Colorectal DisordersNCT00868400
Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery
A study testing commercially available high-carbohydrate beverage and flavored water in people with Colorectal Disorders and Colorectal Surgery, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Colorectal Disorders, Colorectal Surgery
- What is being tested?
- commercially available high-carbohydrate beverage and flavored water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2009to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing colorectal surgery for malignant or benign diseases
Who cannot join
- diabetes
- disorders that prolongs gastric emptying
- existence of an increased risk for aspiration of gastric content
- anal surgery (haemorrhoidectomy, fistulotomy...etc)
- emergency operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre Double-blind Randomized Trial of the Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery.
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.
Read the 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.
- Conditions
- Colorectal Disorders, Colorectal Surgery
- Being tested
- commercially available high-carbohydrate beverage, flavored water
- Keywords
- Preoperative care, colorectal surgery, carbohydrate, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercially available high-carbohydrate beverageDietary supplement
800 ml before the day of surgery, and additional 400 ml two hours prior to surgery
flavored waterDietary supplement
will be given in doses equal to those of high-carbohydrate beverage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High-carbohydrate Receives: Dietary Supplement: commercially available high-carbohydrate beverage |
| 2 | Placebo comparator | Placebo Receives: Dietary Supplement: flavored water |
| 3 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall 30-day complication rate
Measured: 2 years
Secondary outcomes (5)
Patient discomfort
Measured: 2 years
need for insulin infusion
Measured: 2 years
Length of intensive care unit and hospital stay
Measured: 2 years
Patient recovery
Measured: 2 years
Overall 30-day mortality rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Nikaia "Saint Panteleimon", University Clinical Centre of Kosova, University Hospital, Ghent, Szeged University, European Society for Surgical Research
- Responsible party
- Principal investigator, Mehmet Fatih Can, Gulhane School of Medicine
- Investigators
- Mehmet F Can, Assist Prof, Study director, Gulhane School of Medicine, Department of SurgeryAvdyl Krasniqi, MD, PhD, Principal investigator, University Clinical Centre of Kosova, Department of SurgeryCostas Vagianos, Assoc Prof, Principal investigator, Agios Panteleimon Regional Hospital, Deparment of SurgeryGokhan Yagci, Assoc Prof, Principal investigator, Gulhane School of Medicine, Department of SurgeryGyorgy Lazar, Prof, Principal investigator, University of Szeged, Department of SurgeryWim P Ceelen, MD, PhD, Prof, Principal investigator, Ghent University Hospital, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868400
- Sponsor's protocol ID
- PRECALICS
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2009
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Double-blind Randomized Trial of the Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery.
- ClinicalTrials.gov ID
- NCT00868400
- Acronym / sponsor ID
- PRECALICS
- Conditions
- Colorectal Disorders, Colorectal Surgery
- Keywords
- Preoperative care, colorectal surgery, carbohydrate, fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Collaborators
- General Hospital of Nikaia "Saint Panteleimon", University Clinical Centre of Kosova, University Hospital, Ghent, Szeged University, European Society for Surgical Research
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: commercially available high-carbohydrate beverageHigh-carbohydrate |
| 2 | Placebo comparator | Dietary Supplement: flavored waterPlacebo |
| 3 | No intervention | –Control |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing colorectal surgery for malignant or benign diseases
Key exclusion criteria (5 listed)
- diabetes
- disorders that prolongs gastric emptying
- existence of an increased risk for aspiration of gastric content
- anal surgery (haemorrhoidectomy, fistulotomy...etc)
- emergency operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| commercially available high-carbohydrate beverage800 ml before the day of surgery, and additional 400 ml two hours prior to surgery | Dietary supplement | 1 |
| flavored waterwill be given in doses equal to those of high-carbohydrate beverage | Dietary supplement | 2 |
Primary outcome
Overall 30-day complication rate
Time frame: 2 years
5 secondary outcomes
Patient discomfort
Time frame: 2 years
need for insulin infusion
Time frame: 2 years
Length of intensive care unit and hospital stay
Time frame: 2 years
Patient recovery
Time frame: 2 years
Overall 30-day mortality rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet F Can, Assist Prof study director
Gulhane School of Medicine, Department of Surgery
Avdyl Krasniqi, MD, PhD principal investigator
University Clinical Centre of Kosova, Department of Surgery
Costas Vagianos, Assoc Prof principal investigator
Agios Panteleimon Regional Hospital, Deparment of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing commercially available high-carbohydrate beverage and flavored water in people with Colorectal Disorders and Colorectal Surgery, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 30-day complication rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.