Langenbecks Arch Surg DOI 10.1007/s00423-014-1176-8
ORIGINAL ARTICLE
International quality assurance project in colorectal cancer—unifying diagnostic and histopathological evaluation O. Jannasch & A. Udelnow & G. Romano & A. Dziki & D. Pavalkis & H. Lippert & P. Mroczkowski
Received: 30 September 2013 / Accepted: 17 February 2014 # Springer-Verlag Berlin Heidelberg 2014
G. Romano Department of Surgical Oncology, Istituto Nazionale Per Lo Studio E La Cura Dei Tumori “Fondazione Giovanni Pascale”, IRCCS, Naples, Italy
Results A total of 12,691 patients (6,756 with colon cancer, 5,935 with rectal cancer) were included in the analysis. Preoperative diagnostics differed significantly between countries. For pT and pN stages, several quality differences could be demonstrated, including missing stages (colon cancer: pT 5.7–12.5 %, pN 2.5–11.0 %; rectal cancer: pT 1.1–5.6 %, pN 1.1–15.5 %). The most relevant differences for short-term outcomes in colon cancer were found in general complications (4.2–22.8 %) and tumour-free status at discharge (74.5–91.7 %). In-hospital deaths ranged between 2.5 and 4.3 % and did not show significant differences. For rectal cancer, the country with the highest percentage of tumours localised less than 4 cm from the anal verge (16.0 %) showed the lowest frequency of amputation (8.5 %). Outcome differences were found for general complications (3.2–18.8 %), anastomotic leakage (0–4.3 %) and tumour-free status at discharge (72.9–87.6 %). In-hospital deaths ranged between 1.1 and 3.2 %. Conclusion This study demonstrates the feasibility of an international quality assurance project in colorectal cancer. This concept ensures data analysis based on a comparable data input. Differences in preoperative diagnostics, completeness of histopathological evaluation and short-term outcomes for Germany, Poland and Italy might result from disparities in socioeconomic factors and implementation of existing guidelines. Further activities are necessary to warrant the use of common standards in outcome control.
A. Dziki Department of General and Colorectal Surgery, Medical University of Lodz, Lodz, Poland
Keywords Quality assurance . Colon cancer . Rectal cancer . EURECCA . International study
D. Pavalkis Department of Surgery, University of Medicine Kaunas, Kaunas, Lithuania
Introduction
H. Lippert : P. Mroczkowski (*) AN-Institute of Quality Assurance in Operative Medicine, Otto-von-Guericke University of Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany e-mail: [email protected]
Colorectal cancer is the second most common cause of tumour-related death in Europe [1]. Treatment displays huge international differences in outcome [2]. Therefore, quality assurance is an important issue. Currently, 11 European
Abstract Purpose Several European countries are undertaking quality control projects in colorectal cancer. These efforts have led to improvements in survival, but a comparison between different projects reveals questionable results. The aim of this study is the presentation of results from hospitals in three different European countries participating in the International Quality Assurance in Colorectal Cancer (IQACC) project. Methods For this publication, patients with cancer of the colon or rectum treated in 2009 and 2010 and recorded in the IQACC (Germany, Poland and Italy) were analysed. The comparison included number of patients, age, preoperative diagnostics (CT of the abdomen and thorax, MRI, colonoscopy, ultrasound, tumour markers), surgical approach, metastasis, height of rectal cancer and histopathological examination of a specimen (T stage, N stage and MERCURY classification for rectum resection). For short-term outcomes, general complications, wound dehiscence, tumour-free status at discharge, anastomotic leakage and in-hospital mortality were analysed. O. Jannasch : A. Udelnow : H. Lippert : P. Mroczkowski Department of General, Abdominal and Vascular Surgery, Otto-von-Guericke University of Magdeburg, Magdeburg, Germany
Langenbecks Arch Surg
countries are undertaking quality control projects in colorectal cancer. These include Denmark, Sweden, Norway, the UK, Germany, Spain, Belgium, Poland, the Netherlands, Lithuania and Italy [3, 4]. These efforts have led to improvements in survival [5]. The European Registration of Cancer Care (EURECCA) framework has been initiated to improve cooperation between national projects. The aim is to develop a European colorectal audit structure to analyse diagnostic and treatment improvements and assure realisation in daily health care. In a recently published paper [6], we have demonstrated different diagnostic and therapeutic standards in different countries. This makes the feasibility of an international comparison between different projects questionable. However, is a common international project, using unified descriptions and questionnaires, feasible? In this paper, for the first time, we present the results from three different European countries participating in an international quality assurance in colorectal cancer project.
