Phase II trial to evaluate combination of folfox6 + bevacizumab in initially unresectable liver metastases from colorectal cancer (crc)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14603-14603 ◽  
Author(s):  
N. Malavasi ◽  
C. Dealis ◽  
R. Depenni ◽  
S. Zironi ◽  
F. Bertolini ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Liver Metastases ◽  
Elective Surgery ◽  
Primary Objective ◽  
Pet Scan ◽  
Major Surgery ◽  
Surgery Complications ◽  
Patient Reported ◽  
Life Threatening ◽  
Combination Regimens

14603 Introduction: The gold standard treatment of CRC liver metastases is surgical resection. Bevacizumab has proved efficacy in advanced disease. Primary objective of the study is to evaluate resecability rate of liver metastases and incidence of major surgery complications. Secondary objective is to relate tumor and serum biomarkers (EGFR, VEGF, TS, Ki67, ERCC1, MSH2, MLH1 and VEGF ) to clinical outcome Methods: Baseline requires evaluation by CT-PET scan, biopsy of metastases; PET scan is needed after first administration to describe preliminary response. The treatment consists of FOLFOX6 regimen associated to Bevacizumab, 5mg/Kg, every two weeks; elective surgery is planned after 6 cycles (the last one excludes Bevacizumab dose) by CT-PET scan; if resection is appropriate, it will be performed, otherwise the treatment will continue to 12 cycles. Biomarkers are assessed at baseline, following the first administration and before surgery Results: Up to now 11 patients have been enrolled (M/F:6/5; median age:64, range:46–72); ECOG: 0/1. 10 patients reached surgical step while 1 patient is still on chemotherapy. Three patients (27%) were not suitable for resection and received further chemotherapy: 1 had PR, 1 PD and 1 became resectable after 12 cycles. In the other 7 patients (63%): 2 CR (18%) histologically confirmed; 4 macroscopic and curative resection of liver metastasis; 1 is receving two stage epathectomy (portal vein occlusion before major liver resection). Life threatening toxicities: 1 TVP causing discontinuation of Bevacizumab, 1 hospitalization for gastro-intestinal and G4 neutropenia both causing discontinuation of the whole therapy. Bevacizumab complications before major surgery did not occurred; 1 patient reported post operative delay wound healing. Less severe toxicities: haematological G3 in 2 patients (18%), G1 in 1 patient (9%); 3 gastrointestinal G2 (27%); neuropathic in 1 patient (9%). The VEGF serum decreased after the first dose of Bevacizumab in all specimens Conclusions: Systemic chemotherapy with combination regimens may downstage liver metastases and thus increase resecability rate without important surgery complications; biomarkers related to clinical outcome are in evaluation. No significant financial relationships to disclose.

scholarly journals Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e036568
Author(s):  
Sebastian T Lugg ◽  
Amy Kerr ◽  
Salma Kadiri ◽  
Alina-Maria Budacan ◽  
Amanda Farley ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Pilot Study ◽  
Thoracic Surgery ◽  
Elective Surgery ◽  
Primary Objective ◽  
Pulmonary Complications ◽  
University Hospitals ◽  
Patient Reported ◽  
Ethical Approval ◽  
Surgical Pathway

IntroductionSmoking prior to major thoracic surgery is the biggest risk factor for development of postoperative pulmonary complications, with one in five patients continuing to smoke before surgery. Current guidance is that all patients should stop smoking before elective surgery yet very few are offered specialist smoking cessation support. Patients would prefer support within the thoracic surgical pathway. No study has addressed the effectiveness of such an intervention in this setting on cessation. The overall aim is to determine in patients who undergo major elective thoracic surgery whether an intervention integrated (INT) into the surgical pathway improves smoking cessation rates compared with usual care (UC) of standard community/hospital based NHS smoking support. This pilot study will evaluate feasibility of a substantive trial.Methods and analysisProject MURRAY is a trial comparing the effectiveness of INT and UC on smoking cessation. INT is pharmacotherapy and a hybrid of behavioural support delivered by the trained healthcare practitioners (HCPs) in the thoracic surgical pathway and a complimentary web-based application. This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust. The primary objective is to establish the proportion of those eligible who agree to participate. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.Ethics and disseminationThe study has obtained ethical approval from NHS Research Ethics Committee (REC number 19/WM/0097). Dissemination plan includes informing patients and HCPs; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full application dependent on the success of the study.Trial registration numberNCT04190966.

