Trial Outcomes & Findings for A Trial of Preoperative CHO Drinks on Postoperative Walking Capacity in Colorectal Surgery (NCT NCT01844375)
NCT ID: NCT01844375
Last Updated: 2019-11-04
Results Overview
Primary outcomes are 2-minute walk test (2MWT) which will be measured before surgery to be a baseline, and then 2MWT will be measured at 72 hours after surgery. Patients will be asked to walk back and forth along a 15 m stretch of hallway as much as they can over a period of 2 minutes. To ensure safety, the evaluator walks behind the patient. Patients are told that they can rest if necessary, and they are allowed to use their regular walking aids. Any intravenous lines, tubes, or infusion pumps will be attached to a pole and pushed by the patient. The walking distance will be recorded in meters. If the patient is unwilling or unable to walk, the reason will be recorded and the distance '0' will be recorded for that day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
72 hours after surgery
Results posted on
2019-11-04
Participant Flow
Participant milestones
| Measure |
Carbohydrate Group
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
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|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Carbohydrate Group
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
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|---|---|---|
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Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
A Trial of Preoperative CHO Drinks on Postoperative Walking Capacity in Colorectal Surgery
Baseline characteristics by cohort
| Measure |
Carbohydrate Group
n=34 Participants
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
n=34 Participants
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Body mass index
|
22.1 kg/m^2
STANDARD_DEVIATION 3.1 • n=5 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hours after surgeryPrimary outcomes are 2-minute walk test (2MWT) which will be measured before surgery to be a baseline, and then 2MWT will be measured at 72 hours after surgery. Patients will be asked to walk back and forth along a 15 m stretch of hallway as much as they can over a period of 2 minutes. To ensure safety, the evaluator walks behind the patient. Patients are told that they can rest if necessary, and they are allowed to use their regular walking aids. Any intravenous lines, tubes, or infusion pumps will be attached to a pole and pushed by the patient. The walking distance will be recorded in meters. If the patient is unwilling or unable to walk, the reason will be recorded and the distance '0' will be recorded for that day.
Outcome measures
| Measure |
Carbohydrate Group
n=34 Participants
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
n=34 Participants
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
|---|---|---|
|
Meters Walked During 2-Minute Walk Test
|
70 meters
Interval 48.0 to 102.0
|
64 meters
Interval 55.0 to 94.0
|
SECONDARY outcome
Timeframe: Baseline and postoperative 24 hoursSerum glucose concentrations will be measured preoperatively, and on the 24 hour postoperatively.
Outcome measures
| Measure |
Carbohydrate Group
n=34 Participants
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
n=34 Participants
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
|---|---|---|
|
Change of Serum Glucose Concentration
|
3.2 microunit/mL
Interval -7.1 to 11.9
|
3.8 microunit/mL
Interval -3.5 to 8.2
|
SECONDARY outcome
Timeframe: on the postoperative day 324-hour urine urea nitrogen was measured on the postoperative day 3. The urine samples during 24 hours on the postoperative day 3 were centrifuged (Cobas 8000 Modular Analyzer Series; Modular Pre-analytics Evo, Roche) at 3000 rpm for 5 min at 22.5°C, and measured using a urease/glutamate dehydrogenase coupled enzymatic technique (Cobas 8000 Modular Analyzer Series: C 702 Module, Roche). The nitrogen balance was calculated by measuring urinary urea nitrogen and dietary nitrogen intake during the same 24-hour period. The nitrogen intake was estimated for each patient following a doctor's diet order and types of food formulas in hospital, and then dividing the daily protein intake by 6.25. The urine urea nitrogen was added by 4 to account for non-urinary losses of nitrogen
Outcome measures
| Measure |
Carbohydrate Group
n=34 Participants
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
n=34 Participants
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
|---|---|---|
|
Nitrogen Balance
|
4.7 mg/mL
Interval 2.9 to 6.3
|
3.1 mg/mL
Interval -4.8 to 5.3
|
Adverse Events
Carbohydrate Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carbohydrate Group
n=34 participants at risk
The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except the carbohydrate drink. The pharmacy department is responsible for preparing the carbohydrate drink.
Carbohydrate group: The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
Control Group
n=34 participants at risk
The control group will be given pure water 800 mL of one of the drinks the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning of the operation day. The last drink will be no later than 3 hours before the scheduled induction of anesthesia. Of note, the last meal on the day before the operation will be no later than 1800 h. Following this meal, no food or drink will be allowed except pure water.
Control group: The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
|
|---|---|---|
|
Infections and infestations
Infected surgical wound
|
5.9%
2/34 • Number of events 2 • 30 days
|
5.9%
2/34 • Number of events 2 • 30 days
|
|
Gastrointestinal disorders
Bowel ileus
|
5.9%
2/34 • Number of events 2 • 30 days
|
2.9%
1/34 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Anastomosis leakage
|
2.9%
1/34 • Number of events 1 • 30 days
|
2.9%
1/34 • Number of events 1 • 30 days
|
|
Immune system disorders
Fever
|
2.9%
1/34 • Number of events 1 • 30 days
|
0.00%
0/34 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr.Mingkwan Wongyingsinn
Faculty of Medicine siriraj Hospital
Phone: 6624197995
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place