Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Sponsor

Gulhane School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00868400

Collaborator

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

215

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Disorders Colorectal Surgery	Dietary Supplement: commercially available high-carbohydrate beverage Dietary Supplement: flavored water	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

215 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: 2 Placebo	Dietary Supplement: flavored water will be given in doses equal to those of high-carbohydrate beverage
No Intervention: 3 Control

Arm

Intervention/Treatment

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

Placebo Comparator: 2

Placebo

Dietary Supplement: flavored water

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

No Intervention: 3

Control

Outcome Measures

Primary Outcome Measures

Overall 30-day complication rate [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane School of Medicine	Ankara		Turkey	06018

Sponsors and Collaborators

Gulhane School of Medicine
General Hospital of Nikaia "Saint Panteleimon"
University Clinical Centre of Kosova
University Hospital, Ghent
Szeged University
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