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

Abstract Introduction: There has been growing evidence on the favourable outcomes of fast tract recovery (FTR) surgery; expedite recovery, minimise complications, reduce length of hospital stay on surgical patients. However, there is lack of evidence on the effectiveness of FTR in surgical gynaecologic cancer patients. Most of previous study did not focus on feeding composition in FTR surgery protocol. This study aims to determine the effectiveness of FTR feeding with whey protein infused carbohydrate loading drink pre-operatively and early oral feeding post-operatively on post-operative outcomes among surgical gynaecologic cancer patients. Methods and analysis: This open labelled RCT will randomly allocate patients into intervention and control group. Ambulated Malaysian aged over 18 years and scheduled for elective surgery for (suspected) GC, will be included in this study. Intervention group will be given whey protein infused carbohydrate loading drinks evening before operation and 3 hours before operation as well as started on early oral feeding 4 hours post-operatively. Control group will be fasted overnight pre-operation and only allowed plain water, and the diet transition fashion is followed when there is bowel sound post-operatively. Primary outcomes of study are length of post-operative hospital stay, length of clear fluid toleration, solid food toleration and bowel function. Additional outcome measures are changes in nutritional status, biochemical profile and functional status. Data will be analysed on an intention-to-treat basis. Trial Registration Number: ClinicalTrials.gov, NCT03667755. Registered 12 September 2018 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03667755Protocol Version: Version 3 dated 27th September 2017