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

NCT ID: NCT02537262

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-27
• Study Completion Date: 2017-08-25

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.

Conditions

Colorectal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

carbohydrate group

Group Type: EXPERIMENTAL

carbohydrate beverage

Intervention Type: DIETARY_SUPPLEMENT

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

NPO(None Per Oral) group

Group Type: PLACEBO_COMPARATOR

NPO(None Per Oral)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

carbohydrate beverage

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

Intervention Type: DIETARY_SUPPLEMENT

NPO(None Per Oral)

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 9895071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16919107 (View on PubMed)

Other Identifiers

4-2015-0451

Identifier Type: -

Identifier Source: org_study_id