Prevalence of Malnutrition in Surgery (PROMIS)
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|ClinicalTrials.gov Identifier: NCT03926715|
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment|
|Malnutrition Surgery Cancer||Other: Nutritional status|
Nutritional disorders are highly prevalent in cancer patients and have shown to contribute significantly in short-, mid- and long-term clinical outcome. The prevalence of malnutrition is reported between 25% and over 70% based on nutritional assessments. Nutritional disorders represent an important risk factor for the occurence of postoperative complications.
Main obstacles to improving nutritional care include lack of awareness for the problem among the general public and lack of awareness among decision makers and even care providers.
Considering the high prevalence of malnutrition and its repercussions in patient morbidity-mortality and healthcare cost, nutritional screening measures must be included in an integrated nutritional care plan for patients before surgery and while in the hospital.
The PRoMiS study was conceived to quantify nutritional disorders among gastrointestinal cancer patients undergoing surgery in Italy. The data obtained will contribute to increase the awareness of nutritional disorders among oncology surgical patients and their impact on clinical outcome, favoring the inclusion of the initial assessment of nutritional status before surgery and of the nutritional intervention.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Prevalence of Malnutrition in Surgery|
|Actual Study Start Date :||January 6, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Malnutrition [ Time Frame: Pre-operative ]Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)
- Post-operative complications [ Time Frame: Hospital discharge (10-15 days) ]Incidence of pneumonia, sepsis and dehiscence of the surgical wound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926715
|Contact: Maurizio Muscaritoli||(+39) 06 firstname.lastname@example.org|
|Contact: Simona Saracco||(+39) 06 845431|
|Pof. Romario Fumagalli||Recruiting|
|Leonardo De Meo||Recruiting|
|Reggio Emilia, Italy|
|Rome, Italy, 00198|
|Contact: Roberto Coppola email@example.com|
|Giovanni de Manzoni||Recruiting|
|Principal Investigator:||Roberto Coppola||Campus Bio-Medico of Rome|