Patients and methods Study design and data assessment The analysis concerned patients with cancer of the colon or rectum treated from 1 January 2009 to 31 December 2010 and recorded in the prospective observational International Quality Assurance in Colorectal Cancer (Germany, Poland and Italy) project managed by the Otto-von-Guericke University of Magdeburg, Germany [7]. The project was voluntary and based on the anonymity of both patients and hospitals. Data were provided by surgical departments for every patient treated for colorectal cancer and sampled in an online questionnaire. All of the information was based on data from the participating hospitals and reflected the documentation from the attending surgeon and pathologist evaluating the specimen. For colon cancer patients, preoperative diagnostics included CT of the abdomen and chest, total colonoscopy, abdominal ultrasound and tumour markers. The rate of metastatic disease and use of a laparoscopic approach were recorded. The short-term outcome was described by the frequency of relaparotomy, wound dehiscence, anastomotic leakage and inhospital mortality. R0 status was defined as histologically complete resection without any residual tumour. A general postoperative complication was considered to comprise one or more of the following: urinary tract infection, pulmonary complications, cardiac complications, thrombosis, renal complications, neurological/psychiatric complications, fever (>38 °C, duration >2 days) and multiple organ failure. For rectal cancer patients, preoperative diagnostics included CT of the abdomen and MRI of the pelvis. The rate of metastatic disease and use of a laparoscopic approach were recorded. Tumour localisation was defined as the distance between the anal verge and the lower margin of the tumour
measured in rigid rectoscopy. The amputation rate included standard or extralevator abdominoperineal resection. The quality of total mesorectal excision (TME) was assessed according to the MERCURY classification [8]. Short-term outcome was defined by general complications, wound dehiscence, tumour-free status at discharge, anastomotic leakage and in-hospital mortality. As the authors wanted to describe differences between practices in the participating countries without “blaming and shaming”, the following analyses (with the exception of patient numbers and age) compared groups labelled not with the names of the three countries but with the letters A, B and C. Statistical analyses and software The statistical calculations were performed using the R software [9]. Comparisons of groups were undertaken with scalar variables using the t test in the case of normal distribution and the Mann-Whitney U (MWU) test otherwise. Categorical variables were tested using the chi-square test and nominal variables using Fisher’s exact test. Statistical significance was defined as a two-tailed p value of ≤0.05. Ethics The study was conducted according to the Declaration of Helsinki and in adherence with good clinical practice guidelines. Participation in the study was voluntary, the data collection was confidential and the data analysis anonymous. The study design did not include any influence on methods or course of treatment. Therefore, as confirmed by the Ethics Committee of the University of Magdeburg, ethical approval was not required. All patients gave their written informed consent for data collection and evaluation.
Results The study covered the period 1 January 2009 to 31 December 2010 and included a total of 12,691 patients. The sample comprised 6,756 patients treated for colon cancer and 5,935 treated for rectal cancer. The majority of the patients were in Germany (colon 90.7 %, rectum 87.5 %). The median age ranged between 67 and 72 years for patients with colon cancer and 68 and 69 years for patients with rectal cancer (Table 1). Colon cancer Preoperative diagnostic procedures differed considerably between the groups. CT of the abdomen was done for 37.8 % of patients in group B, 90.7 % in group C and 92.5 % in group A.
