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Surgery--ComplicationsNCT03315195

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

A study testing Oral nutritional supplement (ONS) in people with Surgery--Complications and Nutrition Aspect of Cancer, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oral nutritional supplement (ONS)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteThailand
Study dates
25 Nov 2017to Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Nattapanee Sukphol, MD. contact

+6622011527 ext. 245

nattapanee_benz@hotmail.com

Narongsak Rungsakulkij, MD. contact

+6622011527 ext. 245

narongsak.run@mahidol.ac.th

Thailand1 site, 1 recruiting

  • Ramathibodi Hospital

    Bangkok, 10400

    Nattapanee Sukphol, M.D., +6622011527 ext. 245, nattapanee_benz@hotmail.com

    Recruiting

Other trials in Thailand

About this study

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

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.

Read the detailed 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.

Being tested
Oral nutritional supplement (ONS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral nutritional supplement (ONS)Dietary supplement

    Also called Nutren

    ONS supplement by 500 kcal/day for 14 days

Study groups in NCT03315195
Study groupRoleWhat they receive
Preoperative oral nutritional supplementExperimentalOral nutritional supplement 500 kcal/day for 14 days and dietary advice
Receives: Dietary Supplement: Oral nutritional supplement (ONS)
Conventional treatmentNo interventionDietary advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative complications

    Number of complications

    Measured: 30 days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2017
  2. Study start25 Nov 2017
  3. Primary completionNov 2021 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03315195
Sponsor's protocol ID
ID 06-60-72
Status last verified
Feb 2020
First submitted
5 Oct 2017
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24231010

  • 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.

    PubMed 19387725

  • 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.

    PubMed 17683831

  • 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.

    PubMed 18300352

  • 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.

    PubMed 21505767

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

    PubMed 16437757

  • 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.

    PubMed 20337847

  • 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.

    PubMed 16479353

  • 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.

    PubMed 21901680

  • 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.

    PubMed 23152265

  • 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.

    PubMed 25091056

  • 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.

    PubMed 26847947

  • 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.

    PubMed 26200648

  • 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.

    PubMed 28052576

  • 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.

    PubMed 12880610

Questions about this trial

What is this clinical trial studying?

A study testing Oral nutritional supplement (ONS) in people with Surgery--Complications and Nutrition Aspect of Cancer, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nattapanee Sukphol, MD. (+6622011527 ext. 245, nattapanee_benz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative complications (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315195, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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