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Effect of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Colorectal Surgery Patients

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ClinicalTrials.gov Identifier: NCT02537262
Recruitment Status : Unknown
Verified March 2016 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : September 1, 2015
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Preoperative midnight NPO is a traditional method for preventing aspiration during general anesthesia. However, recent studies reported that drinking carbohydrate beverage, three hours prior the surgery helps reducing patients starving, uncomfortment, and fatigue without other complication. QOR 40 is developed for evaluating patients' recovery condition regarding physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS) is a concept for reducing patients' hospital stay and helping recovery. Studies showed that drinking carbohydrate beverage made better recovery of bowel function and shorter hospital stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate drinking through this study.

Condition or disease Intervention/treatment Phase
Colorectal Disease Dietary Supplement: carbohydrate beverage Dietary Supplement: NPO(None Per Oral) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Study Start Date : August 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: carbohydrate group Dietary Supplement: carbohydrate beverage
Carbohydrate group drinks carbohydrate beverage 400ml(9PM~MN) the day before the surgery and 200ml three hours before the surgery.

Placebo Comparator: NPO(None Per Oral) group Dietary Supplement: NPO(None Per Oral)
NPO group does not drink any water from the MN before the surgery.




Primary Outcome Measures :
  1. total score of a survey using Quality of Recovery 40 [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. amount of perioperative water intake [ Time Frame: 1 day ]
    measure with ml

  2. amount of perioperative urine output [ Time Frame: 1 day ]
    measure with ml

  3. time to bowel function recovery [ Time Frame: 1 day ]
  4. hospital stay duration from operation to discharge [ Time Frame: 1 month ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing laparoscopic colorectal surgery,
  • 20~85 year-old patients

Exclusion Criteria:

  • diabetes mellitus
  • Inability to consume clear fluids
  • GERD or gastrointestinal obstruction
  • Liver cirrhosis
  • corticosteroid treatment
  • ASA>4
  • starting surgery five and more hours after drinking carbohydrate beverage
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537262


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Ki-Young Lee, MD    82-2-2227-3997    KYLEE504@yuhs.ac   
Sponsors and Collaborators
Yonsei University