NCT03667755

Fast Track Recovery Surgery Among Gynecologic Oncology Patients

Completed NA Last updated 25 November 2020

What this trial tests

NA trial testing fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding in Fast Track Recovery Surgery in 118 participants. Completed in 30 October 2019.

Timeline

3 October 2017

Primary endpoint
30 October 2019

30 October 2019

Quick facts

Lead sponsor	Universiti Putra Malaysia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	118
Start date	3 October 2017
Primary completion	30 October 2019
Estimated completion	30 October 2019
Sites	1 location across Malaysia

Drugs / interventions tested

• fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding

Conditions studied

• Fast Track Recovery Surgery — all drugs for Fast Track Recovery Surgery →

Sponsor

Universiti Putra Malaysia — full company profile →

Who can join

18 and older, female only, with Fast Track Recovery Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial.
   Yi HC, Ibrahim Z, Abu Zaid Z, Mat Daud Z', et al · · 2020 · cited 35× · PMID 31968595 · DOI 10.3390/nu12010264
2. Perioperative enhanced recovery programmes for women with gynaecological cancers.
   Chau JPC, Liu X, Lo SHS, Chien WT, et al · · 2022 · cited 13× · PMID 35289396 · DOI 10.1002/14651858.cd008239.pub5
3. Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial.
   Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud ZA, et al · · 2022 · cited 7× · PMID 35011097 · DOI 10.3390/nu14010222
4. 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.
   Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud Z', et al · · 2020 · cited 7× · PMID 32546217 · DOI 10.1186/s13063-020-04462-4
5. Fast Track Recovery Surgery with A Whey Protein Infused Carbohydrate Loading Drink Pre-Operatively and Early Oral Feeding Post-Operatively among Surgical Gynaecologic Cancer Patients: Study Protocol of an Open Labelled Randomised Controlled Trial
   Ho CY, Ibrahim Z, Yu NBM, Zaid ZA, et al · · 2020 · DOI 10.21203/rs.2.11814/v2