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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 LU ; Thind, Peter and Tønnesen, Hanne LU (2017) In Trials 18(1).
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... (More)

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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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alcohol, Bladder cancer, Postoperative complications, Smoking, Surgery
in
Trials
volume
18
issue
1
publisher
BioMed Central
external identifiers
  • scopus:85024369358
  • wos:000405736400003
ISSN
1745-6215
DOI
10.1186/s13063-017-2065-6
language
English
LU publication?
yes
id
efe56210-b2a7-464b-a687-364769f783f3
date added to LUP
2017-08-02 10:30:25
date last changed
2017-09-18 11:40:48
@article{efe56210-b2a7-464b-a687-364769f783f3,
  abstract     = {<p>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.</p>},
  articleno    = {329},
  author       = {Lauridsen, Susanne Vahr and Thomsen, Thordis and Thind, Peter and Tønnesen, Hanne},
  issn         = {1745-6215},
  keyword      = {Alcohol,Bladder cancer,Postoperative complications,Smoking,Surgery},
  language     = {eng},
  month        = {07},
  number       = {1},
  publisher    = {BioMed Central},
  series       = {Trials},
  title        = {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},
  url          = {http://dx.doi.org/10.1186/s13063-017-2065-6},
  volume       = {18},
  year         = {2017},
}