A Randomized Controlled Trial of Preoperative Carbohydrate Drinks on Postoperative Walking Capacity in Colorectal Surgery.
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 and 6-minute walk test (2MWT and 6MWT) which will be
measured before surgery to be a baseline, and then 2MWT will be measured at 24, 48 and 72
hours after surgery; and 6MWT will be measured when patients come back to follow up with
surgeons after the operation 7-10 days. 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 and 6 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,
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
The walking capacity
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 24, 48 and 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.
at postoperative 24, 48 and 72 hour
Mingkwan Wongyingsinn, MD, MSc
Thailand: Ethical Committee