Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Primary Purpose
Lung Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
PreOp®
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Neoplasm focused on measuring General Surgery, Carbohydrates, Perioperative
Eligibility Criteria
Inclusion Criteria:
adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
- ability to understand and speak Norwegian
Exclusion Criteria:
- impaired gastric emptying
- diabetes
- ongoing treatment for pain
- ongoing infection
Sites / Locations
- Oslo University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
Control group
Arm Description
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
Standard of care: Fasting from 24hours (midnight), night before surgery.
Outcomes
Primary Outcome Measures
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
Secondary Outcome Measures
Gastrointestinal discomfort postoperatively.
Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
Heart rhythm disturbances postoperatively.
Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
Time to mobilization.
Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
Length of stay
Length of hospital stay to discharge for index admission.
Full Information
NCT ID
NCT03070626
First Posted
January 20, 2017
Last Updated
March 24, 2017
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03070626
Brief Title
Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Official Title
Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University 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
Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance due to surgical stress.
The aim of this study is to investigate whether preoperative oral carbohydrate loading can contribute to lower incidence of postoperative discomfort and to reduce complications in elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).
Detailed Description
Fasting from 6-12hours before elective surgery is still standard of care in many departements, including our departement in Oslo University Hospital.
Surgery is a trauma that triggers a catabolic stress response with high emissions of hormones and immune activation. These activations can affect brain, heart, muscles and liver. The metabolic changes may in addition influence development of pain, tissue damage, ileus, tachycardia and other hemodynamic disturbances. Preoperative fasting has shown an increase of surgical stress and to impact catabolic processes which secondarily may lead to insulin resistance and hyperglycemia in non-diabetic patients. Insulin resistance and hyperglycaemia are known to increase the incidence of postoperative infections. Previous studies have also shown that prolonged fasting increases the incidence of gastrointestinal problems. A 12 hour fast before surgery has shown delayed recovery.
Studies have shown that patients undergoing lung cancer surgery suffer from multiple symptoms and experience discomfort in the postoperative phase. Symptoms include dyspnea, fatigue, pain, weakness, cough, dry mouth, nervousness, difficulty sleeping, stomach-/intestinal-problems and lack of appetite. Carbohydrate-rich supplements have shown a positive effect on other perioperative symptoms and measures, but is to our knowledge currently not investigated in lung cancer surgery.
Therefore, there is a need to explore the possible advantages of preoperative oral carbohydrate loading in lung cancer surgery.
The primary aim of this study is to investigate whether preoperative carbohydrate loading with PreOp® provides less postoperative discomfort in the early postoperative phase measured by Quality of Recovery-40 (QoR-40), a validated and widely used measure of quality of recovery.
The secondary aim is to investigate if preoperative loading with carbohydrates affect the incidence of postoperative complications such as stomach-/intestinal problems and heart rhythm disorder, in addition to contribute to faster mobilization and to reduce hospital length of stay.
This study may provide important data regarding the lung cancer patients perioperative symptoms, complications and well-being when using a carbohydrate-rich supplement as intervention to standard of care.
In this study, the intervention group will be given 800ml of a oral carbohydrate supplement, PreOp®, the night before surgery and 400ml of the same supplement, PreOp®, 2-4 hours prior to surgery. The control group will be fasted from 24h, the night before surgery, in accordance to the departements standard of care.
Both groups, the interventional and the control group, will follow the department's perioperative course with regard to anesthetic and surgical procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm
Keywords
General Surgery, Carbohydrates, Perioperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care: Fasting from 24hours (midnight), night before surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
PreOp®
Other Intervention Name(s)
NutriciaPreOp®
Intervention Description
No preoperative drink.
Primary Outcome Measure Information:
Title
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
Description
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
Time Frame
First postoperative day
Secondary Outcome Measure Information:
Title
Gastrointestinal discomfort postoperatively.
Description
Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
Time Frame
First seven postoperative days.
Title
Heart rhythm disturbances postoperatively.
Description
Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
Time Frame
First seven postoperative days.
Title
Time to mobilization.
Description
Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
Time Frame
First seven postoperative days.
Title
Length of stay
Description
Length of hospital stay to discharge for index admission.
Time Frame
First seven postoperative days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
ability to understand and speak Norwegian
Exclusion Criteria:
impaired gastric emptying
diabetes
ongoing treatment for pain
ongoing infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Reidar Woldbæk, MD, PhD
Phone
+4798895427
Email
UXPEWO@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid B. Krohn-Hansen, bachelor
Phone
+4723015453
Ext
+4792270669
Email
astkro@ous-hf.no
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Reidar Woldbaek, MD, PhD
Phone
+4798895427
Email
uxpewo@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Astrid Krohn-Hansen, RN
Phone
+4792270669
Email
astkro@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Preoperative Loading With Carbohydrates in Lung Cancer Surgery
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