Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-08

Study Completion Date

2017-11-15

Brief Summary

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Background: Preoperative carbohydrate loading has been shown to reduce preoperative discomfort and postoperative nausea and vomiting in general surgical patients. Few studies have been focused on patients undergoing day-case surgery.

Objective: The aim of this prospective randomized study was to determine whether preoperative carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.

Design: A randomised controlled trial. Setting: Secondary care in a district general and a university hospital in Finland between 2013-2016.

Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation disorders, BMI \>40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a history of alcohol or drug abuse.

Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery, and the control (Fasting) group fasted from midnight according to standard protocol.

Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first mobilization after surgery, and the time to discharge and hospital readmission were recorded.

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Detailed Description

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Conditions

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Preoperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fasting group

Group Type NO_INTERVENTION

No interventions assigned to this group

Carbohydrate rich drink (CHD) group

Group Type ACTIVE_COMPARATOR

carbohydrate rich drink

Intervention Type DIETARY_SUPPLEMENT

The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,

Interventions

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carbohydrate rich drink

The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients between 18-70 yr (ASA physical status I-II) eligible for day-case cholecystectomy

Exclusion Criteria

* Patients with bleeding or coagulation disorders, BMI \>40, dementia or suffering from insulin-treated diabetes, migraine, Meniere's disease or with history of alcohol or drug abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes