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.
1 other identifier
interventional
215
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 10, 2015
March 1, 2015
3 years
March 24, 2009
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall 30-day complication rate
2 years
Secondary Outcomes (5)
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
Study Arms (3)
1
EXPERIMENTALHigh-carbohydrate
2
PLACEBO COMPARATORPlacebo
3
NO INTERVENTIONControl
Interventions
800 ml before the day of surgery, and additional 400 ml two hours prior to surgery
will be given in doses equal to those of high-carbohydrate beverage
Eligibility Criteria
You may qualify if:
- patients undergoing colorectal surgery for malignant or benign diseases
You may not qualify if:
- diabetes
- disorders that prolongs gastric emptying
- existence of an increased risk for aspiration of gastric content
- anal surgery (haemorrhoidectomy, fistulotomy...etc)
- emergency operations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gulhane School of Medicinelead
- General Hospital of Nikaia "Saint Panteleimon"collaborator
- University Clinical Centre of Kosovacollaborator
- University Hospital, Ghentcollaborator
- Szeged Universitycollaborator
- European Society for Surgical Researchcollaborator
Study Sites (1)
Gulhane School of Medicine
Ankara, 06018, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 24, 2009
First Posted
March 25, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 10, 2015
Record last verified: 2015-03