been 
validated in an animal model since its inception. Liver surgery is a type of surgery 
where intraoperative bleeding occurs frequently and can have a major impact on 
the results. It is, therefore, a perfect framework to apply the VIBe scale for 
intraoperative bleeding in humans. 
 
3. OBJETIVES 
 
 Primary objective: to validate the VIBe scale for intraoperative bleeding in 
liver surgery. 
 
 Secondary objectives: 
 
Assess the repeatability, reproducibility and usefulness of the scale 
in this type of surgery. 
 
Determine the relationship between type of bleeding and hemostatic 
used, the success rate of hemostatic measurements, and 
complications related to bleeding. 
 
4. METHODS 
 
 
It is a prospective multicenter registry lasting 12 months (this period can be 
lengthened if the stipulated number of patients has not been reached) in which 10 
units of reference of HPB Surgery participate in Spain with medium/high volume 
of liver surgery . This registry includes all the elderly patients operated on in the 
participating Spanish centers who underwent liver surgery in the period 
described. The registry will remain open until the sample size is recruited for a 
further 4 months to include postoperative morbidity and mortality at 90 days. 
 

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The key point of the study is to determine the degree of intraoperative 
bleeding evaluated with the VIBe scale. Because bleeding episodes can be 
numerous during a hepatectomy, it is considered impossible to measure each 
bleeding individually. According to the collaborating researchers, it has been 
considered appropriate to assess it at two selected moments: the moment of 
greatest bleeding and at the end of the surgery. An intraoperative record sheet 
(ANNEX IV) will be prepared and completed according to the statements of the 
main or assistant surgeon and will be reviewed and finally signed by the main 
surgeon at the end of the procedure. In the same way, blood losses (amount of fluid 
in the suction container minus serum used for flushing), the units of blood 
transfused and the lowest hemoglobin value during admission (compared to 
baseline hemoglobin) will be quantified. ). The rest of the data will be collected at 
the time of discharge and 3 months after surgery. 
 
4.1. Patient and design 
 
 
 Inclusion criteria: patients scheduled for liver surgery, by open or 
minimally invasive approach, regardless of diagnosis; ASA score <4; age ≥ 
18; who have signed the informed consent. 
 
 Exclusion criteria: patients with contraindications for liver surgery; 
emergency surgical interventions; patients <18 years; patients who have 
not signed the informed consent. 
 
4. 2. Participating centers 
 
 
 
Ten national centers of moderate-high volume in liver surgery 
participated in this study, all of them reference centers, which participated in the 
first phase of the study with the visualization of the videos. The dissemination and 
knowledge of the study will be carried out through the HPB Surgery Section of the 

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Spanish Association of Surgeons (AEC), as well as the Spanish Chapter of the 
International Association of Hepato-Pancreato-Biliary Surgery (IHPBA). When 
confirming their participation, the participating centers will designate a contact 
person. 
 
 
4. 3. Follow-up time 
 
 
 
Classically, morbidity and mortality data are recorded in the immediate 
postoperative period (30 days). However, liver surgery is a type of surgery in 
which complications can occur beyond 30 days, so the international scientific 
community has agreed to record complications after 90 days. 
 
4.4. Definitions 
 
 
Patient comorbidities will be classified using the Charlson Comorbidity 
Index29. Postoperative complications will be classified using the Clavien-Dindo30 
Classification of Surgical Complications and the Comprehensive Complication 
Index (CCI)31. Major complications are those defined as Clavien-Dindo grade IIIa or 
higher. To collect complications, the medical and nursing notes of each electronic 
or physical record of each patient included in the project will be contrasted. For the 
specific complications of liver surgery, the definitions of the International Study 
Group of Liver Liver Surgery (ISGLS) of liver failure32 and postoperative bleeding33 
will be used. Complications, readmissions and mortality will be measured at 90 
postoperative days, through the medical history and, if necessary, by telephone 
communication with the patient or relatives (ANNEX III). 
 
4.5. Data record 
 

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Each participating center will designate a contact person, responsible for 
data collection, and all communication with the study coordinators. Subsequently, 
each contact person will receive a login code and passwords for the online 
electronic case report form (CRDe) environment (CASTOR®, CIWIT B.V., 
Amsterdam). Each data collector will receive a separate login account from which 
the lead study coordinators can monitor all activity. All data collection will be 
carried out in accordance with the Good Clinical Practice (GCP) guidelines. 
 
 
 
The variables collected in said form are shown in ANNEX II. 
 
 
4.6. Sample size 
 
 
 
Based on an estimated population size of 5000 liver surgeries per year in 
Spain, a sample size of 259 cases will be selected to achieve a margin of error of 5% 
with a confidence level of 90%. 
 
 
Based on the normal distribution, the sample size n and the margin of 
error E are given by: 
 
x = Z (c / 100) 2r (100-r) 
n = N x / ((N-1) E2 + x) 
E = Sqrt [(N - n) x / n (N-1)] 
 
 
Where N is the size of the population, r is the fraction of responses (set at 
50% as the most conservative assumption) and Z (c / 100) is the critical value for 
the confidence level c21. 
 
 
 

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4.7. Statistical analysis 
 
 
 
Depending on the number of cases contributed by each collaborating 
hospital, a retrospective analysis will be carried out to detect the power of the 
differences observed in the data. The variables of interest will be described in 
univariate and bivariate tables according to the study groups. For comparisons 
between groups, parametric (t-student, ANOVA) and non-parametric (Mann-
Whitney, Kruskal-Wallis) tests will be used in continuous variables depending on 
their distribution and Fisher or chi-square tests for categorical variables. 
 
 
To investigate the relationship between different variables, correlation 
analysis and / or linear regression and bi or multivariate logistic will be used. In 
addition, the longitudinal variation of certain variables of interest will be studied, 
for this, Kaplan-Meier estimators and bi or multivariate analysis using Cox models 
will be carried out. The analyzes will be carried out with the statistical software R. 
Statistical significance will be considered for values of p <0.05. 
 
5. ETHICAL ASPECTS 
 
- 
Risk / benefit balance. This is a prospective registry of patients undergoing 
liver surgery. It is a common procedure that does not require the performance 
of any extraordinary measure. 
- 
An insurance policy is not necessary to not carry out any invasive treatment. 
- 
Treatment of personal data. In accordance with the Organic Law on Personal 
Data Protection of December 6, 2018, in accordance with the General Data 
Protection Regulation, patients participating in the study will be adequately 
informed about the data to be collected and for what purpose. They will use 
the data, as well as the right of access, modification, opposition, cancellation, 
portability and limitation at all times. Those responsible for data treatment 
will have the necessary technical and organizational measures, in the terms 
derived from the regulations (articles 9.2.j), 89.1 and 32 RGPD), complying 

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with the requirements established in sections 2.d) , f) and g) of DA 17 of LO 
3/2018. 
At no time will identifying data of the patient be included in the study base and 
no one except the research team of each hospital will be able to access the 
identity of the patient. The data will be included in the environment of the 
electronic online case report form (CASTOR®, CIWIT B.V., Amsterdam), which 
complies with current European and American data protection regulations. All 
editing and audit trails will be logged in accordance with Good Clinical Practice 
(GCP) guidelines. 
- 
At no time does the study interfere with the care tasks of the center, does not 
increase the waiting lists or imply a distribution of resources that may affect 
the principle of justice. In no case will the usual practice be altered. 
- 
Each patient will be given the informed consent that they must sign to be 
included in the registry (ANNEX V). 
- 
This study has a purely observational design, so it will not carry out any type 
of intervention on the recruited individuals. The study will be carried out in 
accordance with the Declaration of Helsinki (last modification, Brazil, 2013) 
and current Spanish legislation (Ministerial Order SAS / 3470/2009, regarding 
the performance of observational studies and Law 14/2007, on biomedical 
research) . 
- 
This study will have the approval of the Research Ethics Committee of Aragon 
(CEICA). 
 
6. AUTHORSHINP AND PUBLICATION POLICY 
 
 
Authorship will be based on the guide of the International “Committee of 
medical Journal Editors” 34. The study coordinators will occupy the first and last 
positions of authorship (DAL, MSM and JMRA). All centers will have the right to 
include 3 authors in the publications generated by the study. The order will be 
determined by the number of cases contributed and if there is a tie of cases in 

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alphabetical order. The data obtained will be communicated to the CEIC 
Law14/2007 and published. 
 
