Meta-analysis of randomized clinical trials comparing robotic versus laparoscopic surgery for mid-low rectal cancers.

INTRODUCTION: Robotic surgery (RS) is experiencing major development, particularly in the context of rectal cancer. The aim of this meta-analysis was to summarize data from the literature, focusing specifically on the safety and effectiveness of robotic surgery in mid-low rectal cancers, based on the hypothesis that that robotic surgery can find its most rational indication in this anatomical location. METHOD: The meta-analysis was conducted according to the PRISMA 2000 recommendations, including all randomized trials that compared robotic surgery versus laparoscopic surgery (LS) that were found in the Medline-PICO, Cochrane Database, Scopus and Google databases. Data were extracted independently by two reviewers. The risk of bias was analyzed according to the Cochrane Handbook method and the certainty of the evidence according to the GRADE method. The analysis was carried out with R software Version 4.2-3 using the Package for Meta-Analysis "meta" version 6.5-0. RESULTS: Eight randomized trials were included (with a total of 2342 patients), including four that focused specifically on mid-low rectal cancer (n=1,734 patients). No statistically significant difference was found for overall morbidity, intra-operative morbidity, anastomotic leakage, post-operative mortality, quality of mesorectal specimen, and resection margins. The main differences identified were a lower conversion rate for RS (RR=0.48 [0.24-0.95], p=0.04, I2=0%), and a longer operative time for RS (mean difference=39.11min [9.39-68.83], p<0.01, I2=96%). The other differences had no real clinical relevance, i.e., resumption of flatus passage (5hours earlier after RS), and lymph node dissection (one more lymph node for LS). CONCLUSION: This meta-analysis does not confirm the initial hypothesis and does not show a statistically significant or clinically relevant benefit of RS compared to LS for mid-low rectal cancer.

Impact of Daily Bedside Echocardiographic Assessment on Readmissions in Acute Heart Failure: A Randomized Clinical Trial.

Acute heart failure (AHF) management is challenging, with high morbidity and readmission rates. There is little evidence of the benefit of HF monitoring during hospitalization. The aim of the study was to assess whether daily bedside echocardiographic monitoring (JetEcho) improved outcomes in AHF. In this prospective, open, two parallel-arm study (clinicaltrials.gov: NCT02892227), participants from two university hospitals were randomized to either standard of care (SC) or daily treatment adjustment including diuretics guided by JetEcho evaluating left ventricular filling pressure and volemia. The primary outcome was 30-day readmission rate. Key secondary outcomes were six-month cumulative incidence death, worsening HF during hospitalization and increasing of myocardial and renal biomarkers. From 250 included patients, 115 were finally analyzed in JetEcho group and 112 in SC group. Twenty-two (19%) patients were readmitted within 30 days in JetEcho group and 17 (15%) in SC group (relative risk [RR] 1.26; 95% confidence interval [CI], 0.70−2.24; p = 0.4). Worsening HF occurred in 17 (14%) patients in the JetEcho group and 24 (20%) in the SC group (RR 0.7; 95% [CI] 0.39 to 1.2; p = 0.2). No significant difference was found between the two groups concerning natriuretic peptides and renal function (p > 0.05 for all). The cumulative incidence rate of death from any cause at six months from discharge was 8.7% in the JetEcho group and 11.6% in the SC group (HR 0.63, 95% [CI] 0.3−1.4, p = 0.3). In AHF patients, a systematic daily bedside echocardiographic monitoring did not reduce 30-day readmission rate for HF and short-term clinical outcomes.

Diaphragmatic excursion measurement in emergency department patients with acute dyspnea to predict mechanical ventilation use.

INTRODUCTION: Ultrasound is a feasible and reproducible method for measuring right diaphragmatic excursion (RDE) in ED patients with acute dyspnea (AD). In AD patients, the correlation between the RDE value and the need for mechanical ventilation (MV) is not known. MATERIALS: This was a bicentric, observational prospective study. The RDE measurement was done at admission. The need for MV was defined by the use of MV within 4 h of AD management. An optimal threshold for RDE was determined as the value that minimized the incorrect predictions of the use of MV in the first 4 h as the highest Youden index. RESULTS: We analyzed 102 patients (79 [70; 86] years), 38 (37%) of whom had been ventilated. The RDE value was 1.7 cm [1.4; 2.0] and 2.2 cm [1.8; 2.6] in the ventilated and non-ventilated groups, respectively (p = 0.06). The AUC was 0.68 95% CI [0.57; 0.80]. With a threshold of 2 cm, the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were 76% [60%; 89%], 59% [46%; 71%], 81% [67%; 91%], and 53% [39%; 66%], respectively. In the non-COPD patients, the RDE values were 1.5 cm [1.2; 1.9] and 2.2 cm [1.8; 2.6] (p < 0.01) in the ventilated and not-ventilated groups, respectively. The AUC was 0.77 95% CI [0.64; 0.90]. With a threshold of 2.18 cm, the sensitivity, specificity, NPV, and PPV were 91% [71%; 99%], 51% [36%; 66%], 92% [75%; 99%], and 54% [38%; 69%], respectively. CONCLUSION: The RDE values at ED admission were unable to define a prognostic threshold value associated with subsequent MV need in the AD patients. In non-COPD patients, the NPV was 92%.

Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel™ app and an original web platform for patients following outpatient surgery: a prospective observational pilot study.

BACKGROUND: Remote monitoring of mean arterial blood pressure (MAP), heart rate (HR) or oxygen saturation (SpO2) remains a challenge in outpatient surgery. This study evaluates a new digital technology (Smart Angel™) for remotely monitoring hemodynamic data in real time: data transmitted from the patient's home to a central server, using a dedicated web-based software package. METHODS: Adults scheduled for elective outpatient surgery were prospectively enrolled. In the first 5 postoperative days, patients completed a self-report questionnaire (pain, comfort, nausea, vomiting) and recorded SpO2, HR and MAP via two wireless Bluetooth monitors connected to a 4G tablet to transmit the data to a website, in real time, using Smart Angel™ software. Before transmission to the website, these data were also self-reported by the patient on a paper form. The primary outcome was the proportion of variables (self-monitored physiological data + questionnaire scores) correctly transmitted to the hospital via the system compared with the paper version. On Day 5, a system usability scale survey (SUS score 1-100) was also attributed. RESULTS: From May 2018 to September 2018, data were available for 29 out of 30 patients enrolled (1 patient was not discharged from hospital after surgery). The remote monitoring technology recorded 2038 data items (62%) compared with 2656 (82%) items recorded on the paper form (p = 0.001). The most common errors with the remote technology were software malfunctioning when starting the MAP monitor and malfunctioning between the tablet and the Bluetooth monitor. No serious adverse events were noted. The SUS score for the system was 85 (68-93) for 26 patients. CONCLUSION: This work evaluates the ability of a pilot system for monitoring remote physiological data using digital technology after ambulatory surgery and highlights the digital limitations of this technology. Technological improvements are required to reduce malfunctioning (4G access, transmission between apps). TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03464721 ) (March 8, 2018).

Results of API-AI based regimen in osteosarcoma adult patients included in the French OS2006/Sarcome-09 study.

In the OS2006 study, patients younger than 18 years were treated with a methotrexate-based regimen (MTX), patients older than 25 years with a doxorubicin-cisplatin-ifosfamide-based regimen (API-AI), whereas patients aged 18-25 years received either API-AI or MTX. We herein report the prespecified subgroup analysis of the outcome of 106 patients treated with API-AI. Preoperative chemotherapy combined three doxorubicin-ifosfamide-cisplatin (API) and two doxorubicin-ifosfamide (AI) courses. Postoperative chemotherapy was assigned by risk group: localised patients with a good histological response (<10% viable cells) received two AI and two cisplatin-ifosfamide (PI) courses; patients with synchronous metastases, poor histological response or unresectable primary received five cycles of etoposide-ifosfamide (EI). Of the 106 patients, 61 were randomised to receive or not zoledronate. Median age was 30 years (range 18-67), 66 (62%) patients were >25 years. The primary tumours were axial in 28 patients (26%), and 28 (26%) presented with metastases. Ninety-six patients (91%) had surgery, conservative in 82 (85%); 36 patients (38%, 95% CI 28-48%) were good responders. Toxicity was manageable, with no significant difference in severe acute toxicity between patients aged >25 years and those younger. With a median follow-up of 4.8 years, the 5-year event-free survival and overall survival rates were 46% (95% CI 36-56) and 57% (95% CI 47-67), respectively. The primary tumour size and initial metastases correlated with a higher risk of event. In these 106 osteosarcoma adult patients, API-AI proved feasible with no excess of toxicity, and favourable activity despite poor-prognosis factors.

Methotrexate-Etoposide-Ifosfamide Compared with Doxorubicin-Cisplatin-Ifosfamide Chemotherapy in Osteosarcoma Treatment, Patients Aged 18-25 Years.

Purpose: The French standard chemotherapy for osteosarcoma combines high-dose methotrexate (HDM) and etoposide-ifosfamide (EI) in children and adolescents, and API-AI (doxorubicin-cisplatin-ifosfamide) in adults. We herein present the results of M-EI and API-AI in 18- to 25-year-old patients. Methods: Patients, 18-25 years old, received either M-EI or API-AI regimens. M-EI comprised seven M and two EI doses preoperatively then M-EI in standard-risk patients (good histological response without metastasis) and five M-AP (methotrexate-doxorubicin-cisplatin) in high-risk patients (poor histological response, metastasis, and/or unresectable primary), postoperatively. API-AI comprised three API and two AI doses preoperatively, then two AI and two PI in standard-risk patients and five EI in high-risk patients, postoperatively. Results: We analyzed 95 patients 18-25 years of age: 55 received M-EI and 40 API-AI. The groups had similar baseline characteristics. Eighty-nine patients (94%) had surgery. Twenty-nine of 55 M-EI patients (60%) and 16/40 API-AI patients (41%) had good histological responses to preoperative chemotherapy. At 5 years, event-free survival was 50% (95% confidence interval [CI]: 39-60) and overall survival was 65% (95% CI: 54-74). Acute toxicity was similar, without treatment-related deaths. Conclusions: Survival outcomes with M-EI and API-AI were not significantly different. Tolerance was acceptable with both regimens. HDM is thus feasible for young adults. However, our study limitations preclude any definitive conclusions.

Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial.

BACKGROUND: Ultrasound (US) guidance has yet to prove its applicability in radial arterial blood gas analysis (ABGA) punctures. The main objective of our study was to compare the number of first-attempt successes (NFAS) for radial arterial puncture in difficult patients with or without US guidance. The Secondary aims were to compare the number of punctures (NOP), puncture time, and patient pain. METHODS: In this single-center, randomized controlled trial, patients who required a radial ABGA and in whom the arterial puncture was assessed as difficult (because of non-palpable radial arteries or two previous puncture failures by a nurse) were assigned to the US group or no-US (NUS) group (procedure performed by a trained physician). RESULTS: Thirty-six patients were included in the US group and 37 in the NUS groups. The NFAS was 7 (19%) in the NUS group and 19 (53%) in the US group. The relative risk of success in the US group was 2.79 (95% CI,1.34 to 5.82), p = 0.01. In the NUS and US groups, respectively, the median NOP was 3 [2; 6] vs. 1 [1; 2], estimated difference -2.0 (95%CI, -3.4 to -0.6), p < 0.01; the respective puncture time was 3.1 [1.6; 5.4] vs. 1.4 [0.6; 3.1] min, estimated difference -1.45 (95%CI, -2.57 to -0.39), p = 0.01; the respective median patient pain was 6 [4; 8] vs. 2 [1; 4], estimated difference -4.0 (95%CI, -5.8 to -2.3); p < 0.01. CONCLUSION: US guidance by a trained physician significantly improves the rate of success in difficult radial ABGA patients.

Results of methotrexate-etoposide-ifosfamide based regimen (M-EI) in osteosarcoma patients included in the French OS2006/sarcome-09 study.

BACKGROUND: In most countries, reference chemotherapy for osteosarcoma is MAP regimen (M = high-dose methotrexate, AP = doxorubicin-cisplatinum). In France, the standard preoperative chemotherapy for children/adolescents combines M and etoposide-ifosfamide (EI), based on the OS94-trial. We report the safety and efficacy results of patients ≤25 years treated with preoperative M-EI regimen enroled in the French OS2006-study, between 2007 and 2014. METHODS: Treatment comprised preoperative chemotherapy with the 7 M-courses and 2 EI-courses, then surgery and postoperative chemotherapy assigned by risk's groups: standard-risk (good histological response without metastases) received 12 M-courses, 3 EI-courses; high-risk (poor histologic response, initial metastases or unresectable primary) received 5 M-courses alternated with 5 AP-courses. 253 patients were randomised to receive (n = 128) or not (n = 125) zoledronate. RESULTS: 409/522 patients enroled in the OS2006 study who received preoperative M-EI were analysed. Median age was 14.3 years (4.7-24.5), with 55 patients aged 18-25 years. Primary tumour location was limb in 383 patients (94%) and 85 (21%) presented metastases. Median chemotherapy duration was 37.4 weeks. 381 (96%) patients underwent surgery, 258 patients (65%) had a good histologic response. 187/324 patients (58%) with localised disease did not receive doxorubicin nor cisplatinum. Toxicity was evaluated in the randomised study: most patients experienced ≥1 severe toxicity (grade IV haematological or grade III/IV extra-haematological). Median follow-up was 4.8 years, and 168 patients had events. Five-year event-free survival was 56% (95% CI, 51-62%) and overall survival 71% (66-76%). CONCLUSION: M-EI regimen/strategy was feasible for patient aged ≤25 years with survival rates are comparable to those obtained with MAP regimen.