Fast Track Recovery Surgery Among Gynecologic Oncology Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667755
• Other study ID #: NMRR-17-1070-36021
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2020
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Candidates will attend Multidisciplinary Clinic (MDC) as appointment date for examination then they will get surgery appointment (admit to ward) 7-14 days after MDC date. Eligible patients will be identified from name list available in the electronic medical record. Selection of patient will be done by assigned research team member then she will approach and inform with study procedures to all potential candidates (selected based on inclusion and exclusion criteria) while they attend MDC during study period. Participants will be randomized into two groups: the carbohydrate-protein (CHO-P) group and conventional (CO) group during admission to hospital via random numbers which are issued by computer program. For the concepts of the CONSORT flow diagram are followed [50]. The Patient Information Consent Form will be given to identify eligible subjects who agreed to be recruited in the study. Subjects are allowed to bring back consent form if she keen to seek advice from family member.

Carbohydrate-protein group: Participants will attend dietitian clinic to have anthropometry & dietary assessment on the same day of admission (before admission). Subjects are 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 (3 hours prior to operation drink) of a lactose-free clear tea-colour fruit flavoured fluid contains 14% whey protein, 86% carbohydrates and 0% lipids. Participants fast for solids for 6 hours from the operation. Participants will be given clear fluid (2 packs Resource peach) within 24 hours post-surgery (without present of bowel sound) and reviewed by dietitian. Staff nurse in-charged will monitor anesthetic risk of drinking whey protein and ensure subject to finish specific drinks prior surgery. When they tolerated at least 500ml of clear fluids, they were given a regular solid diet.

Conventional group: Participants will attend dietitian clinic to have anthropometry & dietary assessment on the same day of admission (before admission). Participants followed conventional operation procedure whereby fasting start 12am until operation. On the first day of post-operation day, participants will be reviewed by gynaecologist and dietitian. They are allowed for clear fluid once there is bowel sound. After tolerated clear fluid, they will proceed for nourishing fluid, then soft diet and they were given a regular solid diet.

On the day of operation and on the first day of post-operative day, blood samples are collected for hemoglobin, renal profile, albumin and C-reactive protein. Biochemical data will be record from electronic medical record. Upon discharge, all participants will be sent to dietitian clinic to assess anthropometry and dietary data.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fast Track Recovery Surgery

Intervention

Procedure:
• fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding
participants will be carbohydrate loaded with whey protein infused carbohydrate drink and started on early oral feeding post-operation

Locations

Country	Name	City	State
Malaysia	National Cancer Institute	Putrajaya	Wilayah Persekutuan Putrajaya

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	National Cancer Institute (NCI)

Country where clinical trial is conducted

Malaysia, 

Outcome

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)