 
The data generated by the study will be sent to journals with a contrasted 
impact factor indexed in the Journal Citation Reports (JCR). In the same way, they 
will be sent as communications to international conferences of reference of HPB 
Surgery (IHPBA/E-AHPBA congress/ESSO Congress). 
 
7. TIMELINE  
 
 
              
 
 
 
 
8. FUNDING  
 
 
 
 
 
              
 
 
This study has received the Investigator Initiated Research (IIR) grant from 
Baxter S.L. 
https://www.baxter.com/our-story/fueling-collaborative-innovation/research-
continuing-education-grants 
 
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complication index: a novel continuous scale to measure surgical morbidity. 
Ann Surg. 2013 Jul;258(1):1-7. 
32. Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R et 
al. Posthepatectomy liver failure: a definition and grading by the 
International 
Study 
Group 
of Liver Surgery 
(ISGLS). 
Surgery 
2011;149(5):713-24).  
33. Rahbari N, Garden J, Padbury R, Maddern G, Koch M, Hugh T, et al. Post-
hepatectomy haemorrhage: a definition and grading by the International 
Study Group of Liver Surgery (ISGLS). HPB. 2011; 13(8): 528-3. 
34. De Angelis C, Drazen JM, Frank A, Frizelle FA, Haug C, Hoey J,  et al. Clinical 
Trial Registration: A Statement from the International Committee of Medical 
Journal Editors N Engl J Med 2004;351:1250-1251. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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22 
 
 
 
 
 
10. ANEXXES              
 
ANNEX I. PARTICIPATING HOSPITALS AND MAIN RESEARCHERS OF EACH 
CENTER. 
 
HOSPITAL 
CITY 
PRINCIPAL RESEARCH 
POSITION 
Miguel Servet 
Zaragoza 
Mario Serradilla Martín 
Senior HPB surgeon 
General Universitario 
Alicante 
José Manuel Ramia Ángel 
Head of Service 
Virgen del Rocío 
Sevilla 
Miguel Ángel Gómez 
Bravo 
Head of HPB 
department 
La Princesa 
Madrid 
Elena Martín Pérez 
Head of Service 
Mutua de Tarrasa 
Tarrasa 
Esteban Cugat Andorrá 
Head of HPB 
department 
Germán Trias y Pujol 
Badalona 
Esteban Cugat Andorrá 
Head of HPB 
department 
Josep Trueta 
Girona 
Santiago López Ben 
Head of HPB 
department 
Complejo 
Universitario 
Badajoz 
Gerardo Blanco Fernández 
Head of Service 
Clínico Universitario 
Valencia 
Luis Sabater Ortí 
Head of HPB 
department 
Gregorio Marañón 
Madrid 
José Manuel Asencio 
Pascual 
Senior HPB surgeon 
 
 
 
 
 
 
 
 
 
 

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23 
 
 
 
 
 
 
 
ANNEX II. DATA COLLECTION NOTEBOOK. 
 
- 
Hospital. 
- 
Patient identification number. 
- 
Date of birth. 
- 
Sex: 
o Male. 
o Female.  
- 
Weight (kg). 
- 
 Height (m). 
- 
BMI (Kg / m2) 
- 
ASA: 
o I. 
o II. 
o III. 
o IV. 
- 
Charlson comorbidity index: 
o 
DM without target organ involvement. 
o 
Diabetes with target organ involvement. 
o 
Myocardial infarction. 
o 
Coronary heart disease. 
o 
Peripheral vascular disease. 
o 
Cerebrovascular disease. 
o 
Arterial hypertension. 

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24 
o 
Alcoholism. 
o 
Thromboembolic disease. 
o 
Arrhythmia. 
o 
Dementia. 
o 
COPD. 
o 
Connective tissue disease. 
o 
Peptic ulcer. 
o 
Mild liver disease (without portal hypertension, includes chronic 
hepatitis). 
o 
Hemiplegia. 
o 
Moderate-severe kidney disease. 
o 
Leukemia (acute or chronic). 
o 
Lymphoma. 
o 
Moderate or severe liver disease. 
o 
Solid tumor with metastasis. 
o 
AIDS (not just HIV positive). 
- 
Surgical history: 
o 
Cholecystectomy. 
o 
Hepatectomy. 
o 
Other supramesocolic surgery. 
o 
Inframesocolic surgery. 
o 
Others. 
o 
No 
- 
Underlying disease: 
o Liver metastasis from colorectal carcinoma 
o Liver metastasis from neuroendocrine tumor 
o Liver metastasis from no coloretal carcinoma or neuroendocrine 
tumor 
o Hepatocarcinoma. 
o Cholangiocarcinoma 
o Adenoma. 

