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Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Multi-centre Double-blind Randomized Trial of the Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00868400
Enrollment
215
Registered
2009-03-25
Start date
2009-05-31
Completion date
2012-05-31
Last updated
2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders, Colorectal Surgery

Keywords

Preoperative care, colorectal surgery, carbohydrate, fasting

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.

Interventions

DIETARY_SUPPLEMENTcommercially available high-carbohydrate beverage

800 ml before the day of surgery, and additional 400 ml two hours prior to surgery

DIETARY_SUPPLEMENTflavored water

will be given in doses equal to those of high-carbohydrate beverage

Sponsors

General Hospital of Nikaia Saint Panteleimon
CollaboratorOTHER
University Clinical Centre of Kosova
CollaboratorOTHER
University Hospital, Ghent
CollaboratorOTHER
Szeged University
CollaboratorOTHER
European Society for Surgical Research
CollaboratorOTHER
Gulhane School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall 30-day complication rate2 years

Secondary

MeasureTime frame
Patient discomfort2 years
need for insulin infusion2 years
Length of intensive care unit and hospital stay2 years
Patient recovery2 years
Overall 30-day mortality rate2 years

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026