Fast Track Recovery Surgery Clinical Trial
Official title:
Fast Track Recovery Feeding With a Whey Protein Infused Carbohydrate Loading Drink and Early Oral Feeding Among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labelled Trial
Verified date | November 2020 |
Source | Universiti Putra Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
opened labelled randomised trial. Participants will be randomly divided into control & intervention group during admission to hospital using random numbers. Participants were randomized into two groups: the carbohydrate-protein (CHO-P) group and control (CO) group. Participants were given a specific drink to their group on the evening prior to surgery and three hours before operation. The CHO-P group received 474ml (evening drink) or 237ml (3hours prior to operation drink) of a solution contain 14% whey protein, 86% carbohydrates and 0% lipids and the CO group nil-by-mouth at 12 midnight day of operation. All participants fasted for solids for 6 hours from the operation.
Status | Completed |
Enrollment | 118 |
Est. completion date | October 30, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - who diagnosed with Gynecologic Cancer stage 1 to stage 4 - candidates for elective operation treatments - Malaysian aged more than 18 years old Exclusion Criteria: - Not a candidate for elective operation treatments - Aged <18 years old - Diagnosed with Diabetes Mellitus/Chronic Kidney Disease/Heart disease/Chronic liver disease - Allergy to milk/soy/whey protein - participate other intervention study |
Country | Name | City | State |
---|---|---|---|
Malaysia | National Cancer Institute | Putrajaya | Wilayah Persekutuan Putrajaya |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia | National Cancer Institute (NCI) |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | length of post-operative hospital stay | period of hospitalization after operation to discharged | throughout hospitalization (up to 2 weeks) | |
Primary | length of clear fluid toleration | period of clear fluid toleration post-operation | throughout hospitalization (up to 1 week) | |
Primary | length of solid food toleration | period of solid food toleration post-operation | throughout hospitalization (up to 2 weeks) | |
Secondary | height | outcomes will be measured once (admission). Measurement in meter. | throughout hospitalization (up to 2 weeks) | |
Secondary | dietary intake trend during hospitalization | kilocalories for energy; gram for protein | daily energy and protein intake throughout hospitalization (up to 2 weeks) | |
Secondary | inflammatory effect | C-reactive protein in mg/L | on day of operation (before operation and 12 hours after operation) | |
Secondary | post-operative complications | infection (yes/no), ileus (yes/no), nausea (yes/no), vomiting (yes/no) | throughout hospitalization (up to 2 weeks) | |
Secondary | re-admission | re-admission within 1 month post operation | 1 month post-operation | |
Secondary | muscle mass | Assessment will be measured twice (upon admission and upon discharged). Unit of measure for muscle mass is in kilogram | throughout hospitalization (up to 2 weeks) | |
Secondary | weight | outcomes will be measured twice (admission and upon discharged). Units of Measure such as weight in kilogram | throughout hospitalization (up to 2 weeks) | |
Secondary | Body Mass Index | outcomes will be measured twice (admission and upon discharge). Units of Measure BMI in kg/m^2 | throughout hospitalization (up to 2 weeks) | |
Secondary | handgrip strength | outcomes will be measured twice (admission and upon discharged). Units of Measure is handgrip strength in kilogram | throughout hospitalization (up to 2 weeks) |