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25 
o Focal nodular hiperplasia. 
o Others. 
- 
Affected liver segments (intraoperatively) 
o I. 
o II. 
o III. 
o IVa. 
o IVb. 
o V. 
o VI. 
o VII. 
o VIII. 
- 
Neoadjuvant chemotherapy 
o Yes. 
o No. 
- 
Time elapsed from diagnosis to start of treatment (days). 
- 
Date of surgery 
- 
Previous portal embolization: 
o Yes. 
o No. 
- 
Previous volumetry:  
o Yes 
o No. 
- 
Functional residual volume (cc) 
- 
Two-stage surgery:: 
o Yes. 
o No. 
- 
Reverse surgery: 
o Yes. 
o No. 
- 
Surgical approach: 

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26 
o Open (laparotomy) 
o Laparoscopy 
o Robotic 
o Conversion 
- 
Type of liver (macroscopic): 
o Normal. 
o Steatosis 
o Fibrosis 
o Chemotherapy-induced liver injury Cirrhosis 
- 
Type of surgery: 
o Left lateral sectionlectomy (2 and 3) 
o Bisegmentectomy (5 and 6) 
o Right anterior sectionlectomy (5 and 8) 
o Right posterior sectionlectomy (6 and 7) 
o Left hepatectomy (2, 3 and 4) 
o Right hematopathy (5, 6, 7 and 8) 
o Central hepatectomy (4, 5 and 8) 
o Extended right hepatectomy (4, 5, 6, 7 and 8) 
o Extended left hepatectomy (2, 3, 4, 5 and 8) 
o Atypical resection 1 
o Atypical resection 2 
o Atypical resection 3 
o Atypical resection 4a 
o Atypical resection 4b 
o Atypical resection 5 
o Atypical resection 6 
o Atypical resection 7 
o Atypical resection 8 
o Anatomical resection segment 1 
o Anatomical resection segment 2 
o Anatomical resection segment 3 

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27 
o Anatomical resection segment 4a 
o Anatomical resection segment 4b 
o Anatomical resection segment 5 
o Anatomical resection segment 6 
o Anatomical resection segment 7 
o Anatomical resection segment 8 
- 
Other associated procedures: 
o Radiofrequency 
o Microwave. 
o Atypical resection 
o Others 
- 
Operative time (min). 
- 
Bleeding (ml). 
- 
Units of blood transfused: 
- 
Type of bleeding (major intraoperative bleeding): 
o 
0: no bleeding (<1 mL / min). 
o 
1: mild (1-5 mL / min) 
o 
2: moderate (5-10 mL / min). 
o 
3: severe (10-50 mL / min). 
o 
4: very severe (> 50 mL / min). 
- 
Type of hemostasis performed: 
o 
Compression 
o 
Coagulation 
o 
Suture 
o 
Application of hemostatic agent 
o 
Name of hemostatic 
- 
Clamping time (min). 
- 
Complications: 
o Yes. 
o No. 
- 
Complications (Clavien-Dindo): 

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28 
o I 
o II 
o IIIa 
o IIIb 
o IVa 
o IVb 
o V 
- 
Comprenhensive Complication Index. 
- 
Hemorrhage 
o No. 
o A. 
o B. 
o C. 
- 
Liver failure  
o No. 
o Mild. 
o Moderate. 
o Severe. 
- 
Biliary fistula:  
o Yes. 
o No. 
- 
Bilioma: 
o Yes. 
o No. 
- 
Intra-abdominal collection:  
o Yes. 
o No. 
- 
Reintervention: 
o Yes. 
o No.  
- 
Type: 

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29 
o Percutaneous drainage. 
o ERCP. 
o Surgical reintervention. 
o Interventional X-ray 
- 
Medical complication:  
o Septic shock. 
o IAM. 
o Cardiac arrest. 
o DVT or pulmonar embolism. 
o ACV/AIT. 
o Others. 
- 
ICU stay (días). 
- 
Total stay (days): 
- 
Postoperative transfusión: 
o Yes. 
o No. 
- 
Units of blood:  
- 
Reentry: 
o Yes. 
o No. 
- 
Cause: 
- 
Hemoglobine: 
o Preoperative. 
o Lower during the hospital stay. 
- 
Need for IV or PO iron: 
o Yes. 
o No. 
- 
Follow-up at 3 months: 
- 
Free from disease: 
o Yes. 
o No. 

