Clinical trial NCT00868400: Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery
Official title: Multi-centre Double-blind Randomized Trial of the Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Disorders
Colorectal Surgery
Keywords: Preoperative care
colorectal surgery
carbohydrate
fasting
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
Collaborators: name: General Hospital of Nikaia "Saint Panteleimon"
name: University Clinical Centre of Kosova
name: University Hospital, Ghent
name: Szeged University
name: European Society for Surgical Research
First posted: 2009-03-25
Enrollment: 215
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Overall 30-day complication rate
timeFrame: 2 years
Secondary outcomes:
measure: Patient discomfort
timeFrame: 2 years
measure: need for insulin infusion
timeFrame: 2 years
measure: Length of intensive care unit and hospital stay
timeFrame: 2 years
measure: Patient recovery
timeFrame: 2 years
measure: Overall 30-day mortality rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
affiliation: Gulhane School of Medicine, Department of Surgery
name: Mehmet F Can, Assist Prof
role: STUDY_DIRECTOR
affiliation: University Clinical Centre of Kosova, Department of Surgery
name: Avdyl Krasniqi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Agios Panteleimon Regional Hospital, Deparment of Surgery
name: Costas Vagianos, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gulhane School of Medicine, Department of Surgery
name: Gokhan Yagci, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Szeged, Department of Surgery
name: Gyorgy Lazar, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghent University Hospital, Department of Surgery
name: Wim P Ceelen, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References: