Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date March 17, 2018
First Posted Date April 24, 2019
Last Update Posted Date April 24, 2019
Actual Study Start Date January 6, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
Malnutrition [ Time Frame: Pre-operative ]
Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 23, 2019)
Post-operative complications [ Time Frame: Hospital discharge (10-15 days) ]
Incidence of pneumonia, sepsis and dehiscence of the surgical wound.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Malnutrition in Surgery
Official Title Prevalence of Malnutrition in Surgery
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Malnutrition
  • Surgery
  • Cancer
Intervention Other: Nutritional status
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2019)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Maurizio Muscaritoli (+39) 06 845431 segreteria@sinuc.it
Contact: Simona Saracco (+39) 06 845431
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03926715
Other Study ID Numbers 01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Società Italiana di Nutrizione Clinica e Metabolismo
Study Sponsor Società Italiana di Nutrizione Clinica e Metabolismo
Collaborators
  • 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
PRS Account Società Italiana di Nutrizione Clinica e Metabolismo
Verification Date April 2019