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Preoperative Loading With Carbohydrates in Lung Cancer Surgery

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ClinicalTrials.gov Identifier: NCT03070626
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Per Reidar Woldbæk, Oslo University Hospital

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).


Condition or disease Intervention/treatment Phase
Lung Neoplasm Dietary Supplement: PreOp® Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Preoperative Loading With Carbohydrates in Lung Cancer Surgery
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Interventional group
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
Dietary Supplement: PreOp®
No preoperative drink.
Other Name: NutriciaPreOp®

No Intervention: Control group
Standard of care: Fasting from 24hours (midnight), night before surgery.



Primary Outcome Measures :
  1. Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day. [ Time Frame: First postoperative day ]
    Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.


Secondary Outcome Measures :
  1. Gastrointestinal discomfort postoperatively. [ Time Frame: First seven postoperative days. ]
    Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.

  2. Heart rhythm disturbances postoperatively. [ Time Frame: First seven postoperative days. ]
    Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.

  3. Time to mobilization. [ Time Frame: First seven postoperative days. ]
    Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.

  4. Length of stay [ Time Frame: First seven postoperative days. ]
    Length of hospital stay to discharge for index admission.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070626


Contacts
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Contact: Per Reidar Woldbæk, MD, PhD +4798895427 UXPEWO@ous-hf.no
Contact: Astrid B. Krohn-Hansen, bachelor +4723015453 ext +4792270669 astkro@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0450
Contact: Per Reidar Woldbaek, MD, PhD    +4798895427    uxpewo@ous-hf.no   
Contact: Astrid Krohn-Hansen, RN    +4792270669    astkro@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital

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Responsible Party: Per Reidar Woldbæk, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03070626     History of Changes
Other Study ID Numbers: 2016/2020
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Reidar Woldbæk, Oslo University Hospital:
General Surgery
Carbohydrates
Perioperative
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases