Complications significantly postpone postoperative recovery and increase mortality after gastric cancer surgery. However, varied complication rates have been reported in the literature as well as in our annual report of China Gastrointestinal Oncological Surgery League. It appears that there have been some misunderstandings regarding the diagnosis and interventions as well as the etiology of major complications. We should be aware of the fact that reaching worldwide consensus for the diagnostic criteria is a difficult task in most complications, which disabled the possibility of data comparison among different studies in most cases. Disagreements among the Chinese and western surgeons in the complication diagnosis should also be acknowledged when interpreting data from both ends. The western colleagues appreciate more latent manifestations of the complications, which eventually lead to earlier and more aggressive examinations and interventions. We, together with all Chinese centers, need to acknowledge the differences, ensure the integrity of our reported data while proposing respective countermeasures. Although the complication registration may continue to differ among centers, we can register complications with the intervention details so that the reported complications can be classified with the same standard (i.e. Clavien-Dindo scoring system). We should also encourage multi-center collaborations and trials, which facilitate the standardization of complication diagnosis and registration. Recognizing the difficulty and long-course nature of reaching national or even international consensus, we continue aiming at the ultimate goal with our best effort.
China ; Consensus ; Data Collection ; standards ; Diagnostic Techniques and Procedures ; standards ; Digestive System Surgical Procedures ; adverse effects ; Humans ; Postoperative Complications ; classification ; epidemiology ; Registries ; standards ; statistics & numerical data ; Stomach Neoplasms ; surgery

Since the China Gastrointestinal Cancer Surgery Union was established, it has continuously collected the annual reports of 95 gastrointestinal surgery centers nationwide from 2014 to 2017, and collected data on more than 130 000 cases of gastric cancer. This article combines the experience of associated databases at home and abroad to analyze the construction of the China Gastrointestinal Cancer Surgery Union Database, and explore the role of multi-center cooperation and big data analysis in the promotion of gastrointestinal surgery. For a complete database to successfully achieve its ultimate goal, it needs clear goals, continuous funding, a qualified management team, consensus on data content, a high completion rate, and the support and cooperation of an advanced processing system. As a high-quality database with clear construction goals and database project construction based on the goals, while promoting the level of clinical diagnosis and treatment, it is also widely used in risk prediction model development, audit supervision, epidemiological research, health service research, and clinical hypothesis testing, etc. How to build a high-quality database to give a full promotion in clinical diagnosis and treatment is a huge challenge. Although the construction of medical databases in China has just started, we believe that with the further improvement in understanding, management and analysis capabilities for surgical databases, more databases including the China Gastrointestinal Cancer Surgery Union Database will make greater contributions in promoting the development of diagnosis and treatment of gastrointestinal cancer in China and the world.

OBJECTIVETo analyze the change in postoperative complication rate after gastric cancer surgery registered in the Peking University Cancer Hospital in recent 11 years and the learning curve of complication registration, and to investigate how to improve the complication registration and evaluation in gastric cancer surgery.

METHODSPatients who underwent open or laparoscopic gastric cancer surgery between April 14, 2005 and February 15, 2016 in our institution were included in the study, and those without essential clinical and administrative data were excluded. Data were biennially collected, and linear regression was performed to investigate the changes of the following parameters, including overall complication rate, severe complication proportion (proportion of complications with Clavien-Dindo score ≥III(a in the total registered complications), re-operation rate and the major complication rate.

RESULTSA total of 5 666 patients were included in the analysis, with 4 111 males (72.56%) and 1 555 females (27.44%). The average age was (58.87±11.50) years and average BMI was(23.15±3.30) kg/m. There were 305 patients included in the 2005-2006 interval, 810 patients in 2007-2008, 957 patients in 2009-2010, 1 163 patients in 2011-2012, 1 421 patients in 2013-2014, and 1 010 patients in 2015-2016, respectively. The overall re-operation rate was 2.34%(133/5 666), postoperative mortality was 0.41%(23/5 666), registered complication rate was 19.66%(1 114/5 666), severe complication proportion was 32.28%(338/1 047), and the proportion of complication missing the Clavien-Dindo score was 6.01%(67/1 114). The linear regression showed the re-operation rate (r=0.13, P=0.801) and postoperative mortality (r=0.58, P=0.231) remained low (< 4% and < 1% respectively) since 2005, and showed no statistical significance. The registered complication rate showed evident increase from 3.93%(12/305) to 29.13%(414/1 421) between 2005 and 2014 (r=0.92, P=0.010), and slight decrease to 22.77%(230/1 010) in 2015-2016. The severe complication proportion significantly decreased from 6/9 in 2005-2006 to 22.73%(50/220) in 2015-2016 (r=0.90, P=0.014). The proportion of complication missing the Clavien-Dindo score significantly decreased from 25.00%(3/12) in 2005-2006 to 4.35%(10/230) in 2015-2016(r=0.82, P=0.044). The most common complications were infection (9.12%, 517 cases), effusions (6.26%, 355 patients), gastrointestinal motility disorder (4.45%, 252 cases), anastomotic leakage (3.19%, 181 cases) and bleeding (2.31%, 131 cases). The registered rates of these complications all increased since 2005, and the rates of leakage and effusions decreased since 2012 while the others decreased after 2014.

CONCLUSIONSAccording to the data from our institution in the recent 11 years, a learning curve exists in our institution for complication registration in gastric cancer surgery. The administrative data appears to be more reliable than registered complication data in quality and safety evaluation during the learning period. A detailed classification with the Clavien-Dindo score aids to the use of complication data for the quality and safety measurement.

Aged ; Anastomotic Leak ; etiology ; Data Collection ; methods ; statistics & numerical data ; Female ; Gastrectomy ; adverse effects ; mortality ; Humans ; Laparoscopy ; adverse effects ; Male ; Medical Records ; statistics & numerical data ; Middle Aged ; Postoperative Complications ; epidemiology ; Registries ; statistics & numerical data ; Reoperation ; statistics & numerical data ; Retrospective Studies ; Stomach Neoplasms ; complications ; surgery

Objective:To explore the risk factors for postoperative adverse events in older persons with gastrointestinal malignancies and thus provide reference for selection of surgery and evaluation of such patients.Methods:An observational study design was employed, the study cohort comprising patients aged 65 years and over with gastrointestinal malignancies who underwent elective surgery in Peking University Cancer Hospital from 2008 to 2022. In this study, we compared the clinical characteristics (disease type, tumor stage), surgical safety (combined organ resection, operation duration, comorbidities), and treatment outcomes (postoperative complications, unplanned reoperation, and perioperative mortality) of these patients. Multivariate logistic regression analysis was conducted to identify risk factors associated with adverse outcomes.Results:The study cohort comprised 10,135 patients, of whom 74.7% (7,568) were 65–75 years old (excluding 75 years old), 23.6% (2,391) 75–85 years old (excluding 85 years old), and 1.7% (176) ≥85 years old. The type of cancer was colorectal in 63.4% (6,427 patients) and gastric in 36.6% (3,708); 62.0% (6,284/10,135)of the patients had stage II or III disease. The proportion of stage III and stage IV tumors was higher in patients aged over 85 years (47.4% [73/154) and 11.0% [17/154]), respectively, than in those aged 75–85 years (41.6% [854/2 051) and 8.2% [168/2 051]), respectively, and those aged 65–75 years (40.1% [2,576/6,431) and 10.9% [700/6,431]); these differences are statistically significant (χ 2=27.95, P<0.01). Comorbidity was present in 50.6% (5,128/10,135) of the whole study cohort, comprising 58.0% (102/176) of those aged over 85 years, this being significantly higher than the 56.3% (1,346/2,391) in those aged 75–85 years and 48.6% (3,678/7,568) of those aged 65–75 years. The main comorbidities were hypertension (37.3%), diabetes (16.4%), and cardiovascular and cerebrovascular diseases (14.0%). Minimally invasive surgery was performed on 36.9% (3,740/10,135) of the whole study cohort, the 38.4% in 65–75 years old patients being significantly higher than the 32.5% in those aged 75–85 years and the 29.0% in those aged over 85 years; these differences are statistically significant (χ 2=31.97, P<0.01). Preoperative neoadjuvant therapy was administered to 9.1% (924/10,135) of the whole study cohort, the proportion of patients receiving preoperative neoadjuvant therapy being significantly higher in those aged 65–75 years (11.1%) than in those aged 75–85 years (3.4%) and over 85 years (0.6%); these differences are statistically significant (χ 2=148.98, P<0.01). Combined organ resection was performed in 4.9% (496/10,135) of the whole study cohort, the proportion undergoing combined organ resection being significantly lower in those aged over 85 years (2.3%) than in those aged 65–75 years (5.3%) and 75–85 years (3.8%); these differences are statistically significant (χ 2=11.20, P<0.01). The mean operating time was (182.2±76.8) minutes, being significantly higher in those aged 65–75 years (186.6±78.3 minutes) than in those aged 75–85 years (169.4±71.3 minutes) and over 85 years (153.2±53.7 minutes); these differences are statistically significant ( F=46.85, P<0.01). The overall incidence of postoperative complications was 10.9% (802/7,384); the incidence did not differ significantly between the three groups ( P>0.05). The incidence of unplanned reoperation was 1.9% (193/10,135) and of death during hospitalization 0.3% (32/10,135). The perioperative mortality in the three groups was 1.1%, 0.5% and 0.2% in those aged over 85, 75–85, and 65–75 years, respectively. These differences are statistically significant (χ 2=9.71, P<0.01). Among the patients with postoperative complications, 15.0% (120/802) underwent unplanned reoperation, which had a perioperative mortality of 1.0% (8/802), these rates being significantly higher than those for unplanned reoperation (1.1%, 73/6,582) and perioperative mortality (0.4%, 24/6,582) in patients without complications (all P<0.01). The median length of hospital stay was 11 days in patients aged over 85 years; this is significantly longer than the 9 days in those aged 65–75 years and 10 days in those aged 75–85 years (H=37.00, P<0.01). Multivariate logistic regression analysis showed that tumor stage IV (OR=1.56, 95%CI: 1.24–1.96, P<0.01), comorbidities (OR=1.26, 95%CI: 1.08–1.47, P<0.01), open surgery (OR=1.33, 95%CI: 1.13–1.56, P<0.01), and operation time >180 minutes (OR=1.82, 95%CI:1.53–2.15, P<0.01) were risk factors for adverse outcomes. Conclusion:Older patients with gastrointestinal tumors who have comorbidities and stage IV disease and undergo open surgery with a longer operation time are at higher risk of adverse outcomes than patients without these characteristics.

