Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) - study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study).
ABSTRACT: BACKGROUND:One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning. METHODS:PATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals. A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative. DISCUSSION:PATRONUS will provide essential insights into the patients' assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00013035 (registered on October 26, 2017). Universal Trial Number (UTN): U1111-1202-8863.
Project description:Abdominal adhesions form in response to peritoneal trauma that can occur during surgery. Postoperative adhesions, which develop in approximately 50-85% of patients who have undergone abdominal surgery, often result in severe complications, including intestinal obstruction, female infertility, chronic pain, and contraindication of surgery for future abdominal illnesses such as cancer. Here, we investigated the cell source of collagen production in postoperative adhesions and explored molecular mechanisms of adhesion using microarray. Overall design: Transcriptional profiling of C57BL/6 mouse cecum tissues isolated at 3 different time points during adhesion formation, namely at 3 h, 12 h or 72 h after cauterization and the sham operation, was assessed using microarray analysis
Project description:The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise.Using a 2 x 2 factorial design with continuous effect endpoint (Maximal Oxygen Uptake (VO2peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late postoperative rehabilitation (starting six weeks after surgery); (3) early postoperative rehabilitation alone; (4) today's standard care which is postoperative rehabilitation initiated six weeks after surgery. The preoperative rehabilitation program consists of an individually designed, 30-minute home-based exercise program performed daily. The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling. The primary study endpoint is VO2peak and secondary endpoints include: Six-minute walk distance (6MWD), one-repetition-maximum (1RM), pulmonary function, patient-reported outcomes (PROs) on health-related quality of life (HRQoL), symptoms and side effects of the cancer disease and the treatment of the disease, anxiety, depression, wellbeing, lifestyle, hospitalization time, sick leave, work status, postoperative complications (up to 30 days after surgery) and survival. Endpoints will be assessed at baseline, the day before surgery, pre-intervention, post-intervention, six months after surgery and one year after surgery.The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery.NCT01893580.
Project description:PURPOSE:This randomized controlled, clinical prospective interventional trial was aimed at exploring the effect of patient empowerment on short- and long-term outcomes after major oncologic surgery in elderly cancer patients. METHODS:This trial was performed from February 2011 to January 2014 at two tertiary medical centers in Germany. The study included patients aged 65 years and older undergoing elective surgery for gastro-intestinal, genitourinary, and thoracic cancer. The patients were randomly assigned to the intervention group, i.e. patient empowerment through information booklet and diary keeping, or to the control group, which received standard care. Randomization was done by block randomization in blocks of four in order of enrollment. The primary outcome were 1,postoperative length of hospital stay (LOS) and 2. long-term global health-related quality of life (HRQoL) one year postoperatively. HRQoL was assessed using the EORTC QLQ C30 questionnaire. Secondary outcomes encompassed postoperative stress and complications. Further objectives were the identification of predictors of LOS, and HRQoL at 12 months. RESULTS:Overall 652 patients were included. The mean age was 72 ± 4.9 years, and the majority of patients were male (68.6%, n = 447). The ^median of postoperative length of stay was 9 days (IQR 7-14 day). There were no significant differences between the intervention and the control groups in postoperative LOS (p = 0.99) or global HRQoL after one year (women: p = 0.54, men: p = 0.94). While overall complications and major complications occurred in 74% and 24% of the cases, respectively, frequency and severity of complications did not differ significantly between the groups. Patients in the intervention group reported significantly less postoperative pain (p = 0.03) than the control group. Independent predictors for LOS were identified as severity of surgery, length of anesthesia, major postoperative complications, nutritional state, and pre-operative physical functional capacity measured by the Timed Up and Go-test by multiple robust regressions. CONCLUSION:Patient empowerment through information booklet and diary keeping did not shorten the postoperative LOS in elderly onco-surgical patients, but improved quality of care regarding postoperative pain. Postoperative length of stay is influenced by pre-operative nutritional state, pre-operative functional impairment, severity of surgery, and length of anesthesia. TRIAL REGISTRATION:Clinicaltrials.gov. Identifier NCT01278537.
Project description:INTRODUCTION:Preoperative anemia and old age are independent risk factors for perioperative morbidity and mortality. However, despite the high prevalence of anemia in elderly surgical patients, there is limited understanding of the impact of anemia on postoperative complications and postdischarge quality of life in the elderly. This study aims to investigate how anemia impacts elderly patients undergoing major abdominal surgery in terms of perioperative morbidity, mortality and quality of life for 6 months postoperatively. METHODS AND ANALYSIS:We will conduct a prospective observational study over 12 months of 382 consecutive patients above 65 years old, who are undergoing elective major abdominal surgery in Singapore General Hospital (SGH), a tertiary public hospital. Baseline clinical assessment including full blood count and iron studies will be done within 1 month before surgery. Our primary outcome is presence of morbidity at fifth postoperative day (POD) as defined by the postoperative morbidity survey (POMS). Secondary outcomes will include 30-day trend of POMS complications, morbidity defined by Clavien Dindo Classification system (CDC) and Comprehensive Complication Index (CCI), 6-month mortality, blood transfusion requirements, days alive out of hospital (DaOH), length of index hospital stay, 6-month readmission rates and Health Related Quality of Life (HRQoL). HRQoL will be assessed using EuroQol five-dimensional instrument (EQ-5D) scores at preoperative consult and at 1, 3, and 6 months. ETHICS AND DISSEMINATION:The SingHealth Centralised Institutional Review Board (CIRB Ref: 2017/2640) approved this study and consent will be obtained from all participants. This study is funded by the National Medical Research Council, Singapore (HNIG16Dec003) and the findings will be published in peer-reviewed journals and presented at academic conferences. Deidentified data will be made available from Dryad Repository upon publication of the results.
