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Completed

NCT Number: NCT03757208

Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy

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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Key information

Conditions

Preoperative Care

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbohydrate rich drink

Dietary Supplement

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

Primary outcomes

  1. Number of given pain and antiemetic medication (n)

    Time frame: One day (in recovery room after operation to discharge time)

  2. Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)

    Time frame: One day (4 hours after operation and at discharge)

  3. Time of drinking, eating and first mobilisation (minutes after operation)

    Time frame: One day (in recovery room after operation to discharge time)

  4. Time of discharge (hours after operation)

    Time frame: One day (time of discharge)

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Seinajoki Central Hospital

Registry information

Official study title

Effect of Preoperative Oral Carbohydrate Loading on Recovery in Patients Undergoing Day-case Cholecystectomy. A Randomised Controlled Trial.

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Nov 28, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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