Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Not Applicable

Completed

• Conditions: Colorectal Surgery; Colorectal Disorders
• Interventions: Dietary Supplement: commercially available high-carbohydrate beverage; Dietary Supplement: flavored water

• Registration Number: NCT00868400
• Lead Sponsor: Gulhane School of Medicine

Brief Summary

The aim of this study is to provide conclusive clinical evidence as to whether or not the preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes of patients undergoing colorectal surgery.

Detailed Description

Preoperative oral carbohydrate loading is an issue that has been investigated extensively in terms of its fundamental and biochemically apparent effects and potential benefits. Most commonly, proponents of the application advocate that it may be beneficial for improving patient outcomes and for decreasing complication rate by attenuating postoperative insulin resistance. To date, however, no study with a sufficient sample size has been able to demonstrate that it has a marked value in clinical practice. Almost all of the clinical benefits ascribed to the application have been based on subjective well-being, which can also be provided with non specific simple beverages. A study conducted to show whether or not the application has direct influence on patient outcome, therefore, could significantly contribute insights on this topic. The present study was planned to consist of three study arms, namely: 1.Study group, which will be given high-carbohydrate beverage (Nutricia preOp®, Numico, Zoetermeer, The Netherlands) 2. Placebo group, which will be given flavored water, and 3. Control group (surgery after overnight fast). The revised power analysis shows that an accrual of 74 patients in each group would allow detecting a 15% difference in the rate of complications with 80% power at the 5% level of significance (two tailed). We hope we will have recruited at least 220 subjects at the end of a two-year course. Once the data recording is complete, this study will be the largest one ever conducted to investigate this topic.

Study Timeline

• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Study Start: 2009-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• patients undergoing colorectal surgery for malignant or benign diseases

Exclusion Criteria

• diabetes
• disorders that prolongs gastric emptying
• existence of an increased risk for aspiration of gastric content
• anal surgery (haemorrhoidectomy, fistulotomy...etc)
• emergency operations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	commercially available high-carbohydrate beverage	High-carbohydrate
2	flavored water	Placebo

Primary Outcome Measures

Name	Time	Method
Overall 30-day complication rate	2 years

Secondary Outcome Measures

Name	Time	Method
Patient discomfort	2 years
Length of intensive care unit and hospital stay	2 years
Overall 30-day mortality rate	2 years
Patient recovery	2 years
need for insulin infusion	2 years

Trial Locations

Locations (1)

Gulhane School of Medicine; 🇹🇷 Ankara, Turkey