Project description:BACKGROUND:Health care on equal terms is a cornerstone of the Swedish health care system. Total hip arthroplasty (THA) is considered a success story in Sweden with low frequency of reoperations and restored health-related quality of life (HRQoL). Administratively, health care in Sweden is locally self-governed by 21 counties. In this longitudinal nation-wide observational study we assessed the possible geographical variations in 1-year follow-up patient-reported outcomes (PROs): EQ-5D index, EQ VAS, Pain VAS and Satisfaction VAS. METHODS:Study population consisted of 36,235 Swedish THA patients, operated during 2008 to 2012 due to hip osteoarthritis. Individual data came from Swedish Hip Arthroplasty Register, Statistics Sweden and National Board of Health and Welfare. We used descriptive statistics together with multivariable regression analysis to analyse the data. RESULTS:We observed county level differences in both preoperative and postoperative PROs. The results showed that the differences observed in preoperative PROs could not fully explain the differences observed in postoperative PROs, even after adjustment for patient demographics (age, sex, BMI, Elixhauser comorbidity index, marital status, educational level and disposable income). This indicates that other factors might influence the outcome after THA. CONCLUSION:Likely, structural and process differences such as indication for surgery have an influence on PROs after surgery. Standardization of care at hospital levels may decrease geographical variations in postoperative HRQoL. Remaining differences will then possibly be associated to patient demographics.
Project description:BACKGROUND:Evaluation of variations in pre- and postoperative patient reported outcomes (PRO) and the association between preoperative patient characteristics and health and satisfaction outcomes after total knee arthroplasty (TKA) may support shared decision-making in Germany. Since previous research on TKA health outcomes indicated valuation differences in longitudinal data, experienced-based population weights were used for the first time as an external valuation system to measure discrepancies between patient and average population valuation of HRQoL. METHODS:Baseline data (n =?203) included sociodemographic and clinical characteristics and PROs, measured by the EQ-5D-3?L and WOMAC. Six-month follow-up data (n =?161) included medical changes since hospital discharge, PROs and satisfaction. A multivariate linear regression analysis was performed to evaluate the relationship between preoperative patient characteristics and PRO scores. Patient acceptable symptom state (PASS) was calculated to provide a satisfaction threshold. Patient-reported health-related quality of life (HRQoL) valuations were compared with average experienced-based population values to detect changes in valuation. RESULTS:One hundred thirty-seven subjects met inclusion criteria. All PRO measures improved significantly. Preoperative WOMAC and EQ-5D VAS, housing situation, marital status, age and asthma were found to be predictors of postoperative outcomes. 73% of study participants valued their preoperative HRQoL higher than the general population valuation, indicating response shift. Preoperatively, patient-reported EQ-5D VAS was substantially higher than average experienced-based population values. Postoperatively, this difference declined sharply. Approximately 61% of the patients reported satisfactory postoperative health, being mainly satisfied with results if postoperative WOMAC was ?82.49 (change ?20.25) and postoperative EQ-5D VAS was ?75 (change ?6). CONCLUSION:On average, patients benefited from TKA. Preoperative WOMAC and EQ-5D VAS were predictors of postoperative outcomes after TKA. Particularly patients with high absolute preoperative PRO scores were more likely to remain unsatisfied. Therefore, outcome prediction can contribute to shared-decision making. Using general population valuations as a reference, this study underlined a discrepancy between population and patient valuation of HRQoL before, but not after surgery, thus indicating a potential temporary response shift before surgery.
Project description:BACKGROUND:Insufficient data are available on the prognostic significance of complications after resection of gastric cancer. Therefore, we aimed to assess this gap in our knowledge by studying patients with resectable gastric cancer. METHODS:A multi-institutional retrospective database comprising clinical information of 3575 patients who received resection of gastric cancer from 2010 to 2014 at nine institutions. Grades 2 or greater complications of the Clavien-Dindo classification were judged as clinically relevant postoperative complications, and their associations with postoperative survival were assessed. We assessed the effect of complications on times of initiation and continuation of postoperative adjuvant chemotherapy by S-1. RESULTS:A total of 2954 patients were included in the analysis. Clinically relevant postoperative complications occurred in 664 (23%) patients. Patients' recurrence-free survival rate incrementally decreased as the grade of complications became greater. Patients with abdominal complications (eg, leakage of pancreatic fluids, intra-abdominal abscess, and anastomotic leakage) and those with nonabdominal complications (eg, pneumonia) experienced worse recurrence-free survival compared to those without complications. Patients who had complications were generally at greater risk of disease recurrence, except for those who underwent laparoscopic surgery and those with pathological stage I. Delayed initiation and shorter continuation of adjuvant S-1 chemotherapy was experienced by patients with postoperative complications. CONCLUSIONS:Postoperative complications adversely affected the prognosis in patients with resectable gastric cancer.
