Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients (oralcarbohydra)
Primary Purpose
Non Small Cell Lung Cancer, Fasting, Postoperative Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oral carbohydrate
Sponsored by
About this trial
This is an interventional prevention trial for Non Small Cell Lung Cancer focused on measuring Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery
Eligibility Criteria
Inclusion Criteria:
Stage I-Stage II all operable NSCLC patients -
Exclusion Criteria:
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.
-
Sites / Locations
- health Science University, Sureyyapa Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
oral carbohydrate
no oral carbohydrate
Arm Description
the patients drunk oral carbohydrate two hours ago preoperatively
the patients did not drink oral carbohydrate preoperatively
Outcomes
Primary Outcome Measures
Mobilization time
postoperative mobilization
Secondary Outcome Measures
Full Information
NCT ID
NCT05005091
First Posted
August 8, 2021
Last Updated
August 12, 2021
Sponsor
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05005091
Brief Title
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients
Acronym
oralcarbohydra
Official Title
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Fasting, Postoperative Pneumonia
Keywords
Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral carbohydrate
Arm Type
Active Comparator
Arm Description
the patients drunk oral carbohydrate two hours ago preoperatively
Arm Title
no oral carbohydrate
Arm Type
No Intervention
Arm Description
the patients did not drink oral carbohydrate preoperatively
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral carbohydrate
Intervention Description
100 ml oral carbohydrate two hours ago preoperatively
Primary Outcome Measure Information:
Title
Mobilization time
Description
postoperative mobilization
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I-Stage II all operable NSCLC patients -
Exclusion Criteria:
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.
-
Facility Information:
Facility Name
health Science University, Sureyyapa Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34857
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients
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