laparoscopy: Effect of Preoperative Oral Carbohydrates on Quality of Recovery

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02555020

Collaborator

(none)

153

Enrollment

Arms

15.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.

Condition or Disease	Intervention/Treatment	Phase
Evidence of Cholecystectomy	Dietary Supplement: Allocated to Carbohydrated group Dietary Supplement: Allocated to Placebo group Dietary Supplement: Allocated to MN NPO group,	Phase 3

Detailed Description

Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Dec 22, 2016

Actual Study Completion Date :

Dec 23, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Allocated to MN NPO group, Patients was administered in hospital Randomization Patient was allocated to MN group Patients were NPO from mid night (MN) to Surgery	Dietary Supplement: Allocated to MN NPO group, Patients received NPO from MN.
Placebo Comparator: Allocated to Placebo group Patients was administered in hospital Randomization Patient was allocated to Placebo group Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.	Dietary Supplement: Allocated to Placebo group Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.
Active Comparator: Allocated to Carbohydrated group Patients was administered in hospital Randomization Patient was allocated to Carbohydrated group Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.	Dietary Supplement: Allocated to Carbohydrated group Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Arm

Intervention/Treatment

Experimental: Allocated to MN NPO group,

Patients was administered in hospital Randomization Patient was allocated to MN group Patients were NPO from mid night (MN) to Surgery

Dietary Supplement: Allocated to MN NPO group,

Patients received NPO from MN.

Placebo Comparator: Allocated to Placebo group

Patients was administered in hospital Randomization Patient was allocated to Placebo group Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.

Dietary Supplement: Allocated to Placebo group

Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.

Active Comparator: Allocated to Carbohydrated group

Patients was administered in hospital Randomization Patient was allocated to Carbohydrated group Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Dietary Supplement: Allocated to Carbohydrated group

Outcome Measures

Primary Outcome Measures

Quality of Recovery score using the QoR-40 Questionnaire [We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days]
We check the QoR-40 Questionnaire at discharge day

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA (I/II)
Laparoscopic cholecystectomy.
KAROFSKY PERFORMANCE SCALE >70,
No history of major operation

Exclusion Criteria:

DM patients
GE reflux Hx patients.
No- compliance,
Previous Abdominal Surgery History

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joon Seong Park, GangNam Severance Hospital, Yonsei University

ClinicalTrials.gov Identifier:

NCT02555020

Other Study ID Numbers:

3-2015-0158

First Posted:

Sep 21, 2015

Last Update Posted:

Sep 18, 2017

Last Verified:

Sep 1, 2017

Study Results

No Results Posted as of Sep 18, 2017