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


N/A
20 Years
N/A
Open (Enrolling)
Both
Malnourished, Stomach Neoplasms, Gastrointestinal Stromal Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Postoperative complication rate

Outcome Time Frame:

7weeks

Safety Issue:

No

Principal Investigator

Han-Kwang Yang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Seoul National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

ANSK1101

NCT ID:

NCT01421680

Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Malnourished
  • Stomach Neoplasms
  • Gastrointestinal Stromal Tumors
  • Neoplasms
  • Stomach Neoplasms
  • Malnutrition
  • Gastrointestinal Stromal Tumors

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