Preoperative Loading With Carbohydrates in Lung Cancer Surgery
1 other identifier
interventional
104
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
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
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMarch 27, 2017
March 1, 2017
2.8 years
January 20, 2017
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
First postoperative day
Secondary Outcomes (4)
Gastrointestinal discomfort postoperatively.
First seven postoperative days.
Heart rhythm disturbances postoperatively.
First seven postoperative days.
Time to mobilization.
First seven postoperative days.
Length of stay
First seven postoperative days.
Study Arms (2)
Interventional group
EXPERIMENTALCarbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
Control group
NO INTERVENTIONStandard of care: Fasting from 24hours (midnight), night before surgery.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients undergoing elective video-assisted thoracoscopic surgery due to lung neoplasms.
- ability to understand and speak Norwegian
You may not qualify if:
- impaired gastric emptying
- diabetes
- ongoing treatment for pain
- ongoing infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Oslo County, 0450, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 20, 2017
First Posted
March 3, 2017
Study Start
March 20, 2017
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
March 27, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share