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

NCT01844375 | Completed Results

• 1 other identifier: SIRB050
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

oral carbohydrate loading; walking capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of Serum Glucose Concentration

  Baseline and postoperative 24 hours

• Nitrogen Balance

  on the postoperative day 3

Study Arms (2)

Carbohydrate group

EXPERIMENTAL

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.

Dietary Supplement: Carbohydrate group

Control group

ACTIVE COMPARATOR

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.

Other: Control group

Interventions

Carbohydrate group DIETARY_SUPPLEMENT

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.

Also known as: carbohydrate drink, carbohydrate supplement

Carbohydrate group

Control group OTHER

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.

Also known as: pure water, water

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mingkwan Wongyingsinn, MD: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Disease; Mobility Limitation; Colorectal Neoplasms

Interventions

Control Groups; Water

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr.Mingkwan Wongyingsinn
• Organization: Faculty of Medicine siriraj Hospital

mingkwan.won@mahidol.ac.th

6624197995

Study Officials

• Mingkwan Wongyingsinn, MD, MSc

  Siriraj Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor, Doctor

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 1, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)