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Prevalence of Malnutrition in Surgery (PROMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926715
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Campus Bio-Medico University
University of Roma La Sapienza
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Società Italiana di Nutrizione Clinica e Metabolismo

Brief Summary:
Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

Condition or disease Intervention/treatment
Malnutrition Surgery Cancer Other: Nutritional status

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition




Primary Outcome Measures :
  1. Malnutrition [ Time Frame: Pre-operative ]
    Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)


Secondary Outcome Measures :
  1. Post-operative complications [ Time Frame: Hospital discharge (10-15 days) ]
    Incidence of pneumonia, sepsis and dehiscence of the surgical wound.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
Criteria

Inclusion Criteria:

  • Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
  • Diagnosis of malignant solid tumor
  • Age> 18 years
  • Informed consent

Exclusion Criteria:

  • Uncontrolled metabolic disorders
  • Uncompensated heart failure
  • Severe psychiatric disorders
  • Appropriate logistical support for participation in the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Maurizio Muscaritoli (+39) 06 845431 segreteria@sinuc.it
Contact: Simona Saracco (+39) 06 845431

Locations
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Italy
Pof. Romario Fumagalli Recruiting
Brescia, Italy
Leonardo De Meo Recruiting
Catania, Italy
Claudio Pedrazzi Recruiting
Reggio Emilia, Italy
Roberto Coppola Recruiting
Rome, Italy, 00198
Contact: Roberto Coppola       r.coppola@unicampus.it   
Antonio Gasbarrini Recruiting
Rome, Italy
Roberto Caronna Recruiting
Rome, Italy
Amilcare Parisi Recruiting
Terni, Italy
Giovanni de Manzoni Recruiting
Verona, Italy
Sponsors and Collaborators
Società Italiana di Nutrizione Clinica e Metabolismo
Campus Bio-Medico University
University of Roma La Sapienza
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Roberto Coppola Campus Bio-Medico of Rome
Publications of Results:

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Responsible Party: Società Italiana di Nutrizione Clinica e Metabolismo
ClinicalTrials.gov Identifier: NCT03926715    
Other Study ID Numbers: 01
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Società Italiana di Nutrizione Clinica e Metabolismo:
Malnutrition
Post-operative complication
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders