Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer: A multicenter randomized clinical trial protocol (FRAGINOC).

INTRODUCTION: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). MATERIALS AND METHODS: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. DISCUSSION: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.

Acute kidney injury following major emergency abdominal surgery - a retrospective cohort study based on medical records data.

BACKGROUND: Acute Kidney Injury (AKI) is a frequent and serious postoperative complication in trauma or critically ill patients in the intensive care unit. We aimed to estimate the risk of AKI following major emergency abdominal surgery and the association between AKI and 90-day postoperative mortality. METHODS: In this retrospective cohort study, we included patients undergoing major emergency abdominal surgery at the Department of Surgery, Zealand University Hospital, Denmark, from 2010 to 2016. The primary outcome was the occurrence of AKI within postoperative day seven (POD7). AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO)-criteria. The risk of AKI was analysed with a multivariable logistic regression. The association between AKI and 90-day mortality was analysed with a multivariable survival analysis. RESULTS: In the cohort, 122 out of 703 (17.4%) surgical patients had AKI within POD7. Of these, 82 (67.2%) had AKI stage 1, 26 (21.3%) had AKI stage 2, and 14 (11.5%) had AKI stage 3. Fifty-eight percent of the patients who developed postoperative AKI did so within the first 24 h of surgery. Ninety-day mortality was significantly higher in patients with AKI compared with patients without AKI (41/122 (33.6%) versus 40/581 (6.9%), adjusted hazard ratio 4.45 (95% confidence interval 2.69-7.39, P < 0.0001)), and rose with increasing KDIGO stage. Pre-existing hypertension and intraoperative peritoneal contamination were independently associated with the risk of AKI. CONCLUSIONS: The risk of AKI is high after major emergency abdominal surgery and is independently associated with the risk of death within 90 days of surgery.

Quality of recovery after major emergency abdominal surgery: a prospective observational cohort study.

BACKGROUND: Major emergency abdominal surgery results in high morbidity and mortality. We aimed to describe patient-reported quality of recovery after major emergency abdominal surgery. METHODS: A prospective observational cohort study of patients undergoing major emergency abdominal surgery at a University Hospital was conducted in the period between November 2016 and February 2017. Patients were interviewed using the 15-item questionnaire Quality of Recovery (QoR-15) six times over the first 30 postoperative days. Patients' maximum score of QoR-15 ranging from 0-150 were divided into four groups depending on recovery status going from poor (score of 0-89), moderate (score of 90-121), good (score of 122-135) to excellent (score of 136-150) recovery. RESULTS: A total of 37 patients were included in the trial. At postoperative day (POD) 1 the recovery status of the patients was mainly poor to moderate (poor N.=8 [22%], moderate N.=23 [62%], good N.=4 [11%] and excellent N.=2 [5%]). Sixteen (55%) of the patients reported a poor or moderate recovery within the first 7 days after surgery, which advanced to good or excellent recovery (N.=19 [68%]) from POD 14. The patients were not fully recovered at POD 30 (N.=18 [62%] had an excellent recovery). CONCLUSIONS: Recovery measured by QoR-15 is substantially affected after major emergency abdominal surgery even after 14- and 30 days postoperatively. The patients were poor or only moderately recovered within the first seven postoperative days and only 62% of the patients were fully recovered at postoperative day 30.