Preoperative Oral Nutritional Supplement vs Conventional Dietary Advice in Major Gastrointestinal Surgery

Surgery--Complications Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Postoperative Complication Between Preoperative Oral Nutritional Supplement With Dietary Advice and Conventional Dietary Advice Alone in Patients Undergoing Elective Major Gastrointestinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03315195
• Other study ID #: ID 06-60-72
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: March 2022

Study information

• Verified date: February 2020
• Source: Mahidol University
• Contact: Nattapanee Sukphol, MD.
• Phone: +6622011527
• Email: nattapanee_benz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study design is a randomized controlled study. The eligible criteria is all patients who undergoing major gastrointestinal surgery including upper/lower gastrointestinal tract and hepatobiliary and pancratic surgery. After the informed consent are obtained. The patients are randomized into two group (study group and conventional group). The perioperative supplement with oral nutritional support and dietary advice were assigned in the study group. The conventional group were assigned only dietary advice. The blood test and nutritional assessment are performed by investigators in all participants. The participants were assessed two times before the operation (at first assigned and the day before the operation). The duration of nutritional supplement is at least fourteen days.The patient characteristic data, surgical intervention, and postoperative data were collected. The main outcome is the postoperative morbidity and mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: March 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 year

• undergoing major gastrointestinal surgery

• able to take oral diet

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Nutrition Aspect of Cancer
• Surgery--Complications

Intervention

Dietary Supplement:
• Oral nutritional supplement (ONS)
ONS supplement by 500 kcal/day for 14 days

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (17)

Antoun S, Rey A, Béal 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. — View Citation

Argilés JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S39-50. Review. — View Citation

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;(9):CD002008. doi: 10.1002/14651858.CD002008.pub4. — View Citation

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. Epub 2007 Aug 1. — View Citation

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. Review. — View Citation

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 t — View Citation

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 — View Citation

Kabata P, Jastrzebski T, Kakol M, Król 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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kuzu MA, Terzioglu H, Genç V, Erkek AB, Ozban M, Sonyürek 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. — View Citation

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): — View Citation

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: 10.10 — View Citation

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 Randomiz — View Citation

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: 10.10 — View Citation

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 Guid — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Number of complications	30 days after operation