Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838109
• Other study ID #: KSSMN-01
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: May 25, 2015
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Cancer
• Colon Cancer
• Duodenal Cancer
• Duodenal Neoplasms
• Gastric Cancer
• Inflammatory Bowel Diseases
• Pancreatic Cancer
• Pancreatic Neoplasms
• Peptic Ulcer

Intervention

Dietary Supplement:
• oral nutritional supplement

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric measure (Triceps Skinfold Thickness and Mid Arm Muscle Circumference), optional		pre-operatively, and 2,4,8 weeks after discharge	No
Other	ONS related gastrointestinal adverse event		upto 8weeks after discharge	Yes
Primary	Body weight decrease rate 8weeks after discharge compared with preoperative body weight		8weeks after discharge	No
Secondary	Changes in body weight before and after surgery		preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge	No
Secondary	Change of body mass index before and after surgery		preoperatively, at the time of discharge after surgery, and 8 weeks after discharge	No
Secondary	changes in PG-SGA score and grade		preoperatively, and 2,4,8 weeks after discharge	No
Secondary	serum hemoglobin		preoperatively, at the time of discharge, 2,4,8 weeks after discharge	No
Secondary	serum total lymphocyte count		preoperatively, at the time of discharge, 2,4,8 weeks after discharge	No
Secondary	serum total cholesterol		preoperatively, at the time of discharge, 2,4,8 weeks after discharge	No
Secondary	serum total protein		preoperatively, at the time of discharge, 2,4,8 weeks after discharge	No
Secondary	serum albumin		preoperatively, at the time of discharge, 2,4,8 weeks after discharge	No