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Completed

NCT Number: NCT01421680

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

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.

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Key information

Conditions

Malnourished Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Malnutrition Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Nutrition Disorders Nutritional and Metabolic Diseases Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ensure powder

Dietary Supplement

Ensure powder(500kcal) per day for 7 weeks

Other names: Ensure powder (Abbott)

Primary outcomes

  1. Postoperative complication rate

    Time frame: 7weeks

Secondary outcomes

  1. Body weight

    Time frame: 7weeks

  2. Body composition indices

    Time frame: 7weeks

  3. Length of hospital stay

    Time frame: 7weeks

  4. Quality of life

    Time frame: 7weeks

  5. Postoperative 30-day mortality

    Time frame: 7weeks

  6. Biochemical assessment of nutritional status

    Time frame: 7weeks

  7. Readmission rate

    Time frame: 7weeks

  8. Patient compliance of oral nutritional supplements

    Time frame: 7weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2011
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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