- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03070626
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).
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Oslo, Norge, 0450
- Rekruttering
- Oslo University Hospital
-
Kontakt:
- Per Reidar Woldbaek, MD, PhD
- Telefonnummer: +4798895427
- E-mail: uxpewo@ous-hf.no
-
Kontakt:
- Astrid Krohn-Hansen, RN
- Telefonnummer: +4792270669
- E-mail: astkro@ous-hf.no
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Interventional group
Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.
|
No preoperative drink.
Andre navne:
|
Ingen indgriben: Control group
Standard of care: Fasting from 24hours (midnight), night before surgery.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
Tidsramme: First postoperative day
|
Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.
|
First postoperative day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Gastrointestinal discomfort postoperatively.
Tidsramme: First seven postoperative days.
|
Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.
|
First seven postoperative days.
|
Heart rhythm disturbances postoperatively.
Tidsramme: First seven postoperative days.
|
Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.
|
First seven postoperative days.
|
Time to mobilization.
Tidsramme: First seven postoperative days.
|
Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.
|
First seven postoperative days.
|
Length of stay
Tidsramme: First seven postoperative days.
|
Length of hospital stay to discharge for index admission.
|
First seven postoperative days.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016/2020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lunge-neoplasma
-
Guangzhou First People's HospitalAfsluttet
-
Mansoura UniversityRekrutteringOne Lung VentilationEgypten
-
Chinese Chronic Respiratory Disease Research NetworkRekruttering
-
Dokuz Eylul UniversityAfsluttetOne Lung VentilationKalkun
-
Seoul National University HospitalAfsluttet
-
Seoul National University HospitalAfsluttet
-
Yonsei UniversityAfsluttetOne Lung VentilationKorea, Republikken
-
Sichuan UniversityWest China HospitalMidlertidigt ikke tilgængeligOne Lung Ventilation
-
Joseph D. TobiasAfsluttetOne-lung Ventilation (OLV)Forenede Stater
-
University Health Network, TorontoAktiv, ikke rekrutterende
Kliniske forsøg med PreOp®
-
Insel Gruppe AG, University Hospital BernRekrutteringMikrobiel kolonisering | Kost, sundSchweiz
-
Unity Health TorontoAfsluttetRygsøjlekirurgi | Koronararterie bypass transplantatkirurgiCanada
-
Erasme University HospitalAfsluttet
-
University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)AfsluttetSultDet Forenede Kongerige
-
University College, LondonNutricia, Inc.Afsluttet
-
Baylor Research InstituteAfsluttetBrystkræftForenede Stater
-
University Hospital, GenevaAfsluttetPostoperative komplikationer | Gastrisk bypassSchweiz
-
Medical University of GdanskUkendt
-
Karolinska InstitutetAfsluttetInsulinfølsomhedSverige
-
Helse Stavanger HFAfsluttetInsulin resistens | Østrogenreceptor-positiv brystkræft | Brystkræft i tidligt stadie | Kulhydratopfyldning | Spredning