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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844375
• Other study ID #: SIRB050
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: July 2016

Study information

• Verified date: October 2019
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bowel; Disease, Carbohydrate Absorption
• Colorectal Neoplasms
• Difficulty Walking
• Mobility Limitation

Intervention

Dietary Supplement:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mingkwan Wongyingsinn, MD

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	72 hours after surgery
Secondary	Change of Serum Glucose Concentration	Serum glucose concentrations will be measured preoperatively, and on the 24 hour postoperatively.	Baseline and postoperative 24 hours
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	on the postoperative day 3