Summary Background 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov , NCT03471494 . Findings Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding National Institute for Health Research Global Health Research Unit.
Background: Most published data on pelvic exenteration comes from high-volume quaternary units, with limited data available from outside of this setting. This study reports outcomes of selective pelvic exenteration performed in a low-volume tertiary unit with multidisciplinary support. Methods: A retrospective review of consecutive patients who underwent pelvic exenteration surgery for rectal/anal carcinoma, or gynaecological malignancy at Royal Adelaide Hospital between June 2008 and September 2018. Descriptive statistics and Kaplan-Meier analysis of 5-year disease-free and overall survival for patients treated with curative intent were performed. Results: A total of 54 patients who underwent pelvic exenteration were included. Most patients presented with primary rectal adenocarcinoma, and posterior and total pelvic exenterations were the most common operations performed (>90%). Median total operating time was 323 min, median hospital stay was 15 days, and the readmission rate was 14.8%. The overall complication rate (per patient) was 70.4%, and the re-intervention rate was 20.4%. Thirteen percent of patients required intensive care unit-admission, and there was one postoperative death (1.9%). R0 resection margins were achieved in 81.5% of patients, with R1 and R2 margins in 13.0 and 5.6% of patients, respectively. Estimated 5-year disease-free survival was 38.8%, and 5-year overall survival was 65.7%. Conclusion: Short-and long-term outcomes of selective pelvic exenteration surgery are acceptable in a low-volume specialized tertiary setting with suitable multidisciplinary expertise. If the required expertise is not readily available, then outside referral is recommended.
Introduction Gastrointestinal recovery describes the restoration of normal bowel function in patients with bowel disease. This may be prolonged in two common clinical settings: postoperative ileus and small bowel obstruction. Improving gastrointestinal recovery is a research priority but researchers are limited by variation in outcome reporting across clinical studies. This protocol describes the development of core outcome sets for gastrointestinal recovery in the contexts of postoperative ileus and small bowel obstruction. Method An international Steering Group consisting of patient and clinician representatives has been established. As overlap between clinical contexts is anticipated, both outcome sets will be co‐developed and may be combined to form a common output with disease‐specific domains. The development process will comprise three phases, including definition of outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal‐group stakeholder discussions; online‐facilitated Delphi surveys via international networks; and a consensus meeting to ratify the final output. A nested study will explore if the development of overlapping outcome sets can be rationalized. Dissemination and implementation The final output will be registered with the Core Outcome Measures in Effectiveness Trials initiative. A multi‐faceted, quality improvement campaign for the reporting of gastrointestinal recovery in clinical studies will be launched, targeting international professional and patient groups, charitable organizations and editorial committees. Success will be explored via an updated systematic review of outcomes 5 years after registration of the core outcome set.
Background: In the West, pre-treatment abnormal lateral lymph nodes (LLN+) in patients with a low locally advanced rectal cancer (AJCC Stage III), are treated with neoadjuvant (chemo)radiotherapy (nCRT), without a lateral lymph node dissection (LLND). It has been suggested, however, that LLN+ patients have higher local recurrence (LR) rates than similarly staged patients with abnormal mesorectal lymph nodes only (LLN−), but no comparative data exist. Therefore, we conducted this international multi-center study in the Netherlands and Australia of Stage III rectal cancer patients with either LLN+ or LLN− to compare oncological outcomes from both groups.Materials and Methods: Patients with Stage III low rectal cancer with (LLN+ group) or without (LLN− group) abnormal lateral lymph nodes on pre-treatment MRI were included. Patients underwent nCRT followed by rectal resection surgery with curative intent between 2009 and 2016 with a minimum follow-up of 2-years. No patient had a LLND. Propensity score matching corrected differences in baseline characteristics.Results: Two hundred twenty-three patients could be included: 125 in the LLN+ group and 98 in the LLN− group. Between groups, there were significant differences in cT-stage and in the rate of adjuvant chemotherapy administered. Propensity score matching resulted in 54 patients in each group, with equal baseline characteristics. The 5-year LR rate in the LLN+ group was 11 vs. 2% in the LLN− group (P = 0.06) and disease-free survival (DFS) was 64 vs. 76%, respectively (P = 0.09). Five-year overall survival was similar between groups (73 vs. 80%, respectively; P = 0.90).Conclusions: In Western patients with Stage III low rectal cancer, there is a trend toward worse LR rate and DFS rates in LLN+ patients compared to similarly staged LLN− patients. These results suggest that LLN+ patients may currently not be treated optimally with nCRT alone, and the addition of LLND requires further consideration.
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