RESUMO
BACKGROUND: Colon cancer (CC) is a public health concern with increasing incidence in younger populations. Treatment for locally advanced CC (LACC) involves oncological surgery and adjuvant chemotherapy (AC) to reduce recurrence and improve overall survival (OS). Neoadjuvant chemotherapy (NAC) is a novel approach for the treatment of LACC, and research is underway to explore its potential benefit in terms of survival. This trial will assess the efficacy of NAC in LACC. METHODS: This is a multicentre randomised, parallel-group, open label controlled clinical trial. Participants will be selected based on homogenous inclusion criteria and randomly assigned to two treatment groups: NAC, surgery, and AC or surgery followed by AC. The primary aim of this study is to evaluate the 2-year progression-free survival (PFS), with secondary outcomes including 5-year PFS, 2- and 5-year OS, toxicity, radiological and pathological response, morbidity, and mortality. DISCUSSION: The results of this study will determine whether NAC induces a clinical and histological tumour response in patients with CCLA and if this treatment sequence improves survival without increasing morbidity and mortality. REGISTRATION NUMBER: NCT04188158.
Assuntos
Neoplasias do Colo , Terapia Neoadjuvante , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimioterapia Adjuvante/métodos , Colectomia/métodos , Neoplasias do Colo/patologia , Neoplasias do Colo/mortalidade , Neoplasias do Colo/tratamento farmacológico , Neoplasias do Colo/terapia , Neoplasias do Colo/cirurgia , Terapia Neoadjuvante/métodos , Intervalo Livre de Progressão , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: As the population ages, more older adults are presenting for surgery. Age-related declines in physiological reserve and functional capacity can result in frailty and poor outcomes after surgery. Hence, optimizing perioperative care in older patients is imperative. Enhanced Recovery After Surgery (ERAS) pathways and Minimally Invasive Surgery (MIS) may influence surgical outcomes, but current use and impact on older adults patients is unknown. The aim of this study was to provide evidence-based recommendations on perioperative care of older adults undergoing major abdominal surgery. METHODS: Expert consensus determined working definitions for key terms and metrics related to perioperative care. A systematic literature review and meta-analysis was performed using the PubMed, Embase, Cochrane Library, and Clinicaltrials.gov databases for 24 pre-defined key questions in the topic areas of prehabilitation, MIS, and ERAS in major abdominal surgery (colorectal, upper gastrointestinal (UGI), Hernia, and hepatopancreatic biliary (HPB)) to generate evidence-based recommendations following the GRADE methodology. RESULT: Older adults were defined as 65 years and older. Over 20,000 articles were initially retrieved from search parameters. Evidence synthesis was performed across the three topic areas from 172 studies, with meta-analyses conducted for MIS and ERAS topics. The use of MIS and ERAS was recommended for older adult patients particularly when undergoing colorectal surgery. Expert opinion recommended prehabilitation, cessation of smoking and alcohol, and correction of anemia in all colorectal, UGI, Hernia, and HPB procedures in older adults. All recommendations were conditional, with low to very low certainty of evidence, with the exception of ERAS program in colorectal surgery. CONCLUSIONS: MIS and ERAS are recommended in older adults undergoing major abdominal surgery, with evidence supporting use in colorectal surgery. Though expert opinion supported prehabilitation, there is insufficient evidence supporting use. This work has identified evidence gaps for further studies to optimize older adults undergoing major abdominal surgery.
Assuntos
Medicina Baseada em Evidências , Assistência Perioperatória , Humanos , Idoso , Assistência Perioperatória/métodos , Assistência Perioperatória/normas , Recuperação Pós-Cirúrgica Melhorada , Consenso , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Idoso de 80 Anos ou maisAssuntos
Anastomose Cirúrgica , Hepatectomia , Protectomia , Neoplasias Retais , Procedimentos Cirúrgicos Robóticos , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Neoplasias Retais/cirurgia , Neoplasias Retais/patologia , Hepatectomia/métodos , Anastomose Cirúrgica/métodos , Protectomia/métodos , Estadiamento de Neoplasias , Masculino , Pessoa de Meia-IdadeRESUMO
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Assuntos
Humanos , Feminino , Pessoa de Meia-Idade , Colo/anormalidades , Colonoscopia , Variação Anatômica , Fatores de RiscoRESUMO
BACKGROUND: the Enhanced Recovery After Surgery (ERAS) protocols aim to improve postoperative outcomes by obtaining a functional rehabilitation after surgery. The purpose of this study was to evaluate the impact of ERAS on the quality of life (QOL) of patients undergoing colorectal cancer surgeries. METHODS: a cohort observational study was designed of patients with colorectal cancer undergoing elective surgeries during a one-year period. Patients were included when the ERAS protocol was fully achieved for all the interventions, including the expected hospital discharge day. Patient reported outcomes (PROs) were evaluated by the EORTC QLQ-C30 and the QLQ-CR29 questionnaires on three different occasions: baseline before surgery and on postoperative days 7 and 30. RESULTS: the study included 40 patients who completed QOL evaluations with a mean age of 70 ± 11 years. There were no statistical differences between preoperative and postoperative QOL scores. By subgroups of QOL items, a significant decrease was observed in physical activity and role functioning when comparing preoperative vs postoperative status, whereas the cognitive, social and emotional functioning scales were similar or improved over time. CONCLUSIONS: in our experience, surgery under ERAS protocols did not have an impact on decreasing global QOL in patients undergoing elective colorectal cancer surgery. The use of ERAS protocols in colorectal surgery achieves a positive influence, not only by decreasing surgical-related complications but also in terms of functional recovery, by decreasing the negative effects of surgery on patient QOL
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Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Neoplasias Colorretais/psicologia , Neoplasias Colorretais/cirurgia , Assistência Perioperatória/métodos , Cuidados Pós-Operatórios , Qualidade de Vida , Estudos Prospectivos , Estudos de CoortesRESUMO
Background: the incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study evaluates the correlation between obstetric injuries detected by endoanal ultrasound (3D-EUS) and AI symptoms, as well as their impact on the quality of life (QOL) of women after childbirth. Methods: a prospective observational study was performed of pregnant women evaluated before (baseline) and three months after childbirth to ensure the integrity of the anal sphincters and to evaluate possible injuries. The Fecal Incontinence Quality of Life (FIQL) questionnaire and the Cleveland Clinic Score of Incontinence (Wexner) were completed before and after childbirth. The questionnaire results were correlated with an assessment of sphincter defects performed by 3D-EUS. Results: a total of 56 females were included in the study. Overall, 48% developed symptoms of AI after childbirth, with a significant decrease in their FIQL compared to the initial evaluation, 3.9 (0.05) vs 3.4 (0.8), respectively (p = 0.000). In addition, 42% of the cohort presented with some kind of obstetric sphincter defect on the 3D-EUS. Instrumental assisted delivery and the sphincter defects were the only two significant factors identified via multivariate analysis that were associated with a decrease in QOL (0.4, 95% CI, 0.07-0.8). Conclusions: AI after childbirth was associated with a huge impact on QOL, especially in patients with sphincter injuries. A complete clinical evaluation, including 3D-EUS, is recommended to prevent, manage or treat AI in primiparous females
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