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30 
- 
Recurrence date: 
- 
Death: 
o Yes.  
o No. 
- 
Date of death or last visit. 
 
 
 
 
 
 
 
 

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31 
ANNEX III. CLASSIFICATIONS USED 
 
CLAVIEN-DINDO CLASSIFICATION OF SURGICAL COMPLICATIONS. 
Dindo D, Demartines N, Clavien P-A. Classification of surgical complications. Ann 
Surg. 2004;240:205–213.  
 
 
Suffix "d" 
If the patient suffers a complication at the time of discharge, the suffix “d” (for disability) is added 
to the degree of the complication (resection of the pancreatic remnant is included). This suffix 
indicates the need for follow-up to fully evaluate the complication. 
 
* Regarding RVG: The placement of a central line for TPN or nasojejunal tube by endoscopy in a 
grade IIIa complication. However, if the central line or nasojejunal tube has been placed during 
surgery, then TPN or enteral nutrition is a grade II complication. 
 
† Cerebral hemorrhage, ischemic stroke, subarachnoid hemorrhage, excluding transient ischemic 
attacks. 
 

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32 
 
COMPREHENSIVE COMPLICATION INDEX 
Slankamenac K, Nederlof N, Pessaux P, et al. The comprehensive complica- tion index: 
a novel and more sensitive endpoint for assessing outcome and reducing sample size 
in randomized controlled trials. Ann Surg. 2014;260:753 – 757.  
Website: https://www.assessurgery.com/ 
 
 
CLASSIFICATION OF POSTOPERATIVE BLEEDING 
Rahbari N, Garden J, Padbury R, Maddern G, Koch M, Hugh T, et al. Post-hepatectomy 
haemorrhage: a definition and grading by the International Study Group of Liver 
Surgery (ISGLS). HPB. 2011; 13(8): 528-35. 
 
 
 
POSTOPERATIVE BILIARY FISTULA CLASSIFICATION 
Brooke M, Figueras J, Ullah S, Rees M, Vauthey JN, Hugh TJ, et al. Prospective 
evaluation of the International Study Group for Liver Surgery definition of bile leak 
after a liver resection and the role of routine operative drainage: an international 
multicentre study. HPB. 2015. 17(1):46-51. 
 

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33 
 
POSTOPERATIVE LIVER FAILURE CLASSIFICATION 
Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch 
M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern 
G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras 
J, Capussotti L, Büchler MW, Weitz J. Posthepatectomy liver failure: a definition and 
grading by the International Study Group of Liver Surgery (ISGLS). Surgery 
2011;149(5):713-24.  
 
 

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34 
ANNEX IV. INTRAOPERATIVE REGISTRATION DOCUMENT. 
 
 
SURGICAL APPROACH 
Open (laparotomy) 
 
Laparoscopy 
 
Robotic 
 
Conversion 
 
TYPE OF LIVER (macrosopic) 
Normal 
 
Steatosis 
 
Fibrosis 
 
Chemotherapy-induced liver injury 
 
Cirrhosis 
 
TYPE OF SURGERY 
Left lateral sectionlectomy (2 and 3) 
 
Bisegmentectomy (5 and 6) 
 
Rigth anterior sectionlectomy (5 and 8) 
 
Right posterior sectionlectomy (6 and 7) 
 
Left hepatectomy  (2, 3 and 4) 
 
Right hepatectomy  (5, 6, 7 y 8) 
 
Central hepatectomy (4, 5 and 8) 
 
Extended right hepatectomy  (4, 5, 6, 7 and 8) 
 
Extended left hepatectomy (2, 3, 4, 5 and 8) 
 
