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1.
Trials ; 25(1): 588, 2024 Sep 04.
Artículo en Inglés | MEDLINE | ID: mdl-39232781

RESUMEN

BACKGROUND: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking. METHODS: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. DISCUSSION: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05180864. Registered on 6th January 2022.


Asunto(s)
Estudios de Equivalencia como Asunto , Gastrectomía , Estudios Multicéntricos como Asunto , Epiplón , Neoplasias Gástricas , Humanos , Epiplón/cirugía , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Gastrectomía/efectos adversos , Gastrectomía/métodos , Resultado del Tratamiento , Factores de Tiempo , Calidad de Vida , Adulto , Ensayos Clínicos Controlados Aleatorios como Asunto , Masculino , Persona de Mediana Edad , Femenino , Anciano , Escisión del Ganglio Linfático/efectos adversos , Tratamientos Conservadores del Órgano/métodos , Tratamientos Conservadores del Órgano/efectos adversos , Supervivencia sin Enfermedad
2.
Ann Surg ; 276(6): e758-e763, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33351483

RESUMEN

OBJECTIVE: To determine the incremental yield of standardized addition of chest CT to abdominal CT to detect COVID-19 in patients presenting with primarily acute gastrointestinal symptoms requiring abdominal imaging. Summary Background Data: Around 20% of patients with COVID-19 present with gastrointestinal symptoms. COVID-19 might be neglected in these patients, as the focus could be on finding abdominal pathology. During the COVID-19 pandemic, several centers have routinely added chest CT to abdominal CT to detect possible COVID-19 in patients presenting with gastrointestinal symptoms. However, the incremental yield of this strategy is unknown. METHODS: This multicenter study in 6 Dutch centers included consecutive adult patients presenting with acute nontraumatic gastrointestinal symptoms, who underwent standardized combined abdominal and chest CT between March 15, 2020 and April 30, 2020. All CT scans were read for signs of COVID-19 related pulmonary sequelae using the СО-RADS score. The primary outcome was the yield of high COVID-19 suspicion (СО-RADS 4-5) based on chest CT. RESULTS: A total of 392 patients were included. Radiologic suspicion for COVID-19 (СО-RADS 4-5) was present in 17 (4.3%) patients, eleven of which were diagnosed with COVID-19. Only 5 patients with СО-RADS 4-5 presented without any respiratory symptoms and were diagnosed with COVID-19. No relation with community prevalence could be detected. CONCLUSION: The yield of adding chest CT to abdominal CT to detect COVID-19 in patients presenting with acute gastrointestinal symptoms is extremely low with an additional detection rate of around 1%.


Asunto(s)
COVID-19 , Enfermedades Gastrointestinales , Adulto , Humanos , COVID-19/diagnóstico por imagen , Pandemias , Tórax/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Enfermedades Gastrointestinales/diagnóstico por imagen
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