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Prevalence of Malnutrition in Surgery

Prevalence of Malnutrition in Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03926715
Acronym
PROMIS
Enrollment
700
Registered
2019-04-24
Start date
2017-01-06
Completion date
2019-12-31
Last updated
2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Malnutrition, Surgery

Keywords

Malnutrition, Post-operative complication

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.

Interventions

OTHERNutritional status

Sponsors

Campus Bio-Medico University
CollaboratorOTHER
University of Roma La Sapienza
CollaboratorOTHER
Catholic University of the Sacred Heart
CollaboratorOTHER
Società Italiana di Nutrizione Clinica e Metabolismo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
MalnutritionPre-operativeMalnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)

Secondary

MeasureTime frameDescription
Post-operative complicationsHospital discharge (10-15 days)Incidence of pneumonia, sepsis and dehiscence of the surgical wound.

Countries

Italy

Contacts

Primary ContactMaurizio Muscaritoli
segreteria@sinuc.it(+39) 06 845431
Backup ContactSimona Saracco
(+39) 06 845431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026