Fast Track Recovery SurgeryNCT03667755
Fast Track Recovery Surgery Among Gynecologic Oncology Patients
A study testing fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding in people with Fast Track Recovery Surgery, run by Universiti Putra Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fast Track Recovery Surgery
- What is being tested?
- fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Oct 2017to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who diagnosed with Gynecologic Cancer stage 1 to stage 4
- candidates for elective operation treatments
- Malaysian aged more than 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Fast Track Recovery Surgery
- Being tested
- fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding
- Keywords
- pre-operation whey protein infused carbohydrate loading, early oral feeding post-operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast track recovery surgery with whey protein infused carbohydrate loading and early oral feedingProcedure or surgery
participants will be carbohydrate loaded with whey protein infused carbohydrate drink and started on early oral feeding post-operation
| Study group | Role | What they receive |
|---|---|---|
| fast track recovery | Experimental | 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. Receives: Procedure: fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding |
| conventional | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
length of post-operative hospital stay
period of hospitalization after operation to discharged
Measured: throughout hospitalization (up to 2 weeks)
length of clear fluid toleration
period of clear fluid toleration post-operation
Measured: throughout hospitalization (up to 1 week)
length of solid food toleration
period of solid food toleration post-operation
Measured: throughout hospitalization (up to 2 weeks)
Secondary outcomes (9)
height
outcomes will be measured once (admission). Measurement in meter.
Measured: throughout hospitalization (up to 2 weeks)
dietary intake trend during hospitalization
kilocalories for energy; gram for protein
Measured: daily energy and protein intake throughout hospitalization (up to 2 weeks)
inflammatory effect
C-reactive protein in mg/L
Measured: 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)
Measured: throughout hospitalization (up to 2 weeks)
re-admission
re-admission within 1 month post operation
Measured: 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
Measured: throughout hospitalization (up to 2 weeks)
weight
outcomes will be measured twice (admission and upon discharged). Units of Measure such as weight in kilogram
Measured: 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
Measured: 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
Measured: throughout hospitalization (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start3 Oct 2017
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fast Track Recovery SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, HO CHIOU YI, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667755
- Sponsor's protocol ID
- NMRR-17-1070-36021
- Status last verified
- Nov 2020
- First submitted
- 25 Aug 2018
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35289396Ho 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.
PubMed 32546217
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03667755
- Acronym / sponsor ID
- NMRR-17-1070-36021
- Conditions
- Fast Track Recovery Surgery
- Keywords
- pre-operation whey protein infused carbohydrate loading, early oral feeding post-operation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast track recovery | Experimental | Procedure: fast track recovery surgery with whey protein infused carbohydrate loading and early oral feedingParticipants 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who diagnosed with Gynecologic Cancer stage 1 to stage 4
- candidates for elective operation treatments
- Malaysian aged more than 18 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast track recovery surgery with whey protein infused carbohydrate loading and early oral feedingparticipants will be carbohydrate loaded with whey protein infused carbohydrate drink and started on early oral feeding post-operation | Procedure or surgery | fast track recovery |
Primary outcome
length of post-operative hospital stay
Time frame: throughout hospitalization (up to 2 weeks)
period of hospitalization after operation to discharged
length of clear fluid toleration
Time frame: throughout hospitalization (up to 1 week)
period of clear fluid toleration post-operation
length of solid food toleration
Time frame: throughout hospitalization (up to 2 weeks)
period of solid food toleration post-operation
9 secondary outcomes
height
Time frame: throughout hospitalization (up to 2 weeks)
dietary intake trend during hospitalization
Time frame: daily energy and protein intake throughout hospitalization (up to 2 weeks)
inflammatory effect
Time frame: on day of operation (before operation and 12 hours after operation)
post-operative complications
Time frame: throughout hospitalization (up to 2 weeks)
re-admission
Time frame: 1 month post-operation
muscle mass
Time frame: throughout hospitalization (up to 2 weeks)
weight
Time frame: throughout hospitalization (up to 2 weeks)
Body Mass Index
Time frame: throughout hospitalization (up to 2 weeks)
handgrip strength
Time frame: throughout hospitalization (up to 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 35289396Chau 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.
- Derived from this study: PubMed 32546217Ho 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.
Related trials for Fast Track Recovery Surgery
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Not yet recruiting
Planned Operating-Room Extubation After Cardiac Surgery
Mechanical Ventilation, Cardiac Surgery
Recruiting
Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass
Valve Disease, Heart, CABG
Active, not recruitingObservational study
Incidence of Chronic Pain in Patients Undergoing Knee Arthroplasty Within a Fast-Track Protocol
Chronic Post Surgical Pain, Functional Recovery
RecruitingObservational study
Early Cognitive Changes After Same-day Discharge Hip and Knee Arthroplasty
Postoperative Cognitive Dysfunction (POCD), Cognitive Change
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding in people with Fast Track Recovery Surgery, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of post-operative hospital stay (time frame: throughout hospitalization (up to 2 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667755, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.