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出境医 / 临床实验 / Prevalence of Malnutrition in Surgery (PROMIS)

Prevalence of Malnutrition in Surgery (PROMIS)

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 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.

Study Design
Layout table for study information
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
Arms and Interventions
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
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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.
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Roberto Coppola Campus Bio-Medico of Rome
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 *
  • Garcia GH, Fu MC, Dines DM, Craig EV, Gulotta LV. Malnutrition: a marker for increased complications, mortality, and length of stay after total shoulder arthroplasty. J Shoulder Elbow Surg. 2016 Feb;25(2):193-200. doi: 10.1016/j.jse.2015.07.034. Epub 2015 Oct 9.
  • Culebras JM. Malnutrition in the twenty-first century: an epidemic affecting surgical outcome. Surg Infect (Larchmt). 2013 Jun;14(3):237-43. doi: 10.1089/sur.2013.9993. Epub 2013 May 15.
  • Mahdi H, Jernigan AM, Aljebori Q, Lockhart D, Moslemi-Kebria M. The impact of obesity on the 30-day morbidity and mortality after surgery for endometrial cancer. J Minim Invasive Gynecol. 2015 Jan;22(1):94-102. doi: 10.1016/j.jmig.2014.07.014. Epub 2014 Jul 24.
  • Hébuterne X, Lemarié E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674.
  • Ejaz A, Spolverato G, Kim Y, Poultsides GA, Fields RC, Bloomston M, Cho CS, Votanopoulos K, Maithel SK, Pawlik TM. Impact of body mass index on perioperative outcomes and survival after resection for gastric cancer. J Surg Res. 2015 May 1;195(1):74-82. doi: 10.1016/j.jss.2014.12.048. Epub 2014 Dec 31.
  • Muscaritoli M, Molfino A, Gioia G, Laviano A, Rossi Fanelli F. The "parallel pathway": a novel nutritional and metabolic approach to cancer patients. Intern Emerg Med. 2011 Apr;6(2):105-12. doi: 10.1007/s11739-010-0426-1. Epub 2010 Jul 2. Review.
  • Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.
  • Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. Review.
  • Muscaritoli M, Anker SD, Argilés J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
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 information is only displayed when the study is recruiting subjects
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

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