Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Gulhane School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Agios Panteleimon Regional Hospital
University Clinical Centre of Kosova
University Hospital, Ghent
Szeged University
European Society for Surgical Research
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT00868400
First received: March 24, 2009
Last updated: March 10, 2011
Last verified: May 2010
  Purpose

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 Intervention
Colorectal Disorders
Colorectal Surgery
Dietary Supplement: commercially available high-carbohydrate beverage
Dietary Supplement: flavored water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Primary Outcome Measures:
  • Overall 30-day complication rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient discomfort [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • need for insulin infusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Length of intensive care unit and hospital stay [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Patient recovery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall 30-day mortality rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 221
Study Start Date: May 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868400

Locations
Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Agios Panteleimon Regional Hospital
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
  More Information

No publications provided

Responsible Party: Mehmet Fatih Can, Gulhane School of Medicine, Department of Surgery
ClinicalTrials.gov Identifier: NCT00868400     History of Changes
Other Study ID Numbers: PRECALICS
Study First Received: March 24, 2009
Last Updated: March 10, 2011
Health Authority: Turkey: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Kosovo: Ministry of Health

Keywords provided by Gulhane School of Medicine:
Preoperative care
colorectal surgery
carbohydrate
fasting

ClinicalTrials.gov processed this record on August 28, 2014