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NCT Number: NCT01838109

Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.

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Key information

Conditions

Gastric Cancer Biliary Cancer Biliary Tract Diseases Biliary Tract Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Duodenal Cancer Duodenal Diseases Duodenal Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Peptic Ulcer Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female who are 20 or more years old and not more than 80 years old
  • Discharge from a hospital is planned within 2 weeks after major gastrointestinal surgery (except when ileostomy is performed)
  • oral intake is possible at the time of discharge
  • no preoperative chemotherapy or preoperative radiotherapy
  • voluntarily agreed with the informed consent of this clinical trial

Exclusion criteria

  • Intravenous or other specific nutritional treatment is needed
  • BMI >25 and postoperative weight loss is not > 5% of preoperative body weight at the time of discharge
  • Allergy to milk, whey, bean, salmon, or the investigational product
  • Residual of cancer in the abdominal cavity postoperatively if it is cancer case
  • Presence of synchronous other cancers that needs treatment.
  • When investigator judged that the patient is not eligible to the trial

Treatment and study plan

Oral Nutritional Supplement

Dietary Supplement

Other names: Encover

Primary outcomes

  1. Body weight decrease rate 8weeks after discharge compared with preoperative body weight

    Time frame: 8weeks after discharge

Secondary outcomes

  1. Changes in body weight before and after surgery

    Time frame: preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge

  2. Change of body mass index before and after surgery

    Time frame: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge

  3. changes in PG-SGA score and grade

    Time frame: preoperatively, and 2,4,8 weeks after discharge

  4. serum hemoglobin

    Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge

  5. serum total lymphocyte count

    Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge

  6. serum total cholesterol

    Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge

  7. serum total protein

    Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge

  8. serum albumin

    Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge

Other outcomes

  1. Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional

    Time frame: pre-operatively, and 2,4,8 weeks after discharge

  2. ONS related gastrointestinal adverse event

    Time frame: upto 8weeks after discharge

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • JW Pharmaceutical

Registry information

Official study title

Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2013
Registry last updated
May 27, 2015

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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