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Study protocol
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
Zuriati Ibrahim
Universiti Putra Malaysia
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6210-0443
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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/NCT03667755
Protocol Version: Version 3 dated 27th September 2017
Keywords
whey protein carbohydrate loading, early oral feeding, surgical gynaecologic cancer
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CURRENT STATUS: Published
Version 2
Posted 14 May, 2020
Published
On 16 Jun, 2020
No community comments so far
Editorial decision: Accept
On 27 May, 2020
Reviewers invited
Invitations sent on 20 May, 2020
Editor assigned
On 06 May, 2020
Submission checks complete
On 19 Jul, 2019
No comments provided
Editorial decision: Major revision
On 26 Apr, 2020
Reviewer #1 agreed
On 23 Jan, 2020
Review #1 received
Received 23 Jan, 2020
Reviewers invited
Invitations sent on 22 Jan, 2020
Editor assigned
On 12 Aug, 2019
Submission checks complete
On 19 Jul, 2019
First submitted
On 28 May, 2019
Metrics
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
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
Zuriati Ibrahim
Universiti Putra Malaysia
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6210-0443
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 14 May, 2020
Published
On 16 Jun, 2020
No community comments so far
Editorial decision: Accept
On 27 May, 2020
Reviewers invited
Invitations sent on 20 May, 2020
Editor assigned
On 06 May, 2020
Submission checks complete
On 19 Jul, 2019
No comments provided
Editorial decision: Major revision
On 26 Apr, 2020
Reviewer #1 agreed
On 23 Jan, 2020
Review #1 received
Received 23 Jan, 2020
Reviewers invited
Invitations sent on 22 Jan, 2020
Editor assigned
On 12 Aug, 2019
Submission checks complete
On 19 Jul, 2019
First submitted
On 28 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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/NCT03667755
Protocol Version: Version 3 dated 27th September 2017