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

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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.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-017-2065-6) contains supplementary material, which is available to authorized users.

Related collections

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Author and article information

Contributors

Susanne Vahr Lauridsen: +4535451704 , Susanne.vahr@regionh.dk

Thordis Thomsen: Thordis.thomsen@regionh.dk

Peter Thind: peter.ole.thind@regionh.dk

Hanne Tønnesen: hanne.tonnesen@regionh.dk

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 17 July 2017

Publication date PMC-release: 17 July 2017

Publication date Collection: 2017

Volume: 18

Electronic Location Identifier: 329

Affiliations

[1 ]ISNI 0000 0004 0646 7373, GRID grid.4973.9, Department of Urology, , Copenhagen University Hospital, ; Rigshospitalet, 2112, Blegdamsvej 9, 2100 Copenhagen, Denmark

[2 ]Abdominal Centre, Copenhagen University Hospital, Rigshospitalet and University of Copenhagen, Health and Medical Sciences, Copenhagen, Denmark

[3 ]ISNI 0000 0004 0646 7373, GRID grid.4973.9, Clinical Health Promotion Centre, , Bispebjerg and Frederiksberg Hospital, Copenhagen University Hospitals, ; Copenhagen, Denmark

[4 ]ISNI 0000 0001 0930 2361, GRID grid.4514.4, Clinical Health Promotion Centre, Health Sciences, , Lund University, ; Lund, Sweden

[5 ]ISNI 0000 0001 0728 0170, GRID grid.10825.3e, Health Science, , University of Southern Denmark, ; Odense, Denmark

Article

Publisher ID: 2065

DOI: 10.1186/s13063-017-2065-6

PMC ID: 5513198

PubMed ID: 28716147

SO-VID: 1e6c3279-0cf0-44d8-aa0c-3aac656ff9f6

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 17 January 2017

Date accepted : 26 June 2017

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004191, Novo Nordisk;

Funded by: FundRef http://dx.doi.org/10.13039/501100003035, Aase og Ejnar Danielsens Fond;

Funded by: Flemming Lunds Fond

Funded by: The Danish Bladder Group (DaBlaCa)

Funded by: Medac

Funded by: Löf

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: smoking,alcohol,surgery,postoperative complications,bladder cancer

Data availability:

ScienceOpen disciplines: Medicine

Keywords: smoking, alcohol, surgery, postoperative complications, bladder cancer