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A Trial of Preoperative CHO Drinks on Postoperative Walking Capacity in Colorectal Surgery

A Randomized Controlled Trial of Preoperative Carbohydrate Drinks on Postoperative Walking Capacity in Colorectal Surgery.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01844375
Enrollment
70
Registered
2013-05-01
Start date
2013-05-31
Completion date
2016-07-31
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel; Disease, Carbohydrate Absorption, Colorectal Neoplasms, Difficulty Walking

Keywords

oral carbohydrate loading, walking capacity

Brief summary

This prospective randomized controlled study is designed to investigate whether preoperative oral carbohydrate loading improves postoperative walking performance, a surrogate indicator for overall functional recovery, in patients undergoing colorectal surgery as measured by 2-minute and 6-minute walk test. The secondary outcomes are postoperative insulin resistance measured with plasma insulin and glucose concentrations. The tertiary outcomes are duration of hospital stay, patients satisfaction during staying in the hospital and morbidity measured as postoperative complications.

Detailed description

After approval by the Siriraj Institutional Review Board, patients aged greater than 18 years undergoing elective colorectal surgery at Siriraj Hospital will be approached and recruited in this study. Exclusion criteria are diabetes mellitus, any endocrine disorders or metabolic abnormalities, impaired renal function (GFR \<60 ml/min), impaired hepatic function (Child-Pugh score class C), a history of delayed gastric emptying time, body mass index \>30, inability to communicate and severe physical disability. Informed written consent will be obtained from each subject. At the time of admission to the hospital, patients will be randomly allocated to one of the two groups using a computer-generated randomization schedule in a block of five. The carbohydrate (CHO) group will be given the carbohydrate drink (12.5% carbohydrates, 50 kcal/100 ml, 240 mOsmol/l, pH 5.0) while the control group will be given pure water. The pharmacy department is responsible for preparing the carbohydrate drink. The patients in the two groups will be given 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 or pure water. Before induction of anesthesia, a thoracic epidural catheter will be inserted as routine in either the ninth or tenth thoracic intervertebral space in patients undergoing laparotomy colorectal surgery. Lidocaine 2% with epinephrine 1:200,000 3 mL will be injected in the epidural space to produce a bilateral segmental sensory block to ice and pinprick between T6 and T12 dermatomes. The neural blockade was maintained during surgery with additional infusion of bupivacaine 0.25% 4-8 mL/h. General anesthesia will be induced in all patients with same protocol. Preoperative mechanical bowel preparation will be utilized in the case of left-sided colon cancer or rectal cancer. Intravenous prophylactic antibiotics will be administered to every patient. All operations will be performed by well-experienced surgeons. The choice of incision and operation will depend on tumor location and surgeon's discretion. 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. Serum insulin and glucose concentrations will be measured preoperatively, and on the first three postoperative days. Blood sample for insulin will be centrifuged (Cobas® 8000 modular analyzer series; modular pre-analytics evo, Roche) at 3000 rpm for 5 min at 22.5°C and insulin level will be measured by a two-site immunoassay using electrochemiluminescence immunoassay (ECLIA) (Cobas® 8000 modular analyzer series: e 602 module, Roche). Blood sample for glucose will be immediately centrifuged (Kokusan H-28F, Euroscan) at 3500 rpm for 10 min at 25°C and glucose concentration will be measured using an enzymatic (Hexokinase) method (Cobas integra® 800 analyzer; c 702 module, Roche). 24-Hour urine urea nitrogen will be measured on the first three postoperative days. The urine sample will be 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). Postoperative pain at rest and on mobilization at postoperative 24, 48 and 72 hours will be assessed with verbal rating score (VRS) from 0 (no pain) to 10 (worst pain). Postoperative use of analgesics and amount of analgesic medication will be recorded daily during the first three postoperative days. The duration of hospital stay will be measured by time (days) from the day of surgery to the day of discharge. Patient satisfaction during staying in the hospital will be assessed when discharging from the hospital with a verbal rating score

Interventions

DIETARY_SUPPLEMENTCarbohydrate 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.

OTHERControl 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.

Sponsors

Mingkwan Wongyingsinn, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- patients aged greater than 18 years undergoing elective colorectal surgery at Siriraj Hospital

Exclusion criteria

* diabetes mellitus * any endocrine disorders or metabolic abnormalities * impaired renal function (GFR \<60 ml/min) * impaired hepatic function (Child-Pugh score class C) * a history of delayed gastric emptying time * body mass index \>30 * inability to communicate * severe physical disability.

Design outcomes

Primary

MeasureTime frameDescription
Meters Walked During 2-Minute Walk Test72 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.

Secondary

MeasureTime frameDescription
Change of Serum Glucose ConcentrationBaseline and postoperative 24 hoursSerum glucose concentrations will be measured preoperatively, and on the 24 hour postoperatively.
Nitrogen Balanceon 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

Countries

Thailand

Participant flow

Participants by arm

ArmCount
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.
34
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.
34
Total68

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation11

Baseline characteristics

CharacteristicCarbohydrate GroupControl GroupTotal
Age, Continuous62.9 years
STANDARD_DEVIATION 10.2
62.7 years
STANDARD_DEVIATION 9.7
62.8 years
STANDARD_DEVIATION 9.9
Body mass index22.1 kg/m^2
STANDARD_DEVIATION 3.1
23.2 kg/m^2
STANDARD_DEVIATION 3.9
22.6 kg/m^2
STANDARD_DEVIATION 3.5
Sex: Female, Male
Female
17 Participants13 Participants30 Participants
Sex: Female, Male
Male
17 Participants21 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 34
other
Total, other adverse events
0 / 340 / 34
serious
Total, serious adverse events
6 / 344 / 34

Outcome results

Primary

Meters Walked During 2-Minute Walk Test

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.

Time frame: 72 hours after surgery

ArmMeasureValue (MEDIAN)
Carbohydrate GroupMeters Walked During 2-Minute Walk Test70 meters
Control GroupMeters Walked During 2-Minute Walk Test64 meters
p-value: 0.75Kruskal-Wallis
Secondary

Change of Serum Glucose Concentration

Serum glucose concentrations will be measured preoperatively, and on the 24 hour postoperatively.

Time frame: Baseline and postoperative 24 hours

ArmMeasureValue (MEDIAN)
Carbohydrate GroupChange of Serum Glucose Concentration3.2 microunit/mL
Control GroupChange of Serum Glucose Concentration3.8 microunit/mL
Secondary

Nitrogen Balance

24-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

Time frame: on the postoperative day 3

ArmMeasureValue (MEDIAN)
Carbohydrate GroupNitrogen Balance4.7 mg/mL
Control GroupNitrogen Balance3.1 mg/mL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026