CClinicalTrials.gg
CompletedNCT02537262Updated Jan 15, 2019

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

An interventional study of carbohydrate beverage and NPO(None Per Oral) in Colorectal Disease, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Colorectal Disease

Keywords

  • carbohydrate
  • quality of recovery(QOR) 40
  • enhanced recovery after surgery(ERAS)
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    carbohydrate group

    Dietary Supplement: carbohydrate beverage

  • Placebo comparator
    NPO(None Per Oral) group

    Dietary Supplement: NPO(None Per Oral)

Interventions

  • Dietary supplementcarbohydrate beverage

    Carbohydrate group drinks carbohydrate beverage 400ml(9PM\~MN) the day before the surgery and 200ml three hours before the surgery.

  • Dietary supplementNPO(None Per Oral)

    NPO group does not drink any water from the MN before the surgery.

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What researchers measure

Primary outcomes

  1. total score of a survey using Quality of Recovery 40

    Time frame: 1 day

Secondary outcomes

  1. amount of perioperative water intake

    measure with ml

    Time frame: 1 day

  2. amount of perioperative urine output

    measure with ml

    Time frame: 1 day

  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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Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
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References and documents

Publications

  • Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016. PubMed 9895071 ↗
  • Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x. PubMed 16919107 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02537262
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 1, 2015
Start date
Jul 27, 2015
Primary completion
Aug 25, 2017
Completion
Aug 25, 2017
Last update
Jan 15, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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