Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery
Recruitment status was Active, not recruiting
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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. |
- Overall 30-day complication rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 |
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| Turkey | |
| Gulhane School of Medicine | |
| Ankara, Turkey, 06018 | |
| 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 May 19, 2013