Anastomotic leakage is one of the most serious complications of colorectal surgery. Despite progress in available surgical techniques, the morbidity associated with anastomotic leakage remains high. In this review, we summarize the current clinical status of this complication, the problems it causes, and relevant research achievements. To date, a lack of consensus regarding the diagnosis of anastomotic leakage has resulted in varying rates of diagnosis across countries and regions worldwide. Accurately predicting the occurrence of anastomotic leakage using the established risk factors and preoperative scoring systems remains difficult. Many of the described preventive measures, including defunctioning stoma creation, positive air leak testing, and use of effective tissue adhesives, remain controversial; more evidence-based medical information is urgently needed. Delayed diagnoses of anastomotic leakage also remain common in clinical practice. To prevent catastrophic outcomes, such as reoperations or deaths, early diagnosis is critically important. Parameters local to the area of the anastomosis may facilitate early detection of leakage, but their effectiveness is subject to clinical validation. Lastly, the pathological etiology of anastomotic leakage remains to be determined, and its elucidation may inspire innovative interventions that solve this critical surgical complication.

Objective: To explore the feasibility of assessing complications registration through medical information. Methods: A descriptive case series study was performed to retrospectively collect medical information and complication registration information of gastric cancer patients at Department of Gastrointestinal Cancer Center Ward I, Peking University Cancer Hospital from November 1, 2016 to March 1, 2017 (the first period), and from November 1, 2018 to March 1, 2019 (the second period). Case inclusion criteria: (1) adenocarcinoma confirmed by gastroscopy and biopsy; (2) patients undergoing open surgery or laparoscopic radical gastrectomy; (3) complete postoperative medical information and complication information. Patients who were directly transferred to ICU after surgery and underwent emergency surgery were excluded. Because difference of the complication registration procedure at our department existed before and after 2018, so the above two periods were selected to be used for analysis on enrolled patients. The prescription information during hospitalization, including nursing, medication, laboratory examination, transference, surgical advice, etc. were compared with the current Standard Operating Procedure (SOP, including preoperative routine examinations, inspection, perioperative preventive antibiotic use, postoperative observational tests, inspection, routine nutritional support, prophylactic anticoagulation, and prophylactic inhibition of pancreatic enzymes, etc.) for gastric cancer at our department. Medical order beyond SOP was defined as medical order variation. Postoperative complication was diagnosed using the Clavien-Dindo classification criteria, which was divided into I, II, IIIa, IIIb, IVa, IVb, and V. Medical order variation and complication registration information were compared between the two periods, including consistence between medical order variation and complication registration, missing report, underestimation or overestimation of medical order variation, and registration rate of medical order variation [registration rate = (total number of patients–number of missing report patients)/total number of patients], severe complications (Clavien-Dindo classification ≥ III), medical order variation deviating from SOP and the corresponding inferred grading of complication. The data was organized using Microsoft Office Excel 2010. Results: A total of 177 gastric cancer patients were included in the analysis. The first period group and the second period group comprised 89 and 88 cases, respectively. The registrated complication rate was 23.6% (21/89) and 36.4% (32/88), and the incidence of severe complication was 2.2% (2/89) and 4.5% (4/88) in the first and the second period, respectively. The complication rate inferred from medical order variation was 74.2% (66/89) and 78.4% (69/88), and the incidence of severe complication was 7.9% (7/89) and 4.5% (4/88) in the first and second period, respectively. In the first and second period, the proportions of medical order variation in accordance with registered complication were 36.0% and 45.5% respectively; the proportion of underestimation, overestimation and missing report were 5.6% and 4.5%, 4.5% and 4.5%, 53.9% and 45.5%, respectively; the registration rate of medical order variation was 46.1% and 54.5%; the number of case with grade I complications inferred from medical order variation was 34 (38.2%) and 25 (28.4%), respectively; and the number of grade II was 12 (13.5%) and 15 cases (17.0%), respectively. The reason of the missing report of medical order variation corresponding to grade I complication was mainly the single use of analgesic drugs outside SOP, accounting for 76.5% (26/34) and 64.0% (16/25) in the first and second period respectively, and that corresponding to grade II complication was mainly the use of non-prophylactic antibiotics, accounting for 9/12 cases and 5/15 cases, respectively. Conclusions Medical information can evaluate the morbidity of complication feasibly and effectively. Attention should be paid to routine registration to avoid specific missing report.

