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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
Sponsor:
Information provided by (Responsible Party):
Joon Seong Park, Yonsei University

Brief Summary:
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: Randomized
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

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joon Seong Park, GangNam Severance Hospital, Yonsei University
ClinicalTrials.gov Identifier: NCT02555020    
Other Study ID Numbers: 3-2015-0158
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017