Fast Track Recovery Surgery Among Gynecologic Oncology Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Fast Track Recovery Surgery
• Intervention / Treatment: Procedure: fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Putrajaya
    • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fast track recovery; 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.	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
No Intervention: conventional; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of post-operative hospital stay	period of hospitalization after operation to discharged	throughout hospitalization (up to 2 weeks)
length of clear fluid toleration	period of clear fluid toleration post-operation	throughout hospitalization (up to 1 week)
length of solid food toleration	period of solid food toleration post-operation	throughout hospitalization (up to 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
height	outcomes will be measured once (admission). Measurement in meter.	throughout hospitalization (up to 2 weeks)
dietary intake trend during hospitalization	kilocalories for energy; gram for protein	daily energy and protein intake throughout hospitalization (up to 2 weeks)
inflammatory effect	C-reactive protein in mg/L	on day of operation (before operation and 12 hours after operation)
post-operative complications	infection (yes/no), ileus (yes/no), nausea (yes/no), vomiting (yes/no)	throughout hospitalization (up to 2 weeks)
re-admission	re-admission within 1 month post operation	1 month post-operation
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)
weight	outcomes will be measured twice (admission and upon discharged). Units of Measure such as weight in kilogram	throughout hospitalization (up to 2 weeks)
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)
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)

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
• Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB. Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial. Trials. 2020 Jun 16;21(1):533. doi: 10.1186/s13063-020-04462-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: August 25, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: pre-operation whey protein infused carbohydrate loading; early oral feeding post-operation
• Other Study ID Numbers: NMRR-17-1070-36021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No