scholarly journals Assessing change in patient-reported quality of life after elective surgery: protocol for an observational comparison study

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 976 ◽  
Author(s):  
Vanessa L. Kronzer ◽  
Michelle R. Jerry ◽  
Michael S. Avidan
Keyword(s):  
Quality Of Life ◽  
Elective Surgery ◽  
Minimum Clinically Important Difference ◽  
Primary Objective ◽  
Patient Decision Making ◽  
Study Protocols ◽  
Patient Decision ◽  
Patient Reported ◽  
Assess Quality

Despite their widespread use, the two main methods of assessing quality of life after surgery have never been directly compared. To support patient decision-making and study design, we aim to compare these two methods. The first of these methods is to assess quality of life before surgery and again after surgery using the same validated scale. The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. Our primary objective is to assess agreement between the two measures. Secondary objectives are to calculate the minimum clinically important difference (MCID) and to describe the variation across surgical specialties. To accomplish these aims, we will administer surveys to patients undergoing elective surgery, both before surgery and again 30 days after surgery. This protocol follows detailed guidelines for observational study protocols.

scholarly journals Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study

2021 ◽  
pp. 219256822098827
Author(s):  
Scott L. Zuckerman ◽  
Meghan Cerpa ◽  
Lawrence G. Lenke ◽  
Christopher I. Shaffrey ◽  
Leah Y. Carreon ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Adult Spinal Deformity ◽  
Corrective Osteotomy ◽  
Leg Pain ◽  
Major Surgery ◽  
Mean Values ◽  
Self Image ◽  
Patient Reported ◽  
Spinal Deformity Surgery

Study Design: Prospective cohort. Objective: To prospectively evaluate PROs up to 5-years after complex ASD surgery. Methods: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures. Results: Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values ( P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without. Conclusions: After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.

scholarly journals Decision Making from the Experience of Orthognathic Surgery Patients: A Grounded Theory Approach

2021 ◽  
pp. 238008442110144
Author(s):  
N.R. Paul ◽  
S.R. Baker ◽  
B.J. Gibson
Keyword(s):  
Decision Making ◽  
Grounded Theory ◽  
Treatment Options ◽  
Study Data ◽  
Primary Objective ◽  
Major Surgery ◽  
Future Research ◽  
Decision Making Process ◽  
Theory Approach

Introduction: Patients’ decisions to undergo major surgery such as orthognathic treatment are not just about how the decision is made but what influences the decision. Objectives: The primary objective of the study was to identify the key processes involved in patients’ experience of decision making for orthognathic treatment. Methods: This study reports some of the findings of a larger grounded theory study. Data were collected through face-to-face interviews of patients who were seen for orthognathic treatment at a teaching hospital in the United Kingdom. Twenty-two participants were recruited (age range 18–66 y), of whom 12 (male = 2, female = 10) were 6 to 8 wk postsurgery, 6 (male = 2, female = 4) were in the decision-making stage, and 4 (male = 0, female = 4) were 1 to 2 y postsurgery. Additional data were also collected from online blogs and forums on jaw surgery. The data analysis stages of grounded theory methodology were undertaken, including open and selective coding. Results: The study identified the central role of dental care professionals (DCPs) in several underlying processes associated with decision making, including legitimating, mediating, scheduling, projecting, and supporting patients’ decisions. Six categories were related to key aspects of decision making. These were awareness about their underlying dentofacial problems and treatment options available, the information available about the treatment, the temporality of when surgery would be undertaken, the motivations and expectation of patients, social support, and fear of the surgery, hospitalization, and potentially disliking their new face. Conclusion: The decision-making process for orthognathic treatment is complex, multifactorial, and heavily influenced by the role of DCPs in patient care. Understanding the magnitude of this role will enable DCPs to more clearly participate in improving patients’ decision-making process. The findings of this study can inform future quantitative studies. Knowledge Transfer Statement: The results of this study can be used both for informing clinical practice around enabling decision making for orthognathic treatment and also for designing future research. The findings can better inform clinicians about the importance of their role in the patients’ decision-making process for orthognathic treatment and the means to improve the patient experience. It is suggested that further research could be conducted to measure some of the key constructs identified within our grounded theory and assess how these change during the treatment process.