Langenbecks Arch Surg Table 1 Number and median age of patients
Colon Rectum Median age (years): colon Median age (years): rectum
Table 3 Colon cancer—histopathological evaluation
Germany
Poland
Italy
n
n
n
%
%
Total n %
6,129 90.7 507 7.5 120 1.8 6,756 5,193 87.5 648 10.9 94 1.6 5,935 72 68 67 69 68 68
Differences between groups A and B and B and C were significant (p
ORIGINAL ARTICLE
International quality assurance project in colorectal cancer—unifying diagnostic and histopathological evaluation O. Jannasch & A. Udelnow & G. Romano & A. Dziki & D. Pavalkis & H. Lippert & P. Mroczkowski
Received: 30 September 2013 / Accepted: 17 February 2014 # Springer-Verlag Berlin Heidelberg 2014
G. Romano Department of Surgical Oncology, Istituto Nazionale Per Lo Studio E La Cura Dei Tumori “Fondazione Giovanni Pascale”, IRCCS, Naples, Italy
Results A total of 12,691 patients (6,756 with colon cancer, 5,935 with rectal cancer) were included in the analysis. Preoperative diagnostics differed significantly between countries. For pT and pN stages, several quality differences could be demonstrated, including missing stages (colon cancer: pT 5.7–12.5 %, pN 2.5–11.0 %; rectal cancer: pT 1.1–5.6 %, pN 1.1–15.5 %). The most relevant differences for short-term outcomes in colon cancer were found in general complications (4.2–22.8 %) and tumour-free status at discharge (74.5–91.7 %). In-hospital deaths ranged between 2.5 and 4.3 % and did not show significant differences. For rectal cancer, the country with the highest percentage of tumours localised less than 4 cm from the anal verge (16.0 %) showed the lowest frequency of amputation (8.5 %). Outcome differences were found for general complications (3.2–18.8 %), anastomotic leakage (0–4.3 %) and tumour-free status at discharge (72.9–87.6 %). In-hospital deaths ranged between 1.1 and 3.2 %. Conclusion This study demonstrates the feasibility of an international quality assurance project in colorectal cancer. This concept ensures data analysis based on a comparable data input. Differences in preoperative diagnostics, completeness of histopathological evaluation and short-term outcomes for Germany, Poland and Italy might result from disparities in socioeconomic factors and implementation of existing guidelines. Further activities are necessary to warrant the use of common standards in outcome control.
A. Dziki Department of General and Colorectal Surgery, Medical University of Lodz, Lodz, Poland
Keywords Quality assurance . Colon cancer . Rectal cancer . EURECCA . International study
D. Pavalkis Department of Surgery, University of Medicine Kaunas, Kaunas, Lithuania
Introduction
H. Lippert : P. Mroczkowski (*) AN-Institute of Quality Assurance in Operative Medicine, Otto-von-Guericke University of Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany e-mail: [email protected]
Colorectal cancer is the second most common cause of tumour-related death in Europe [1]. Treatment displays huge international differences in outcome [2]. Therefore, quality assurance is an important issue. Currently, 11 European
Abstract Purpose Several European countries are undertaking quality control projects in colorectal cancer. These efforts have led to improvements in survival, but a comparison between different projects reveals questionable results. The aim of this study is the presentation of results from hospitals in three different European countries participating in the International Quality Assurance in Colorectal Cancer (IQACC) project. Methods For this publication, patients with cancer of the colon or rectum treated in 2009 and 2010 and recorded in the IQACC (Germany, Poland and Italy) were analysed. The comparison included number of patients, age, preoperative diagnostics (CT of the abdomen and thorax, MRI, colonoscopy, ultrasound, tumour markers), surgical approach, metastasis, height of rectal cancer and histopathological examination of a specimen (T stage, N stage and MERCURY classification for rectum resection). For short-term outcomes, general complications, wound dehiscence, tumour-free status at discharge, anastomotic leakage and in-hospital mortality were analysed. O. Jannasch : A. Udelnow : H. Lippert : P. Mroczkowski Department of General, Abdominal and Vascular Surgery, Otto-von-Guericke University of Magdeburg, Magdeburg, Germany
Langenbecks Arch Surg
countries are undertaking quality control projects in colorectal cancer. These include Denmark, Sweden, Norway, the UK, Germany, Spain, Belgium, Poland, the Netherlands, Lithuania and Italy [3, 4]. These efforts have led to improvements in survival [5]. The European Registration of Cancer Care (EURECCA) framework has been initiated to improve cooperation between national projects. The aim is to develop a European colorectal audit structure to analyse diagnostic and treatment improvements and assure realisation in daily health care. In a recently published paper [6], we have demonstrated different diagnostic and therapeutic standards in different countries. This makes the feasibility of an international comparison between different projects questionable. However, is a common international project, using unified descriptions and questionnaires, feasible? In this paper, for the first time, we present the results from three different European countries participating in an international quality assurance in colorectal cancer project.
Patients and methods Study design and data assessment The analysis concerned patients with cancer of the colon or rectum treated from 1 January 2009 to 31 December 2010 and recorded in the prospective observational International Quality Assurance in Colorectal Cancer (Germany, Poland and Italy) project managed by the Otto-von-Guericke University of Magdeburg, Germany [7]. The project was voluntary and based on the anonymity of both patients and hospitals. Data were provided by surgical departments for every patient treated for colorectal cancer and sampled in an online questionnaire. All of the information was based on data from the participating hospitals and reflected the documentation from the attending surgeon and pathologist evaluating the specimen. For colon cancer patients, preoperative diagnostics included CT of the abdomen and chest, total colonoscopy, abdominal ultrasound and tumour markers. The rate of metastatic disease and use of a laparoscopic approach were recorded. The short-term outcome was described by the frequency of relaparotomy, wound dehiscence, anastomotic leakage and inhospital mortality. R0 status was defined as histologically complete resection without any residual tumour. A general postoperative complication was considered to comprise one or more of the following: urinary tract infection, pulmonary complications, cardiac complications, thrombosis, renal complications, neurological/psychiatric complications, fever (>38 °C, duration >2 days) and multiple organ failure. For rectal cancer patients, preoperative diagnostics included CT of the abdomen and MRI of the pelvis. The rate of metastatic disease and use of a laparoscopic approach were recorded. Tumour localisation was defined as the distance between the anal verge and the lower margin of the tumour
measured in rigid rectoscopy. The amputation rate included standard or extralevator abdominoperineal resection. The quality of total mesorectal excision (TME) was assessed according to the MERCURY classification [8]. Short-term outcome was defined by general complications, wound dehiscence, tumour-free status at discharge, anastomotic leakage and in-hospital mortality. As the authors wanted to describe differences between practices in the participating countries without “blaming and shaming”, the following analyses (with the exception of patient numbers and age) compared groups labelled not with the names of the three countries but with the letters A, B and C. Statistical analyses and software The statistical calculations were performed using the R software [9]. Comparisons of groups were undertaken with scalar variables using the t test in the case of normal distribution and the Mann-Whitney U (MWU) test otherwise. Categorical variables were tested using the chi-square test and nominal variables using Fisher’s exact test. Statistical significance was defined as a two-tailed p value of ≤0.05. Ethics The study was conducted according to the Declaration of Helsinki and in adherence with good clinical practice guidelines. Participation in the study was voluntary, the data collection was confidential and the data analysis anonymous. The study design did not include any influence on methods or course of treatment. Therefore, as confirmed by the Ethics Committee of the University of Magdeburg, ethical approval was not required. All patients gave their written informed consent for data collection and evaluation.
Results The study covered the period 1 January 2009 to 31 December 2010 and included a total of 12,691 patients. The sample comprised 6,756 patients treated for colon cancer and 5,935 treated for rectal cancer. The majority of the patients were in Germany (colon 90.7 %, rectum 87.5 %). The median age ranged between 67 and 72 years for patients with colon cancer and 68 and 69 years for patients with rectal cancer (Table 1). Colon cancer Preoperative diagnostic procedures differed considerably between the groups. CT of the abdomen was done for 37.8 % of patients in group B, 90.7 % in group C and 92.5 % in group A.
Langenbecks Arch Surg Table 1 Number and median age of patients
Colon Rectum Median age (years): colon Median age (years): rectum
Table 3 Colon cancer—histopathological evaluation
Germany
Poland
Italy
n
n
n
%
%
Total n %
6,129 90.7 507 7.5 120 1.8 6,756 5,193 87.5 648 10.9 94 1.6 5,935 72 68 67 69 68 68
Differences between groups A and B and B and C were significant (p