Objective:To explore the risk factors for postoperative adverse events in older persons with gastrointestinal malignancies and thus provide reference for selection of surgery and evaluation of such patients.Methods:An observational study design was employed, the study cohort comprising patients aged 65 years and over with gastrointestinal malignancies who underwent elective surgery in Peking University Cancer Hospital from 2008 to 2022. In this study, we compared the clinical characteristics (disease type, tumor stage), surgical safety (combined organ resection, operation duration, comorbidities), and treatment outcomes (postoperative complications, unplanned reoperation, and perioperative mortality) of these patients. Multivariate logistic regression analysis was conducted to identify risk factors associated with adverse outcomes.Results:The study cohort comprised 10,135 patients, of whom 74.7% (7,568) were 65–75 years old (excluding 75 years old), 23.6% (2,391) 75–85 years old (excluding 85 years old), and 1.7% (176) ≥85 years old. The type of cancer was colorectal in 63.4% (6,427 patients) and gastric in 36.6% (3,708); 62.0% (6,284/10,135)of the patients had stage II or III disease. The proportion of stage III and stage IV tumors was higher in patients aged over 85 years (47.4% [73/154) and 11.0% [17/154]), respectively, than in those aged 75–85 years (41.6% [854/2 051) and 8.2% [168/2 051]), respectively, and those aged 65–75 years (40.1% [2,576/6,431) and 10.9% [700/6,431]); these differences are statistically significant (χ 2=27.95, P<0.01). Comorbidity was present in 50.6% (5,128/10,135) of the whole study cohort, comprising 58.0% (102/176) of those aged over 85 years, this being significantly higher than the 56.3% (1,346/2,391) in those aged 75–85 years and 48.6% (3,678/7,568) of those aged 65–75 years. The main comorbidities were hypertension (37.3%), diabetes (16.4%), and cardiovascular and cerebrovascular diseases (14.0%). Minimally invasive surgery was performed on 36.9% (3,740/10,135) of the whole study cohort, the 38.4% in 65–75 years old patients being significantly higher than the 32.5% in those aged 75–85 years and the 29.0% in those aged over 85 years; these differences are statistically significant (χ 2=31.97, P<0.01). Preoperative neoadjuvant therapy was administered to 9.1% (924/10,135) of the whole study cohort, the proportion of patients receiving preoperative neoadjuvant therapy being significantly higher in those aged 65–75 years (11.1%) than in those aged 75–85 years (3.4%) and over 85 years (0.6%); these differences are statistically significant (χ 2=148.98, P<0.01). Combined organ resection was performed in 4.9% (496/10,135) of the whole study cohort, the proportion undergoing combined organ resection being significantly lower in those aged over 85 years (2.3%) than in those aged 65–75 years (5.3%) and 75–85 years (3.8%); these differences are statistically significant (χ 2=11.20, P<0.01). The mean operating time was (182.2±76.8) minutes, being significantly higher in those aged 65–75 years (186.6±78.3 minutes) than in those aged 75–85 years (169.4±71.3 minutes) and over 85 years (153.2±53.7 minutes); these differences are statistically significant ( F=46.85, P<0.01). The overall incidence of postoperative complications was 10.9% (802/7,384); the incidence did not differ significantly between the three groups ( P>0.05). The incidence of unplanned reoperation was 1.9% (193/10,135) and of death during hospitalization 0.3% (32/10,135). The perioperative mortality in the three groups was 1.1%, 0.5% and 0.2% in those aged over 85, 75–85, and 65–75 years, respectively. These differences are statistically significant (χ 2=9.71, P<0.01). Among the patients with postoperative complications, 15.0% (120/802) underwent unplanned reoperation, which had a perioperative mortality of 1.0% (8/802), these rates being significantly higher than those for unplanned reoperation (1.1%, 73/6,582) and perioperative mortality (0.4%, 24/6,582) in patients without complications (all P<0.01). The median length of hospital stay was 11 days in patients aged over 85 years; this is significantly longer than the 9 days in those aged 65–75 years and 10 days in those aged 75–85 years (H=37.00, P<0.01). Multivariate logistic regression analysis showed that tumor stage IV (OR=1.56, 95%CI: 1.24–1.96, P<0.01), comorbidities (OR=1.26, 95%CI: 1.08–1.47, P<0.01), open surgery (OR=1.33, 95%CI: 1.13–1.56, P<0.01), and operation time >180 minutes (OR=1.82, 95%CI:1.53–2.15, P<0.01) were risk factors for adverse outcomes. Conclusion:Older patients with gastrointestinal tumors who have comorbidities and stage IV disease and undergo open surgery with a longer operation time are at higher risk of adverse outcomes than patients without these characteristics.

Postoperative complications of gastrointestinal surgery have become an important indicator for evaluating surgical safety in the process of the domestic and foreign clinical research and practice.The clinical economics evaluation of the complications provides an important reference in the clinical decision-making process,in addition to the mechanism investigation.It reveals that higher cost-effectiveness can be obtained through optimizing complication diagnosis and registration process from a national macroscopic level,while it also uncovers the targets of the yet-to-be improved clinical decision making process in the microscopic analysis.Through clinical economics evaluation,the necessity and feasibility of interventions targeting the complications can be better understood the clinical practice,which would eventually optimize clinical strategies and proper use of the limited health resources.

The postoperative complications in patients with gastric or colorectal cancer has been common but seriously affecting patients' recovery and even their life safety.According to the database of China Gastrointestinal Cancer Surgery Union,abdominal infectious complications are the main causes of secondary surgery and postoperative death,which deserve clinical attention.However,the incidence rate of postoperative abdominal infection varies widely from center to center.Due to the lack of nationwide data,it is unable to determine the incidence of abdominal infectious complications reasonably and formulate the corresponding strategies of evidence-based diagnosis and treatment.Therefore,this multi-center prospective cohort study,i.e.prediction of abdominal complication after gastroenterological surgery (PACAGE),aims to investigate the incidence,classification and outcomes of postoperative abdominal infection in patients with gastric or colorectal cancer,to implement the standardization of the complication registration,and to provide necessary data for improving surgical safety,preventing abdominal infection and decreasing the rate of postoperative complications in the future.

The Prevalence of Abdominal Complications After Gastroenterological Surgery (PACAGE) study was the first to report epidemiological data on postoperative infectious complications of gastrointestinal surgery nationwide in China. Based on the experience of the PACAGE study, this paper mainly discusses the project design management and data quality control of clinical practice-based database on postoperative infectious complications of gastrointestinal surgery. It also emphasises the importance of specific research objectives and resource planning, and highlights the application effect of a simplified case report form combined with software analysis on data quality control. The data mining of the PACAGE database has great potential and broad application prospects to support clinical decision-making and academic research.