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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01421680
Other study ID # ANSK1101
Secondary ID
Status Completed
Phase N/A
First received August 17, 2011
Last updated March 12, 2014
Start date August 2011
Est. completion date December 2013

Study information

Verified date March 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Dietary Supplement:
Ensure powder
Ensure powder(500kcal) per day for 7 weeks

Locations

Country Name City State
Korea, Republic of Department of Surgery, Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Abbott

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complication rate 7weeks No
Secondary Body weight 7weeks No
Secondary Body composition indices 7weeks No
Secondary Length of hospital stay 7weeks No
Secondary Quality of life 7weeks No
Secondary Postoperative 30-day mortality 7weeks No
Secondary Biochemical assessment of nutritional status 7weeks No
Secondary Readmission rate 7weeks No
Secondary Patient compliance of oral nutritional supplements 7weeks No
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