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The Impact of Liver Disease and Serum Albumin Jonathan Montomoli

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The Impact of Liver Disease and Serum Albumin Jonathan Montomoli Short-term prognosis after colorectal surgery: The impact of liver disease and serum albumin PhD dissertation Jonathan Montomoli Health Aarhus University Department of Clinical Epidemiology, Aarhus University Hospital Supervisors and collaborator Henrik Toft Sørensen, MD, PhD, DMSc, professor (main supervisor) Department of Clinical Epidemiology, Aarhus University Hospital, Denmark Tove Nilsson, MD, DMSc, external clinical associate professor (supervisor) Department of Clinical Epidemiology, Aarhus University Hospital, Denmark Rune Erichsen, MD, PhD, external researcher (collaborator) Department of Clinical Epidemiology, Aarhus University Hospital, Denmark Assessment committee Henrik Højgaard Rasmussen, MD, PhD, professor Department of Gastroenterology and Hepatology, Aalborg University Hospital, Denmark Lars Lund, MD, DMSc, professor Department of Urology, Odense University Hospital, Denmark Niels Kristian Aagard, MD, PhD (chairman) Department of Medicine V, Aarhus University Hospital, Denmark ii Preface I clearly remember my first time in Denmark. I arrived March 5th 2008 and spent three months working on my bachelor thesis. It was my first experience with research and, definitely, ignited my interest in hepatology. Many events occurred since then but with no doubt, nothing would have happened if professor Bianchi had not been persuaded by my repeated plea to go abroad, and professor Vilstrup had not graciously accepted to host an Italian student at the Department V for a research project. The enthusiasm at the end of the three months was the reason for my return to Denmark in January 2010, looking for a research position. That was when I first met professor Henrik Toft Sørensen. I left our first meeting feeling that he might be the mentor I was looking for and I was right! His endless knowledge, meticulous attention to detail, and his ability to keep sight of the overall project, continuously stimulated me to improve my work and explain my research decisions. I am most grateful to him for that. Special gratitude is owed to Rune for providing invaluable advice, criticism, and, most of all, for his friendship. Writing this thesis would have been impossible without considerable assistance from the highly skilled statisticians at KEA that helped me to choose appropriate statistical methods. A special thanks to Anil because his Indian peace and happiness taught me how to enjoy every day and survive the hard time of writing my thesis. My gratitude to Claus and Henrik N. for helping me “kick-start” each day with our daily espresso on arrival at KEA. I would also like to thank the always available administrative staff at KEA, the PhD Association for all the productive meetings aimed to improve PhD education, Aarhus University for financial support, and the Mount Tabor community for the valuable time spent together. Furthermore, a special gratitude to all the patients that contributed with their information to the project. Finally, I would like to thank my parents and sister for their unconditional support and my wonderful wife Marica for her constant presence at my side and unfailing fight for our dreams. In conclusion, this dissertation was possible thanks to many people. I have therefore decided to use the term “we” in the thesis to highlight that I have not been alone in this endeavor. iii iv The dissertation is based on the following three papers: I. Montomoli J, Erichsen R, Christiansen CF, Ulrichsen SP, Pedersen L, Nilsson T, Sørensen HT. Liver disease and 30-day mortality after colorectal cancer surgery: a Danish population-based cohort study. BMC Gastroenterol. 2013;13:66 II. Montomoli J, Erichsen R, Strate LL, Pedersen L, Nilsson T, Sørensen HT. Coexisting liver disease is associated with increased mortality after diverticular disease surgery. Submitted. III. Montomoli J, Erichsen R, Antonsen S, Nilsson T, Sørensen HT. Impact of preoperative serum albumin on 30-day mortality, reoperation, and acute kidney injury following surgery for colorectal cancer: a population-based cohort study. In manuscript. v List of abbreviations AKI Acute kidney injury BCG Bromocresol green CCI Charlson Comorbidity Index CI Confidence interval CPR number Civil Personal Registration number CRC Colorectal cancer CRP C-reactive protein CRS Civil Registration System CTP classification Child-Turcotte-Pugh classification DD Diverticular disease DCR Danish Cancer Registry DNRP Danish National Registry of Patients GI Gastrointestinal ICD International Classification of Diseases HSA Human serum albumin HR Hazard ratio INR International normalized ratio KDIGO Kidney Disease: Improving Global Outcomes LABKA Laboratory information system database MELD Model for end-stage liver disease NOMESCO Nordic Medico Statistical Committee OR Odds ratio PPV Positive predictive value TNM system Tumor Node Metastasis system vi Table of contents 1. Introduction ........................................................................................................................................ 1 2. Background ......................................................................................................................................... 5 2.1 Prognosis ....................................................................................................................................... 5 2.1.1 Studying prognosis and causality in surgical patients ........................................................... 5 2.1.2 Measuring the impact of prognostic factors in surgical patients .......................................... 7 2.2 Colorectal surgery ......................................................................................................................... 8 2.2.1 Prognosis following colorectal cancer surgery .................................................................... 10 2.2.2 Prognosis following diverticular disease surgery ................................................................ 11 2.3 Surgical prognosis in patients with liver disease (study I and study II) ....................................... 13 2.3.1 Existing literature on liver disease and colorectal surgery .................................................. 14 2.3.2 Limitations of the existing literature ................................................................................... 20 2.4 Human serum albumin and its association with prognosis ........................................................ 21 2.5 Preoperative human serum albumin and surgical prognosis (study III) ..................................... 23 2.5.1 Existing literature on albumin and colorectal cancer surgery ............................................. 24 2.5.2 Limitations of the existing literature ................................................................................... 30 3. Aims of the dissertation ................................................................................................................... 31 4. Methods ........................................................................................................................................... 33 4.1 Setting ......................................................................................................................................... 33 4.2 Data sources ................................................................................................................................ 33 4.2.1 The Civil Registration System (studies l-lll) .......................................................................... 33 4.2.2 The Danish National Registry of Patients (studies I-III) ....................................................... 33 4.2.3 The Danish Cancer Registry (study l and study III) .............................................................. 34 4.2.4 The laboratory information system database (study III) ..................................................... 34 4.3 Study design ................................................................................................................................ 36 4.4 Study populations ....................................................................................................................... 36 4.5 Main prognostic factors .............................................................................................................. 37 4.6 Outcomes .................................................................................................................................... 38 4.6.1 Mortality .............................................................................................................................. 38 4.6.2 Reoperation ......................................................................................................................... 38 4.6.3 Acute Kidney Injury ............................................................................................................. 38 vii 4.7 Potential confounding factors ..................................................................................................... 38 4.8 Statistical analysis........................................................................................................................ 39 4.8.1 Characteristics of patients undergoing colorectal surgery.................................................. 40 4.8.2 Cumulative incidence proportions (absolute risks) ............................................................. 40 4.8.3 Cox proportional hazard regression analyses (relative risks) .............................................. 40 4.8.4 Stratified
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