Effect of Preoperative Oral Carbohydrates on Quality of Recovery (laparoscopy)
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|ClinicalTrials.gov Identifier: NCT02555020|
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
Joon Seong Park, Yonsei University
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||153 participants|
|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 :||September 2015|
|Actual Primary Completion Date :||December 22, 2016|
|Actual Study Completion Date :||December 23, 2016|
Experimental: Allocated to MN NPO group,
Dietary Supplement: Allocated to MN NPO group,
Patients received NPO from MN.
Placebo Comparator: Allocated to Placebo group
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
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.
Primary Outcome Measures :
- 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
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