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Completed

NCT Number: NCT00868400

Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

commercially available high-carbohydrate beverage

Dietary Supplement

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

flavored water

Dietary Supplement

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

Primary outcomes

  1. Overall 30-day complication rate

    Time frame: 2 years

Secondary outcomes

  1. Patient discomfort

    Time frame: 2 years

  2. need for insulin infusion

    Time frame: 2 years

  3. Length of intensive care unit and hospital stay

    Time frame: 2 years

  4. Patient recovery

    Time frame: 2 years

  5. Overall 30-day mortality rate

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Collaborators

  • European Society for Surgical Research
  • General Hospital of Nikaia "Saint Panteleimon"
  • Szeged University
  • University Clinical Centre of Kosova
  • University Hospital, Ghent

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2009
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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