scholarly journals Experiences of a “COVID protected” robotic surgical centre for colorectal and urological cancer in the COVID-19 pandemic

2021 ◽  
Author(s):  
Jeremy R. Huddy ◽  
Matthew Crockett ◽  
A Shiyam Nizar ◽  
Ralph Smith ◽  
Manar Malki ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Robotic Surgery ◽  
Length Of Stay ◽  
Elective Surgery ◽  
Standard Operating Procedure ◽  
Major Surgery ◽  
Renal Surgery ◽  
Increased Risk ◽  
Acute Hospitals ◽  
Da Vinci Si

AbstractThe recent COVID-19 pandemic led to the cancellation of elective surgery across the United Kingdom. Re-establishing elective surgery in a manner that ensures patient and staff safety has been a priority. We report our experience and patient outcomes from setting up a “COVID protected” robotic unit for colorectal and renal surgery that housed both the da Vinci Si (Intuitive, Sunnyvale, CA, USA) and the Versius (CMR Surgical, Cambridge, UK) robotic systems. “COVID protected” robotic surgery was undertaken in a day-surgical unit attached to the main hospital. A standard operating procedure was developed in collaboration with the trust COVID-19 leadership team and adapted to national recommendations. 60 patients underwent elective robotic surgery in the initial 10-weeks of the study. This included 10 colorectal procedures and 50 urology procedures. Median length of stay was 4 days for rectal cancer procedures, 2 days less than prior to the COVID period, and 1 day for renal procedures. There were no instances of in-patient coronavirus transmission. Six rectal cancer patients waited more than 62 days for their surgery because of the initial COVID peak but none had an increase T-stage between pre-operative staging and post-operative histology. Robotic surgery can be undertaken in “COVID protected” units within acute hospitals in a safe way that mitigates the increased risk of undergoing major surgery in the current pandemic. Some benefits were seen such as reduced length of stay for colorectal patients that may be associated with having a dedicated unit for elective robotic surgical services.

scholarly journals Best versus worst surgical outcomes after single-level posterior lumbar interbody fusion for degenerative spondylolisthesis

2021 ◽  
Vol 29 (1) ◽  
pp. 230949902098303
Author(s):  
Se-Jun Park ◽  
Keun-Ho Lee ◽  
Chong-Suh Lee ◽  
Ki-Tack Kim ◽  
Dong Hyeon Kim ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Interbody Fusion ◽  
Lumbar Fusion ◽  
Degenerative Spondylolisthesis ◽  
Individual Treatment ◽  
Symptom Duration ◽  
Lumbar Interbody Fusion ◽  
Characteristic Analysis ◽  
Single Level ◽  
Patient Reported

Purpose: Previous studies have shown conflicting results regarding the factors affecting the clinical outcome after fusion for degenerative spondylolisthesis. However, no study has compared the best and worst clinical outcome groups using patient-reported outcome measures. We aimed to compare the characteristics of patients with best and worst outcomes following single-level lumbar fusion for degenerative spondylolisthesis. Methods: 200 patients underwent single-level interbody fusion with a minimum 2-years follow-up were included. We excluded patients with surgical complications already-known to be associated with poor postoperative outcomes, including pseudoarthrosis and postoperative infection. According to 2-year postoperative Oswestry disability index scores, patients were divided into two groups; Best and Worst. Demographic, clinical and radiographic variables were compared between the two groups. Results: Compared with patients in the Best group, those in the Worst group were older (59.5 and 67.0 years, respectively; p = 0.012; odds ratio [OR], 1.143; 95% confidence interval [CI], 1.030–1.269) and had a longer duration of pain from onset (2.6 and 7.2 years, respectively; p = 0.041; OR, 1.021; 95% CI, 1.001–1.041). The cutoff value of pain duration from onset was measured as ≥3.5 years on Receiver operating characteristic analysis. Patients in the Worst group had a lower preoperative angular motion compared to those in the Best group (12.7° and 8.3°, respectively; p = 0.016; OR, 0.816; 95% CI, 0.691–0.963). Conclusions: Degenerative spondylolisthesis patients of good clinical outcome after single-level lumbar interbody fusion were relatively young, had a short symptom duration before surgery, and a high preoperative instability compared with the patient having poor postoperative clinical outcome. Therefore, these findings should be considered preoperatively when deciding the appropriate individual treatment plan.

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