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Completed

NCT Number: NCT02555020

Effect of Preoperative Oral Carbohydrates on Quality of Recovery

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.

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Key information

Conditions

Evidence of Cholecystectomy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Allocated to Carbohydrated group

Dietary Supplement

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.

Allocated to Placebo group

Dietary Supplement

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

Allocated to MN NPO group,

Dietary Supplement

Patients received NPO from MN.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Acronym: laparoscopy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2015
Registry last updated
Sep 18, 2017

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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