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

Stomach Neoplasms Clinical Trial

Official title:

A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421680
• Other study ID #: ANSK1101
• 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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• Malnourished
• Malnutrition
• Stomach Neoplasms

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