Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868400
• Other study ID #: PRECALICS
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: March 9, 2015
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsGreece: Ministry of Health and WelfareHungary: National Institute of PharmacyKosovo: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Disorders
• Colorectal Surgery

Intervention

Dietary Supplement:
• commercially available high-carbohydrate beverage
800 ml before the day of surgery, and additional 400 ml two hours prior to surgery
• flavored water
will be given in doses equal to those of high-carbohydrate beverage

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine	Ankara

Sponsors (6)

Lead Sponsor	Collaborator
Gulhane School of Medicine	European Society for Surgical Research, General Hospital of Nikaia “Saint Panteleimon”, Szeged University, University Clinical Centre of Kosova, University Hospital, Ghent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall 30-day complication rate		2 years	No
Secondary	Patient discomfort		2 years	No
Secondary	need for insulin infusion		2 years	No
Secondary	Length of intensive care unit and hospital stay		2 years	No
Secondary	Patient recovery		2 years	No
Secondary	Overall 30-day mortality rate		2 years	No