STOP smoking and alcohol drinking before OPeration for bladder cancer ﻿(the STOP-OP study),﻿ perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial

Susanne Vahr Lauridsen; Thordis Thomsen; Peter Thind; Hanne Tønnesen

doi:10.1186/s13063-017-2065-6

STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial

Susanne Vahr Lauridsen, Thordis Thomsen, Peter Thind, Hanne Tønnesen

Department of Clinical Medicine

9 Citations (Scopus)

48 Downloads (Pure)

Abstract

BACKGROUND: To evaluate the effect of a smoking-, alcohol- or combined-cessation intervention starting shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy. Secondary objectives are to examine the effect on types and grades of complications, smoking cessation and alcohol cessation, length of hospital stay, health-related quality of life and return to work or habitual level of activity up to 12 months postoperatively.

METHODS/DESIGN: The study is a multi-institutional randomised clinical trial involving 110 patients with a risky alcohol intake and daily smoking who are scheduled for radical cystectomy. Patients will be randomised to the 6-week Gold Standard Programme (GSP) or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. Smoking and alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly meetings and at follow-up.

DISCUSSION: Herein, we report the design of the STOP-OP study, objectives and accrual up-date. This study will provide new knowledge about how to prevent smoking and alcohol-related postoperative complications at the time of bladder cancer surgery. Till now 77 patients have been enrolled. Patient accrual is expected to be finalised before the end of 2017 and data will be published in 2018.

TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02188446 . Registered on 28 May 2014.

Original language	English
Article number	329
Journal	Trials
Volume	18
Number of pages	8
ISSN	1745-6215
DOIs	https://doi.org/10.1186/s13063-017-2065-6
Publication status	Published - 17 Jul 2017

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Lauridsen, S. V., Thomsen, T., Thind, P., & Tønnesen, H. (2017). STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial. Trials, 18, Article 329. https://doi.org/10.1186/s13063-017-2065-6

STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial. / Lauridsen, Susanne Vahr; Thomsen, Thordis; Thind, Peter et al.
In: Trials, Vol. 18, 329, 17.07.2017.

Research output: Contribution to journal › Journal article › Research › peer-review

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abstract = "BACKGROUND: To evaluate the effect of a smoking-, alcohol- or combined-cessation intervention starting shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy. Secondary objectives are to examine the effect on types and grades of complications, smoking cessation and alcohol cessation, length of hospital stay, health-related quality of life and return to work or habitual level of activity up to 12 months postoperatively.METHODS/DESIGN: The study is a multi-institutional randomised clinical trial involving 110 patients with a risky alcohol intake and daily smoking who are scheduled for radical cystectomy. Patients will be randomised to the 6-week Gold Standard Programme (GSP) or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. Smoking and alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly meetings and at follow-up.DISCUSSION: Herein, we report the design of the STOP-OP study, objectives and accrual up-date. This study will provide new knowledge about how to prevent smoking and alcohol-related postoperative complications at the time of bladder cancer surgery. Till now 77 patients have been enrolled. Patient accrual is expected to be finalised before the end of 2017 and data will be published in 2018.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02188446 . Registered on 28 May 2014.",

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AU - Thomsen, Thordis

AU - Thind, Peter

AU - Tønnesen, Hanne

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N2 - BACKGROUND: To evaluate the effect of a smoking-, alcohol- or combined-cessation intervention starting shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy. Secondary objectives are to examine the effect on types and grades of complications, smoking cessation and alcohol cessation, length of hospital stay, health-related quality of life and return to work or habitual level of activity up to 12 months postoperatively.METHODS/DESIGN: The study is a multi-institutional randomised clinical trial involving 110 patients with a risky alcohol intake and daily smoking who are scheduled for radical cystectomy. Patients will be randomised to the 6-week Gold Standard Programme (GSP) or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. Smoking and alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly meetings and at follow-up.DISCUSSION: Herein, we report the design of the STOP-OP study, objectives and accrual up-date. This study will provide new knowledge about how to prevent smoking and alcohol-related postoperative complications at the time of bladder cancer surgery. Till now 77 patients have been enrolled. Patient accrual is expected to be finalised before the end of 2017 and data will be published in 2018.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02188446 . Registered on 28 May 2014.

AB - BACKGROUND: To evaluate the effect of a smoking-, alcohol- or combined-cessation intervention starting shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy. Secondary objectives are to examine the effect on types and grades of complications, smoking cessation and alcohol cessation, length of hospital stay, health-related quality of life and return to work or habitual level of activity up to 12 months postoperatively.METHODS/DESIGN: The study is a multi-institutional randomised clinical trial involving 110 patients with a risky alcohol intake and daily smoking who are scheduled for radical cystectomy. Patients will be randomised to the 6-week Gold Standard Programme (GSP) or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. Smoking and alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly meetings and at follow-up.DISCUSSION: Herein, we report the design of the STOP-OP study, objectives and accrual up-date. This study will provide new knowledge about how to prevent smoking and alcohol-related postoperative complications at the time of bladder cancer surgery. Till now 77 patients have been enrolled. Patient accrual is expected to be finalised before the end of 2017 and data will be published in 2018.TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02188446 . Registered on 28 May 2014.

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