Effect of Preoperative Oral Carbohydrates on Quality of R... | NCT02537262

Studies
Effect of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Colorectal Surgery Patients

NCT02537262

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 15, 2019Actual

Enrollment

74Actual

Phase

Not Applicable

Conditions

Colorectal Disease

Interventions

carbohydrate beverage
NPO(None Per Oral)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2015Actual

Primary Completion Date

Aug 25, 2017Actual

Completion Date

Aug 25, 2017Actual

First Submitted Date

Aug 27, 2015

First Submission Date that Met QC Criteria

Aug 27, 2015

First Posted Date

Sep 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2019

Last Update Posted Date

Jan 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
carbohydrate group	Experimental		Dietary Supplement: carbohydrate beverage
NPO(None Per Oral) group	Placebo Comparator		Dietary Supplement: NPO(None Per Oral)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carbohydrate beverage	Dietary Supplement	Carbohydrate group drinks carbohydrate beverage 400ml(9PM~MN) the day before the surgery and 200ml three hours before the surgery.	carbohydrate group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total score of a survey using Quality of Recovery 40		1 day

Secondary Outcomes

Measure	Description	Time Frame
amount of perioperative water intake	measure with ml	1 day
amount of perioperative urine output	measure with ml	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine		Seoul		120-752	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9895071	Background	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.
16919107	Background