Preoperative Loading With Carbohydrates in Lung Cancer Surgery

NCT ID: NCT03070626

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2020-01-31

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.

Conditions

Lung Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Interventional group

Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.

Group Type: EXPERIMENTAL

PreOp®

Intervention Type: DIETARY_SUPPLEMENT

No preoperative drink.

Control group

Standard of care: Fasting from 24hours (midnight), night before surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PreOp®

No preoperative drink.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NutriciaPreOp®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Per Reidar Woldbæk

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, Oslo County, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Per Reidar Woldbæk, MD, PhD

Role: CONTACT

UXPEWO@ous-hf.no

+4798895427

Astrid B. Krohn-Hansen, bachelor

Role: CONTACT

astkro@ous-hf.no

+4723015453 ext. +4792270669

Facility Contacts

Per Reidar Woldbaek, MD, PhD

Role: primary

uxpewo@ous-hf.no

+4798895427

Astrid Krohn-Hansen, RN

Role: backup

astkro@ous-hf.no

+4792270669

Other Identifiers

2016/2020

Identifier Type: -

Identifier Source: org_study_id