NCT02537262

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

August 27, 2015

Last Update Submit

January 14, 2019

Conditions

Colorectal Disease

Keywords

carbohydratequality of recovery(QOR) 40enhanced recovery after surgery(ERAS)

Outcome Measures

Primary Outcomes (1)

  • total score of a survey using Quality of Recovery 40

    1 day

Secondary Outcomes (4)

  • amount of perioperative water intake

    1 day

  • amount of perioperative urine output

    1 day

  • time to bowel function recovery

    1 day

  • hospital stay duration from operation to discharge

    1 month

Study Arms (2)

carbohydrate group

EXPERIMENTAL
Dietary Supplement: carbohydrate beverage

NPO(None Per Oral) group

PLACEBO COMPARATOR
Dietary Supplement: NPO(None Per Oral)

Interventions

carbohydrate beverageDIETARY_SUPPLEMENT

Carbohydrate group drinks carbohydrate beverage 400ml(9PM\~MN) the day before the surgery and 200ml three hours before the surgery.

carbohydrate group
NPO(None Per Oral)DIETARY_SUPPLEMENT

NPO group does not drink any water from the MN before the surgery.

NPO(None Per Oral) group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing laparoscopic colorectal surgery,
  • \~85 year-old patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related 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. doi: 10.1097/00000539-199901000-00016.

    PMID: 9895071BACKGROUND

  • 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. doi: 10.1111/j.1463-1318.2006.00965.x.

    PMID: 16919107BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 1, 2015

Study Start

July 27, 2015

Primary Completion

August 25, 2017

Study Completion

August 25, 2017

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

KR(1)