The Effects of Preoperative and Postoperative Oral Nutrit... | NCT01421680

Studies
The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients

NCT01421680

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 14, 2014Estimated

Enrollment

144Actual

Phase

Not Applicable

Conditions

Malnourished
Stomach Neoplasms
Gastrointestinal Stromal Tumors

Interventions

Ensure powder

Countries

South Korea

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 17, 2011

First Submission Date that Met QC Criteria

Aug 19, 2011

First Posted Date

Aug 23, 2011Estimated

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

Mar 12, 2014

Last Update Posted Date

Mar 14, 2014Estimated

Name	Class
Abbott	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.

Detailed Description

Not provided

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

144Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ensure powder	Active Comparator	Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals	Dietary Supplement: Ensure powder
Standard care	No Intervention	Standard care without oral nutritional supplements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ensure powder	Dietary Supplement	Ensure powder(500kcal) per day for 7 weeks	Ensure powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complication rate		7weeks

Secondary Outcomes

Measure	Description	Time Frame
Body weight		7weeks
Body composition indices		7weeks
Length of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 20 years
Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
Patients who can take oral meals
Patients who agree on the informed consent

Exclusion Criteria:

Emergent operation
Patients who received preoperative chemotherapy or radiation therapy within 6 months
Pregnant patients
Patients who cannot consume the Ensure powder
Patients who enrolled another clinical trials

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Han-Kwang Yang, M.D.	Department of Surgery, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Seoul National University Hospital		Seoul		110-744	South Korea

Type	Date	Date Unknown
Release	Apr 3, 2019
Reset	Jun 26, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 3, 2019			Jun 26, 2019

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D013274	Stomach Neoplasms
D046152	Gastrointestinal Stromal Tumors

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided