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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Prevalence of Malnutrition in Surgery

Clinicaltrials.gov identifier NCT03926715

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

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:Cancer
    Malnutrition
    Surgery
  • Intervention/Treatment: Other: Nutritional status
  • Phase: N/A
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.

Study Design
  • 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 2017
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: December 2019
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • 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.

Contacts and Locations
Contacts

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

Contact: Simona Saracco (+39) 06 845431

Locations

Italy
Pof. Romario Fumagalli
Brescia

Italy
Leonardo De Meo
Catania

Italy
Claudio Pedrazzi
Reggio Emilia

Italy
Roberto Coppola
Rome

Italy
Antonio Gasbarrini
Rome

Italy
Roberto Caronna
Rome

Italy
Amilcare Parisi
Terni

Italy
Giovanni de Manzoni
Verona

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

Principal Investigator: Roberto Coppola Campus Bio-Medico of Rome

More Information