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.

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Disorders; Colorectal Surgery
• Intervention / Treatment: Dietary supplement: commercially available high-carbohydrate beverage; Dietary supplement: flavored water

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 Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06018
    • Gulhane School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Dietary supplement: flavored water; will be given in doses equal to those of high-carbohydrate beverage
No Intervention: 3; Control
Experimental: 1; High-carbohydrate	Dietary supplement: commercially available high-carbohydrate beverage; 800 ml before the day of surgery, and additional 400 ml two hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall 30-day complication rate	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine
• Collaborators: University Hospital, Ghent; Szeged University; University Clinical Centre of Kosova; General Hospital of Nikaia "Saint Panteleimon"; European Society for Surgical Research
• Investigators: Study Director: Mehmet F Can, Assist Prof, Gulhane School of Medicine, Department of Surgery; Principal Investigator: Avdyl Krasniqi, MD, PhD, University Clinical Centre of Kosova, Department of Surgery; Principal Investigator: Costas Vagianos, Assoc Prof, Agios Panteleimon Regional Hospital, Deparment of Surgery; Principal Investigator: Gokhan Yagci, Assoc Prof, Gulhane School of Medicine, Department of Surgery; Principal Investigator: Gyorgy Lazar, Prof, University of Szeged, Department of Surgery; Principal Investigator: Wim P Ceelen, MD, PhD, Prof, Ghent University Hospital, Department of Surgery

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Preoperative care; colorectal surgery; fasting; carbohydrate
• Other Study ID Numbers: PRECALICS