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| Name | Class |
|---|---|
| Campus Bio-Medico University | OTHER |
| University of Roma La Sapienza | OTHER |
| Catholic University of the Sacred Heart | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional status | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Malnutrition | Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST) | Pre-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative complications | Incidence of pneumonia, sepsis and dehiscence of the surgical wound. | Hospital discharge (10-15 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurizio Muscaritoli | Contact | (+39) 06 845431 | segreteria@sinuc.it | |
| Simona Saracco | Contact | (+39) 06 845431 |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Coppola | Campus Bio-Medico of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pof. Romario Fumagalli | Recruiting | Brescia | Italy | |||
| Leonardo De Meo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26456427 | Result | 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. | |
| 23676121 | Result | 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. No abstract available. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| Recruiting |
| Catania |
| Italy |
| Claudio Pedrazzi | Recruiting | Reggio Emilia | Italy |
| Roberto Coppola | Recruiting | Rome | 00198 | Italy |
|
| Antonio Gasbarrini | Recruiting | Rome | Italy |
| Roberto Caronna | Recruiting | Rome | Italy |
| Amilcare Parisi | Recruiting | Terni | Italy |
| Giovanni de Manzoni | Recruiting | Verona | Italy |
| 25064420 | Result | 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. |
| 24748626 | Result | Hebuterne X, Lemarie 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. |
| 25619462 | Result | 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. |
| 20596799 | Result | 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. |
| 25799486 | Result | 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. |
| 21296615 | Result | 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. |
| 20060626 | Result | Muscaritoli M, Anker SD, Argiles 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. |
| D003710 | Demography |
| D011154 | Population Characteristics |