Project description:BACKGROUND:There are increasing studies showing that the use of a lung-protective ventilation strategy has a lung protection effect in patients undergoing abdominal surgery; however, the appropriate positive end-expiratory pressure (PEEP) has not yet defined. Adopting a suitable PEEP may prevent postoperative pulmonary complications. Robot-assisted laparoscopic surgery is the newest and most minimally invasive treatment for bladder cancer or prostate cancer. It is also necessary to consider the effects of Trendelenburg position with pneumoperitoneum on airway pressure and pulmonary function. The role of PEEP during the intraoperative period in preventing postoperative pulmonary complications for robot-assisted laparoscopic surgery is not clearly defined. METHODS/DESIGN:A total of 208 patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer will be enrolled and then randomly assigned to a standard PEEP (6-8 cm H2O) group and a low PEEP (≤2 cm H2O) group. Both groups will receive an inspired oxygen fraction of 0.50 and a tidal volume of 8 mL/kg ideal body weight. Standard perioperative fluid management standardization and analgesic treatments will be applied in both groups. The primary endpoint is postoperative pulmonary complications within 7 days after surgery. Secondary endpoints are the modified clinical pulmonary infection score, postoperative extrapulmonary complications, postoperative surgical complications, intensive care unit length of stay, hospital length of stay, and 30-day mortality. DISCUSSION:This trial aimed to assess the effects of low tidal volumes combined with intraoperative PEEP ventilation strategy on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer. TRIAL REGISTRATION:ID: ChiCTR1800019867 . Registered on December 2, 2018.
Project description:To test postoperative serum albumin drop (?Alb) as a marker of surgical stress response and early predictor of clinical outcomes.Prospective cohort study (NCT02356484). Albumin was prospectively measured in 138 patients undergoing major abdominal surgery. Blood samples were collected before surgery and on postoperative days 0, 1 2 and 3. ?Alb was compared to the modified estimation of physiologic ability and surgical stress (mE-PASS) score and correlated to the performances of C reactive protein (CRP), procalcitonin (PCT) and lactate (LCT). Postoperative outcomes were postoperative complications according to Clavien classification and Comprehensive Complication Index (CCI), and length of hospital stay (LoS).Department of abdominal surgery in a European tertiary centre.Adult patients undergoing elective major abdominal surgery, with anticipated duration ?2?hours. Patients on immunosuppressive or antibiotic treatments before surgery were excluded.The level of serum albumin rapidly dropped after surgery. ?Alb correlated to the mE-PASS score (r=0.275, p=0.01) and to CRP increase (r=0.536, p<0.001). ?Alb also correlated to overall complications (r=0.485, p<0.001), CCI (r=0.383, p<0.001) and LoS (r=0.468, p<0.001). A ?Alb ?10?g/L yielded a sensitivity of 77.1% and a specificity of 67.2% (AUC: 78.3%) to predict complications. Patients with ?Alb ?10?g/L on POD 1 showed a threefold increased risk of overall postoperative complications.Early postoperative decrease of serum albumin correlated with the extent of surgery, its metabolic response and with adverse outcomes such as complications and length of stay. A decreased concentration of serum albumin ?10?g/L on POD 1 was associated with a threefold increased risk of overall postoperative complications and may thus be used to identify patients at risk.
Project description:To identify factors associated with mortality in older adults 30, 180, and 365 days after emergency major abdominal surgery.A retrospective study linked to Medicare claims from 2000 to 2010.Health and Retirement Study (HRS).Medicare beneficiaries aged 65.5 enrolled in the HRS from 2000 to 2010 with at least one urgent or emergency major abdominal surgery and a core interview from the HRS within 3 years before surgery.Survival analysis was used to describe all-cause mortality 30, 180, and 365 days after surgery. Complementary log-log regression was used to identify participant characteristics and postoperative events associated with poorer survival.Four hundred individuals had one of the urgent or emergency surgeries of interest, 24% of whom were aged 85 and older, 50% had coronary artery disease, 48% had cancer, 33% had congestive heart failure, and 37% experienced a postoperative complication. Postoperative mortality was 20% at 30 days, 31% at 180 days, and 34% at 365 days. Of those aged 85 and older, 50% were dead 1 year after surgery. After multivariate adjustment including postoperative complications, dementia (hazard ratio (HR) = 2.02, 95% confidence interval (CI) = 1.24-3.31), hospitalization within 6 months before surgery (HR = 1.63, 95% CI = 1.12-2.28), and complications (HR = 3.45, 95% CI = 2.32-5.13) were independently associated with worse 1-year survival.Overall mortality is high in many older adults up to 1 year after undergoing emergency major abdominal surgery. The occurrence of a complication is the clinical factor most strongly associated with worse survival.