Preoperative Loading With Carbohydrates in Lung Cancer Surgery

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).

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasm
• Intervention / Treatment: Dietary supplement: PreOp®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • Oslo University Hospital
    • Contact: Per Reidar Woldbaek, MD, PhD; Phone Number: +4798895427; Email: uxpewo@ous-hf.no
    • Contact: Astrid Krohn-Hansen, RN; Phone Number: +4792270669; Email: astkro@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: NutriciaPreOp®
No Intervention: Control group; Standard of care: Fasting from 24hours (midnight), night before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal discomfort postoperatively.	Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.	First seven postoperative days.
Heart rhythm disturbances postoperatively.	Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.	First seven postoperative days.
Time to mobilization.	Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.	First seven postoperative days.
Length of stay	Length of hospital stay to discharge for index admission.	First seven postoperative days.

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: General Surgery; Perioperative; Carbohydrates
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2016/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No