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Effect of a Smoking and Alcohol Cessation Intervention Initiated Shortly Before Radical Cystectomy—the STOP-OP Study : A Randomised Clinical Trial

Lauridsen, Susanne Vahr ; Thomsen, Thordis LU ; Jensen, Jørgen Bjerggaard ; Kallemose, Thomas ; Schmidt Behrend, Monika ; Steffensen, Kirsten ; Poulsen, Alicia Martin ; Jacobsen, André ; Walther, Lisa LU and Isaksson, Anders LU , et al. (2022) In European Urology Focus 8(6). p.1650-1658
Abstract

Background: Evidence concerning the reduction of postoperative complications due to smoking and alcohol drinking in patients undergoing radical cystectomy is incomplete. Objective: To evaluate the efficacy of a 6-wk smoking and/or alcohol cessation intervention, initiated shortly before surgery and continued until 4 wk after, in reducing complications. Design, setting, and participants: Between 2014 and 2018, we enrolled 104 patients with high-risk bladder cancer who were daily smokers or consuming at least 3 units of alcohol daily in a multicentre randomised clinical trial. Intervention: Patients were randomised to a 6-wk intensive smoking and/or alcohol cessation intervention or treatment as usual. Outcome measurements and statistical... (More)

Background: Evidence concerning the reduction of postoperative complications due to smoking and alcohol drinking in patients undergoing radical cystectomy is incomplete. Objective: To evaluate the efficacy of a 6-wk smoking and/or alcohol cessation intervention, initiated shortly before surgery and continued until 4 wk after, in reducing complications. Design, setting, and participants: Between 2014 and 2018, we enrolled 104 patients with high-risk bladder cancer who were daily smokers or consuming at least 3 units of alcohol daily in a multicentre randomised clinical trial. Intervention: Patients were randomised to a 6-wk intensive smoking and/or alcohol cessation intervention or treatment as usual. Outcome measurements and statistical analysis: The primary endpoint was the number of patients developing any postoperative complication, or death, within 30 d after surgery. The secondary endpoints were successful quitters, health-related quality of life, length of stay, time back to habitual activity, and mortality. An intention-to-treat analysis was applied to evaluate treatment effect. Results and limitations: There were some differences in baseline demographic and lifestyle characteristics. Postoperatively, 64% in the intervention group versus 70% in the control group (risk ratio [RR] 0.91, confidence interval [CI] 0.68–1.21, p = 0.51) developed complications. Significantly fewer patients developed three or more complications after 30 d (RR 0.39; CI 0.18–0.84, p = 0.01). The rates of successful quitting were 51% in the intervention group and 27% in the control group (RR 2, CI 1.14–3.51, p = 0.01). The external validity of this trial may be limited because 53% of eligible patients refused participation. Conclusions: Despite a significant effect on the quit rate at completion of the intervention, this multimodal prehabilitation did not show a significant difference regarding our primary outcome postoperative complications. Patient summary: A 6-wk smoking and alcohol cessation intervention in relation to bladder cancer surgery did not reduce postoperative complications, but it was effective in supporting people to quit in the short term.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alcohol drinking, Bladder cancer, Postoperative complications, Radical cystectomy, Smoking, Surgery
in
European Urology Focus
volume
8
issue
6
pages
1650 - 1658
publisher
Elsevier
external identifiers
  • scopus:85125435836
  • pmid:35241394
ISSN
2405-4569
DOI
10.1016/j.euf.2022.02.005
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2022 The Author(s)
id
ed6891c5-c420-481c-aafd-9c0144ffcab8
date added to LUP
2022-04-19 14:00:25
date last changed
2024-06-15 18:35:52
@article{ed6891c5-c420-481c-aafd-9c0144ffcab8,
  abstract     = {{<p>Background: Evidence concerning the reduction of postoperative complications due to smoking and alcohol drinking in patients undergoing radical cystectomy is incomplete. Objective: To evaluate the efficacy of a 6-wk smoking and/or alcohol cessation intervention, initiated shortly before surgery and continued until 4 wk after, in reducing complications. Design, setting, and participants: Between 2014 and 2018, we enrolled 104 patients with high-risk bladder cancer who were daily smokers or consuming at least 3 units of alcohol daily in a multicentre randomised clinical trial. Intervention: Patients were randomised to a 6-wk intensive smoking and/or alcohol cessation intervention or treatment as usual. Outcome measurements and statistical analysis: The primary endpoint was the number of patients developing any postoperative complication, or death, within 30 d after surgery. The secondary endpoints were successful quitters, health-related quality of life, length of stay, time back to habitual activity, and mortality. An intention-to-treat analysis was applied to evaluate treatment effect. Results and limitations: There were some differences in baseline demographic and lifestyle characteristics. Postoperatively, 64% in the intervention group versus 70% in the control group (risk ratio [RR] 0.91, confidence interval [CI] 0.68–1.21, p = 0.51) developed complications. Significantly fewer patients developed three or more complications after 30 d (RR 0.39; CI 0.18–0.84, p = 0.01). The rates of successful quitting were 51% in the intervention group and 27% in the control group (RR 2, CI 1.14–3.51, p = 0.01). The external validity of this trial may be limited because 53% of eligible patients refused participation. Conclusions: Despite a significant effect on the quit rate at completion of the intervention, this multimodal prehabilitation did not show a significant difference regarding our primary outcome postoperative complications. Patient summary: A 6-wk smoking and alcohol cessation intervention in relation to bladder cancer surgery did not reduce postoperative complications, but it was effective in supporting people to quit in the short term.</p>}},
  author       = {{Lauridsen, Susanne Vahr and Thomsen, Thordis and Jensen, Jørgen Bjerggaard and Kallemose, Thomas and Schmidt Behrend, Monika and Steffensen, Kirsten and Poulsen, Alicia Martin and Jacobsen, André and Walther, Lisa and Isaksson, Anders and Thind, Peter and Tønnesen, Hanne}},
  issn         = {{2405-4569}},
  keywords     = {{Alcohol drinking; Bladder cancer; Postoperative complications; Radical cystectomy; Smoking; Surgery}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{1650--1658}},
  publisher    = {{Elsevier}},
  series       = {{European Urology Focus}},
  title        = {{Effect of a Smoking and Alcohol Cessation Intervention Initiated Shortly Before Radical Cystectomy—the STOP-OP Study : A Randomised Clinical Trial}},
  url          = {{http://dx.doi.org/10.1016/j.euf.2022.02.005}},
  doi          = {{10.1016/j.euf.2022.02.005}},
  volume       = {{8}},
  year         = {{2022}},
}