NCT01421680

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

August 17, 2011

Last Update Submit

March 12, 2014

Conditions

MalnourishedStomach NeoplasmsGastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication rate

    7weeks

Secondary Outcomes (8)

  • Body weight

    7weeks

  • Body composition indices

    7weeks

  • Length of hospital stay

    7weeks

  • Quality of life

    7weeks

  • Postoperative 30-day mortality

    7weeks

  • +3 more secondary outcomes

Study Arms (2)

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

Ensure powderDIETARY_SUPPLEMENT

Ensure powder(500kcal) per day for 7 weeks

Also known as: Ensure powder (Abbott)
Ensure powder

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

MalnutritionStomach NeoplasmsGastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Han-Kwang Yang, M.D.

    Department of Surgery, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 23, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

KR(1)