Preoperative Oral Nutritional Supplement vs Conventional... | NCT03315195

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

NCT03315195

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Feb 20, 2020Actual

Enrollment

268Estimated

Phase

Not Applicable

Conditions

Surgery--Complications
Nutrition Aspect of Cancer

Interventions

Oral nutritional supplement (ONS)

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2017Actual

Primary Completion Date

Nov 2021Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Oct 5, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2020

Last Update Posted Date

Feb 20, 2020Actual

Name	Class
Ramathibodi Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

268Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oral nutritional supplement (ONS)	Dietary Supplement	ONS supplement by 500 kcal/day for 14 days	Preoperative oral nutritional supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications	Number of complications	30 days after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nattapanee Sukphol, MD.	Contact	+6622011527	245	nattapanee_benz@hotmail.com
Narongsak Rungsakulkij, MD.	Contact	+6622011527	245	narongsak.run@mahidol.ac.th

Overall Officials

Name	Affiliation	Role
Narongsak Rungsakulkij, MD.	Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ramathibodi Hospital	Recruiting	Bangkok		10400	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24231010	Background	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.
19387725	Background	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.

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages