Effect of Preoperative Oral Carbohydrates on Quality of Recovery (laparoscopy)

September 15, 2017 updated by: Joon Seong Park, Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

153

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. DM patients
  2. GE reflux Hx patients.
  3. No- compliance,
  4. Previous Abdominal Surgery History

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allocated to MN NPO group,
  1. Patients was administered in hospital
  2. Randomization
  3. Patient was allocated to MN group
  4. 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
  1. Patients was administered in hospital
  2. Randomization
  3. Patient was allocated to Placebo group
  4. 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
  1. Patients was administered in hospital
  2. Randomization
  3. Patient was allocated to Carbohydrated group
  4. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery score using the QoR-40 Questionnaire
Time Frame: We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days
We check the QoR-40 Questionnaire at discharge day
We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 22, 2016

Study Completion (Actual)

December 23, 2016

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 3-2015-0158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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