Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Gulhane School of Medicine

Status: Completed

Conditions: Colorectal Disorders; Colorectal Surgery

Treatments: Dietary Supplement: commercially available high-carbohydrate beverage; Dietary Supplement: flavored water

Study type: Interventional

Funder types: Other

Identifiers

NCT00868400

PRECALICS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

High-carbohydrate

Treatment:

Dietary Supplement: commercially available high-carbohydrate beverage

2

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: flavored water

3

No Intervention group

Description:

Control