NCT03315195

Brief Summary

Surgical outcome is associated the nutritional status of the patients. Perioperative nutritional supplement for malnutritional patient were recommended. There are several guidelines were recommended the perioperative nutrition for malnutrition patients. But in our hospital, there are no consensus guideline applied for the clinical practice. The nutritional supplement was judged by only attending physical This study was conducted to comparing the perioperative nutritional supplement with oral supplement with conventional approach with only dietary advice alone for all patients who undergoing major gastrointestinal surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 25, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3.9 years

First QC Date

October 5, 2017

Last Update Submit

February 18, 2020

Conditions

Surgery--ComplicationsNutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Number of complications

    30 days after operation

Study Arms (2)

Preoperative oral nutritional supplement

EXPERIMENTAL

Oral nutritional supplement 500 kcal/day for 14 days and dietary advice

Dietary Supplement: Oral nutritional supplement (ONS)

Conventional treatment

NO INTERVENTION

Dietary advice

Interventions

Oral nutritional supplement (ONS)DIETARY_SUPPLEMENT

ONS supplement by 500 kcal/day for 14 days

Also known as: Nutren
Preoperative oral nutritional supplement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 year
  • undergoing major gastrointestinal surgery
  • able to take oral diet

You may not qualify if:

  • unable to take oral diet
  • Gastrointestinal tract insufficiency eg. gastrointestinal obstruction, perforation, malabsorption and peritonitis
  • allergy to milk
  • history of previous nutritional supplement from other source within one months
  • chronic kidney disease (eGFR \< 60 ml/min/1.73 m2)
  • Take preoperative supplement less than 14 days
  • Refused or withdraw from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

RECRUITING

Related Publications (17)

  • Komindrg S, Tangsermwong T, Janepanish P. Simplified malnutrition tool for Thai patients. Asia Pac J Clin Nutr. 2013;22(4):516-21. doi: 10.6133/apjcn.2013.22.4.06.

    PMID: 24231010BACKGROUND

  • Antoun S, Rey A, Beal J, Montange F, Pressoir M, Vasson MP, Dupoiron D, Gourdiat-Borye A, Guillaume A, Maget B, Nitenberg G, Raynard B, Bachmann P. Nutritional risk factors in planned oncologic surgery: what clinical and biological parameters should be routinely used? World J Surg. 2009 Aug;33(8):1633-40. doi: 10.1007/s00268-009-0033-3.

    PMID: 19387725BACKGROUND

  • Bozzetti F, Gianotti L, Braga M, Di Carlo V, Mariani L. Postoperative complications in gastrointestinal cancer patients: the joint role of the nutritional status and the nutritional support. Clin Nutr. 2007 Dec;26(6):698-709. doi: 10.1016/j.clnu.2007.06.009. Epub 2007 Aug 1.

    PMID: 17683831RESULT

  • Lohsiriwat V, Lohsiriwat D, Boonnuch W, Chinswangwatanakul V, Akaraviputh T, Lert-Akayamanee N. Pre-operative hypoalbuminemia is a major risk factor for postoperative complications following rectal cancer surgery. World J Gastroenterol. 2008 Feb 28;14(8):1248-51. doi: 10.3748/wjg.14.1248.

    PMID: 18300352RESULT

  • Szczepanik AM, Scislo L, Scully T, Walewska E, Siedlar M, Kolodziejczyk P, Lenart M, Rutkowska M, Galas A, Czupryna A, Kulig J. IL-6 serum levels predict postoperative morbidity in gastric cancer patients. Gastric Cancer. 2011 Aug;14(3):266-73. doi: 10.1007/s10120-011-0039-z. Epub 2011 Apr 20.

    PMID: 21505767RESULT

  • Argiles JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. doi: 10.1016/j.ejon.2005.09.006.

    PMID: 16437757RESULT

  • Garth AK, Newsome CM, Simmance N, Crowe TC. Nutritional status, nutrition practices and post-operative complications in patients with gastrointestinal cancer. J Hum Nutr Diet. 2010 Aug;23(4):393-401. doi: 10.1111/j.1365-277X.2010.01058.x. Epub 2010 Mar 23.

    PMID: 20337847RESULT

  • Kuzu MA, Terzioglu H, Genc V, Erkek AB, Ozban M, Sonyurek P, Elhan AH, Torun N. Preoperative nutritional risk assessment in predicting postoperative outcome in patients undergoing major surgery. World J Surg. 2006 Mar;30(3):378-90. doi: 10.1007/s00268-005-0163-1.

    PMID: 16479353RESULT

  • Baldwin C, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD002008. doi: 10.1002/14651858.CD002008.pub4.

    PMID: 21901680RESULT

  • Burden S, Todd C, Hill J, Lal S. Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008879. doi: 10.1002/14651858.CD008879.pub2.

    PMID: 23152265RESULT

  • Kabata P, Jastrzebski T, Kakol M, Krol K, Bobowicz M, Kosowska A, Jaskiewicz J. Preoperative nutritional support in cancer patients with no clinical signs of malnutrition--prospective randomized controlled trial. Support Care Cancer. 2015 Feb;23(2):365-70. doi: 10.1007/s00520-014-2363-4. Epub 2014 Aug 6.

    PMID: 25091056RESULT

  • Parsons EL, Stratton RJ, Cawood AL, Smith TR, Elia M. Oral nutritional supplements in a randomised trial are more effective than dietary advice at improving quality of life in malnourished care home residents. Clin Nutr. 2017 Feb;36(1):134-142. doi: 10.1016/j.clnu.2016.01.002. Epub 2016 Jan 11.

    PMID: 26847947RESULT

  • Song GM, Tian X, Zhang L, Ou YX, Yi LJ, Shuai T, Zhou JG, Zeng Z, Yang HL. Immunonutrition Support for Patients Undergoing Surgery for Gastrointestinal Malignancy: Preoperative, Postoperative, or Perioperative? A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Jul;94(29):e1225. doi: 10.1097/MD.0000000000001225.

    PMID: 26200648RESULT

  • Burden ST, Gibson DJ, Lal S, Hill J, Pilling M, Soop M, Ramesh A, Todd C. Pre-operative oral nutritional supplementation with dietary advice versus dietary advice alone in weight-losing patients with colorectal cancer: single-blind randomized controlled trial. J Cachexia Sarcopenia Muscle. 2017 Jun;8(3):437-446. doi: 10.1002/jcsm.12170. Epub 2017 Jan 3.

    PMID: 28052576RESULT

  • Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.

    PMID: 12880610RESULT

  • Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

    PMID: 12765673RESULT

  • Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P; DGEM (German Society for Nutritional Medicine); Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Surgery including organ transplantation. Clin Nutr. 2006 Apr;25(2):224-44. doi: 10.1016/j.clnu.2006.01.015. Epub 2006 May 15.

    PMID: 16698152RESULT

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Narongsak Rungsakulkij, MD.

    Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nattapanee Sukphol, MD.

CONTACT

+6622011527nattapanee_benz@hotmail.com

Narongsak Rungsakulkij, MD.

CONTACT

+6622011527narongsak.run@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 20, 2017

Study Start

November 25, 2017

Primary Completion

November 1, 2021

Study Completion

March 1, 2022

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)