Clinical trial NCT01838109: Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery
Official title: Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Colon Cancer
Pancreatic Cancer
Duodenal Cancer
Biliary Cancer
Peptic Ulcer
Inflammatory Bowel Diseases
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2013-04-23
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight decrease rate 8weeks after discharge compared with preoperative body weight
timeFrame: 8weeks after discharge
Secondary outcomes:
measure: Changes in body weight before and after surgery
timeFrame: preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge
measure: Change of body mass index before and after surgery
timeFrame: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge
measure: changes in PG-SGA score and grade
timeFrame: preoperatively, and 2,4,8 weeks after discharge
measure: serum hemoglobin
timeFrame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
measure: serum total lymphocyte count
timeFrame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
measure: serum total cholesterol
timeFrame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
measure: serum total protein
timeFrame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
measure: serum albumin
timeFrame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Other outcomes:
measure: Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional
timeFrame: pre-operatively, and 2,4,8 weeks after discharge
measure: ONS related gastrointestinal adverse event
timeFrame: upto 8weeks after discharge
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyuk-Joon Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: