Non Small Cell Lung CanceroralcarbohydraNCT05005091
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients
A study testing Oral carbohydrate in people with Non Small Cell Lung Cancer and Fasting, run by Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Fasting, Postoperative Pneumonia
- What is being tested?
- Oral carbohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 30 Apr 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-Stage II all operable NSCLC patients -
Who cannot join
- Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
health Science University, Sureyyapa Training and Research Hospital
Istanbul, 34857
About this study
Official title: Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery
Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients.
Read the detailed description
The study was conducted on 94 patients. The patients in the control group were fasting after midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before the operation. 47 patients were in the control group (A) and 47 patients were in the experimental group (B). The groups were compared in terms of length of hospital and intensive care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation parameters, blood glucose, and mobilization time.
SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test were used. In addition, correlation analysis was used to determine the relationship between fasting time and surgical recovery time.
- Conditions
- Non Small Cell Lung Cancer, Fasting, Postoperative Pneumonia
- Being tested
- Oral carbohydrate
- Keywords
- Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral carbohydrateDietary supplement
100 ml oral carbohydrate two hours ago preoperatively
| Study group | Role | What they receive |
|---|---|---|
| oral carbohydrate | Active comparator | the patients drunk oral carbohydrate two hours ago preoperatively Receives: Dietary Supplement: Oral carbohydrate |
| no oral carbohydrate | No intervention | the patients did not drink oral carbohydrate preoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobilization time
postoperative mobilization
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Jan 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansel Atinkaya Baytemir, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005091
- Sponsor's protocol ID
- SureyyapasaM
- Acronym
- oralcarbohydra
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05005091
- Acronym / sponsor ID
- oralcarbohydra / SureyyapasaM
- Conditions
- Non Small Cell Lung Cancer, Fasting, Postoperative Pneumonia
- Keywords
- Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 13 Aug 2021 (actual)
- 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.
Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the patients, but the traditional approach still continues especially in thoracic surgery patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate loading on postoperative morbidity in the patients.
Detailed description
The study was conducted on 94 patients. The patients in the control group were fasting after midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before the operation. 47 patients were in the control group (A) and 47 patients were in the experimental group (B). The groups were compared in terms of length of hospital and intensive care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation parameters, blood glucose, and mobilization time.
SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test were used. In addition, correlation analysis was used to determine the relationship between fasting time and surgical recovery time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral carbohydrate | Active comparator | Dietary Supplement: Oral carbohydratethe patients drunk oral carbohydrate two hours ago preoperatively |
| no oral carbohydrate | No intervention | –the patients did not drink oral carbohydrate preoperatively |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage I-Stage II all operable NSCLC patients -
Key exclusion criteria (2 listed)
- Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery.
- -
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 |
|---|---|---|
| Oral carbohydrate100 ml oral carbohydrate two hours ago preoperatively | Dietary supplement | oral carbohydrate |
Primary outcome
Mobilization time
Time frame: 1 hour
postoperative mobilization
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 13 Aug 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral carbohydrate in people with Non Small Cell Lung Cancer and Fasting, run by Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital 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 2 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 13 Aug 2021. 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. 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?
Mobilization time (time frame: 1 hour). 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 13 Aug 2021.