Preoperative Smoking Cessation in Patients Undergoing Surgery

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05192837

Studienbeginn:
April 2022

Letztes Update:
18.08.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Urologic Neoplasms, Postoperative Complications

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Luzerner Kantonsspital

Collaborator:
-

Studienleiter

Christian Fankhauser, PD Dr. med.
Principal Investigator
Klinik für Urologie, Luzerner Kantonsspital

Kontakt

Studienkoordination Tumorzentrum
Kontakt:
Phone: 0041 41 205 59 64
E-Mail: studienkoordination.tumorzentrum@luks.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

LUKS
6000 Luzern
SwitzerlandRekrutierend» Google-Maps

Studien-Informationen

Brief Summary:

Background: At present, effectively implementing smoking cessation programs in the health

care system constitutes a major challenge. A unique opportunity to initiate smoking cessation

focuses on smokers scheduled for surgery. These patients are not only highly motivated to

quit smoking but also likely to benefit from a reduction in postoperative complications which

may translate into a decrease of costs. Nevertheless, surgical patients are not routinely

informed about the benefits of preoperative smoking cessation. Potential reasons for this

missed opportunity may be lack of time and training of surgeons and anesthesiologists. The

investigators therefore aim to analyse the impact of a preoperative high-intensity smoking

cessation intervention on surgical complications up to a 90-day postoperative period in

patients of various surgical disciplines. The hypothesis is that preoperative smoking

cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery.

The primary objective is to compare complications between patients with an institutional

multifaceted smoking cessation intervention starting four weeks before surgery compared to

patients in the advice only group (control group) within a 90-day postoperative period. The

primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery.

Secondary outcomes include length of hospital stay, cost of hospital stay, smoking

abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of

smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking

cessation. The investigators plan to randomize 251 patients. The primary endpoint is the

Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints

include comparison of smoking abstinence, quality of life, mental health, length of stay,

costs of care and difference in hospital reimbursement between the two groups.

Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes

in smokers undergoing surgery.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patient listed for intermediate or high-risk surgery (Appendix 2) [20] at the

Kantonsspital of Lucerne

- Patient undergoing surgery in one of the following departments: Abdominal surgery,

thoracic surgery, urology, gynaecology, vascular surgery or head and neck surgery

- Date of surgery >4 weeks after date of listing for surgery or discussion by tumor

board

- Current smokers, defined as daily smoking of at least one cigarette, cigar or pipe

- Age over 18 years

- Able to give signed written informed consent

Exclusion Criteria:

- Plastic surgery

- Consumption of illegal drugs

- Alcohol dependency defined as preexisting alcohol related disorders (eg. alcoholic

psychosis, Alcohol abuse, Alcohol polyneuropathy, degeneration of nervous system due

to alcohol, Alcoholic myopathy, Alcoholic liver disease)

- Inability to follow the procedures of the study, e.g., due to language problems,

psychological disorders, dementia

Studien-Rationale

Primary outcome:

1. Comprehensive Complication Index (CCI) (Time Frame - within a 90 days postoperative time period):
The primary endpoint is the Comprehensive Complication Index (CCI) within 90 days of surgery. The CCI is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity (multiplication of the median preference values from patients and physicians). The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 to 100 with higher values indicating a higher cumulative burden in a single patient. As a composite complication score, the CCI has the advantage of reflecting the overall burden of the postoperative course that affects the health of patients and their quality of life. In addition, the CCI is a powerful endpoint in trials, as it allows sample size up to nine times lower compared with traditional morbidity endpoints.

Secondary outcome:

1. Length of hospital stay (Time Frame - perioperative):
Days of hospital stay for planned surgery

2. Costs of hospital stay (Time Frame - perioperative):
Costs of hospital stay for planned surgery

3. Readmission rate (Time Frame - within a 90 days postoperative time period):
Readmission rates for in-patient hospital stay after surgery

4. Smoking abstinence (Time Frame - within a one year postoperative time period):
Number of patients who successfully quit smoking

5. Smoking reduction (Time Frame - within a one year postoperative time period):
Decrease or increase of daily nicotine consumption

6. Mental health (Time Frame - one week preoperative):
The outcome is measured using the Hospital anxiety and depression scale (HADS) before surgery. The score ranges from 0 to 42 with higher values indicating a higher probability of a mood disorder.

7. IMC/ICU admission (Time Frame - perioperative):
unplanned postoperative intermediate care or intensive care unit admission

8. Transtheoretical Model (Time Frame - preoperative):
Stage of the Transtheoretical Model of behaviour change

9. Quality of life Short Form Survey (Time Frame - within a one year postoperative time period):
The outcome is measured using the 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100 with higher values indicating a more favorable health state.

Studien-Arme

Experimental: Intervention group
The study intervention consists of a smoking cessation counselling meeting by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery. The goal of this first intervention meeting is to implement an individual treatment plan for preoperative smoking cessation.
No Intervention: Control group
Patients randomised to the control arm will get advice only. Their preoperative course will be as if they were not participating in this study, meaning they will receive inconsistent perioperative smoking cessation advice from nurses, surgeons, or anaesthesiologists but no further study-specific smoking cessation intervention. Importantly, participants in the control group will not be discouraged from using perioperative smoking cessation aids and can still obtain help on one's own initiative.

Geprüfte Regime

Intensive preoperative smoking cessation counselling:
The study intervention consists of an interview by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery with individual counselling and offered nicotine substitution. The intervention meeting is based on the Chronic Care Model (CCM) to improve quality of ambulatory care. In brief, the intervention includes: Informative content about advantages of smoking cessation Scheduling service for a motivational interview by a TSS in office to implement a treatment plan For participants willing to quit smoking a preoperative quit day will be scheduled after the first intervention meeting 2-3 weeks before surgery Patients will be encouraged by a TSS to use nicotine replacement. Bupropion or Vareniclin will be provided on an individual basis TSS will schedule repeated follow-up meetings to support smoking abstinence or nicotine reduction before and after surgery for all patients

Quelle: ClinicalTrials.gov

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