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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02537262
Other study ID # 4-2015-0451
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2015
Est. completion date August 25, 2017

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Preoperative midnight NPO is a traditional method for preventing aspiration during general anesthesia. However, recent studies reported that drinking carbohydrate beverage, three hours prior the surgery helps reducing patients starving, uncomfortment, and fatigue without other complication. QOR 40 is developed for evaluating patients' recovery condition regarding physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS) is a concept for reducing patients' hospital stay and helping recovery. Studies showed that drinking carbohydrate beverage made better recovery of bowel function and shorter hospital stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate drinking through this study.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date August 25, 2017
Est. primary completion date August 25, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

- patients undergoing laparoscopic colorectal surgery,

- 20~85 year-old patients

Exclusion Criteria:

- diabetes mellitus

- Inability to consume clear fluids

- GERD or gastrointestinal obstruction

- Liver cirrhosis

- corticosteroid treatment

- ASA>4

- starting surgery five and more hours after drinking carbohydrate beverage

- pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
carbohydrate beverage
Carbohydrate group drinks carbohydrate beverage 400ml(9PM~MN) the day before the surgery and 200ml three hours before the surgery.
NPO(None Per Oral)
NPO group does not drink any water from the MN before the surgery.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. — View Citation

Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary total score of a survey using Quality of Recovery 40 1 day
Secondary amount of perioperative water intake measure with ml 1 day
Secondary amount of perioperative urine output measure with ml 1 day
Secondary time to bowel function recovery 1 day
Secondary hospital stay duration from operation to discharge 1 month
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