Atypical resection 1 
 
Atypical resection 2 
 
Atypical resection 3 
 
Atypical resection 4a 
 
Atypical resection 4b 
 
Atypical resection 5 
 
Atypical resection 6 
 
Atypical resection 7 
 
Atypical resection 8 
 
Anatomical resection segment 1 
 
Anatomical resection segment 2 
 
Anatomical resection segment 3 
 
Anatomical resection segment 4a 
 
Anatomical resection segment 4b 
 
Anatomical resection segment 5 
 
Anatomical resection segment 6 
 
Anatomical resection segment 7 
 
Anatomical resection segment 8 
 
OTHERS ASSOCIATED PROCEDURES 
Radiofrequency 
 
Microwave 
 
Atypical resectión 
 
Others 
 
OPERATIVE TIME (min) 
 
BLEEDING (ml). 
 
UNITS OF BLOOD TRANSFUSED 
 
TYPE OF BLEEDING  
 
Major intraoperative 
bleeding) 
At the end of the surgical 
intervention 
0: no bleeding (< 1mL/min) 
 
 
1: mild (1-5 mL/min) 
 
 
2: moderate (5-10mL/min) 
 
 
3: severe (10-50mL/min) 
 
 
4: very severe (> 50mL/min) 
 
 
TYPE OF HEMOSTASIS PERFORMED 
Compression 
 
 
Coagulation 
 
 
Suture 
 
 
Application of hemostatic agent 
 
 
Name of hemostatic 
 
 
CLAMPING TIME (min) 
 

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ANNEX V. PATIENT INFORMATION DOCUMENT AND INDIVIDUAL INFORMED 
CONSENT. 
PATIENT INFORMATION DOCUMENT 
 
 
Title: VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER 
SURGERY. PROSPECTIVE AND MULTICENTRIC STUDY. 
 
Promoter:  Aragon Institute for Health Research (IIS Aragon) 
 
Principal researcher: Daniel Aparicio López / Mario Serradilla Martin / José Manuel Ramia 
Ángel. 
 
Tfno: +34 697768059 e-mail: dani_9_93@hotmail.com / dapariciol@salud.aragon.es  
 
Centro: General and Digestive Surgery Department. Miguel Servet University Hospital. 
Zaragoza. Spain 
 
1. Introduction: 
We are writing to you to request your participation in a research project that we are carrying out 
at NAME OF THE COLLABORATING HOSPITAL. Your participation is voluntary, but it is 
important to obtain the knowledge we need. This project has been approved by the Ethics 
Committee, but before making a decision it is necessary that: 
 
- read this entire document 
- understand the information contained in the document 
- ask all the questions you consider necessary 
- make a thoughtful decision 
- sign the informed consent, if you finally want to participate. 
 
If you decide to participate, you will be given a copy of this sheet and the signed consent 
document. Please keep it in case you need it in the future. 
 
2. Why are you being asked to participate? 
Your collaboration is requested because you suffer from a disease that affects the liver and for 
its treatment requires a surgical intervention. This intervention consists of the resection of the 
affected liver tissue. 
 
A total of 259 patients with these characteristics will participate in the study. 
 
3. What is the purpose of this study? 

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36 
With the following study, we intend to register for subsequent analysis the number of liver 
resections performed in 10 centers of moderate-high volume (reference centers) in Spain with 
the intention of determining intraoperative bleeding and validating the VIBe scale in liver surgery. 
Furthermore, we intend to determine the repeatability, reproducibility and usefulness of said 
scale in this type of surgery; and the relationship between the type of bleeding and the 
hemostatic agent used. There is no validated scale in liver surgery on intraoperative bleeding in 
the literature, and with this registry we intend to obtain them. 
 
4. What do I have to do if I decide to participate? 
You do not have to do anything to participate in this registry. You will not be subjected to any 
diagnostic test outside of the usual ones during your diagnostic and therapeutic process. It only 
authorizes us to quantify and record intraoperative bleeding at two moments of the surgical 
intervention (the moment of greatest bleeding and at the end of the surgery). Likewise, your 
medical history will be reviewed to collect the necessary data on the possible complications that 
you may suffer throughout the process. You do not have to go to more visits than usual nor will 
you be asked to carry out any type of survey. 
 
5. What risks or annoyances does it entail? 
Participation in this registry will not suppose any type of risk or additional annoyance for the 
patient. 
 
