This website is for US healthcare professionals


Log In to Bolder Science


Don't have an account? Sign Up


Please enter your email address.

You will receive a link to create a new password via email.

Log In


Create an Account

  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

Prevalence of Malnutrition in Surgery

  • identifier


  • Recruitment Status


  • 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: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)


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


Contact: Maurizio Muscaritoli (+39) 06 845431

Contact: Simona Saracco (+39) 06 845431


Pof. Romario Fumagalli

Leonardo De Meo

Claudio Pedrazzi
Reggio Emilia

Roberto Coppola

Antonio Gasbarrini

Roberto Caronna

Amilcare Parisi

Giovanni de Manzoni

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


Principal Investigator: Roberto Coppola Campus Bio-Medico of Rome

More Information