6. Will I get any benefit from my participation? 
As it is a research study aimed at generating knowledge, it is not likely that you will obtain any 
benefit from your participation, although you will contribute to scientific advancement and social 
benefit. 
 
You will not receive any financial compensation for your participation. 
 
7. How will my personal data be processed? 
Responsible for the treatment: Study coordinator. Daniel Aparicio López 
Purpose: Your personal data will be processed exclusively for the research work referred to in 
this document. 
Legitimation: The treatment of the data of this study is legitimized by your consent to participate. 
 
All the information collected will be treated in accordance with the provisions of current 
legislation on the protection of personal data. Personal data will not be included in the study 
database: neither your name, nor your medical history number nor any information that can 

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37 
identify you. You will be identified by a code that only the research team will be able to associate 
with your name. 
Only the research team will have access to the data in your medical history and no one outside 
the center will be able to consult your history. 
In accordance with the provisions of the data protection legislation (RGPD 2016/679), you can 
exercise the rights of access, modification, opposition and cancellation of data. You can also 
limit the processing of data that are incorrect, request a copy or transfer to a third party 
(portability) the data that you have provided for the study. To exercise your rights, contact the 
principal investigator of the study. You also have the right to contact the Data Protection Agency 
if you are not satisfied. 
If you decide to withdraw your consent to participate in this study, no new data will be added to 
the database, but those that have already been collected will be used. In case you want both 
the data and the samples already collected to be destroyed, you must expressly request it and 
your request will be attended to. 
The coded data can be transmitted to third parties and to other countries but in no case will they 
contain information that can directly identify you, such as name and surname, initials, address, 
social security number, etc. In the event that this assignment occurs, it will be for the same 
purposes of the study described or for use in scientific publications but always maintaining their 
confidentiality in accordance with current legislation. 
The promoter / researcher will adopt the pertinent measures to guarantee the protection of their 
privacy and will not allow their data to be crossed with other databases that could allow their 
identification or that they are used for purposes unrelated to the objectives of this investigation. 
The conclusions of the study will be presented in conferences and scientific publications, but 
they will always be made with grouped data and nothing that can identify it will ever be disclosed. 
 
8. Who finances the study? 
This study is funded by the Investigator Initiated Research (IIR) grant from Baxter S.L. 
 
9. Will I be informed of the results of the study? 
You have the right to know the results of this study, both the general results and those derived 
from your specific data. You also have the right not to know such results if you wish. For this 
reason, in the informed consent document we will ask you which option you prefer. In case you 
want to know the results, the researcher will send you the results. 
 
Can I change my mind? 
Your participation is completely voluntary, you can decide not to participate or withdraw from the 
study at any time without having to give explanations and without this having an impact on your 

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38 
health care (only for projects in the healthcare field). Simply state your intention to the study's 
principal investigator. 
 
What happens if I have any questions during my participation? 
The first page of this document contains the name and contact telephone number of the 
researcher responsible for the study. You can contact him if you have any questions about your 
participation. 
 
 
Thank you very much for your attention, if you finally wish to participate, please sign the attached 
consent document. 
 
INFORMED CONSENT DOCUMENT 
 
Title: VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER 
SURGERY. PROSPECTIVE AND MULTICENTRIC STUDY. 
 
Me, ................................................ .............................. (name and surname of the participant) 
I have read the information sheet that has been provided to me. 
I have been able to ask questions about the study and have received enough information about 
it. 
I have spoken with: .............................................. ............................. (name of researcher) 
I understand that my participation is voluntary. 
I understand that I can withdraw from the study: 
1) whenever you want 
2) without having to explain 
3) without this affecting my medical care 
 
I freely give my consent to participate in this study and I give my consent for the access and use 
of my data as stipulated in the information sheet that has been given to me (and for the genetic 
analysis to be carried out –if applicable-). 
 
I wish to be informed about the results of the study: yes no (check all that apply) 
 
I give my consent for my clinical data to be reviewed by personnel outside the center, for the 
purposes of the study, and I am aware that this consent is revocable. 
 
I have received a signed copy of this Informed Consent. 

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39 
 
Participant signature: 
Date: 
 
I have explained the nature and purpose of the study to the named patient 
Investigator's Signature: 
Date: