LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer

Thordis Thorsteinsdottir; Johan Stranne; Stefan Carlsson; Bo Anderberg; Ingela Björholt; Jan Erik Damber; Jonas Hugosson; Ulrica Wilderång; Peter Wiklund; Gunnar Steineck; Eva Haglind

doi:10.3109/00365599.2010.532506

LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer

Thordis Thorsteinsdottir^*, Johan Stranne, Stefan Carlsson, Bo Anderberg, Ingela Björholt, Jan Erik Damber, Jonas Hugosson, Ulrica Wilderång, Peter Wiklund, Gunnar Steineck, Eva Haglind

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

56 Citations (Scopus)

Abstract

Objective: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. Material and methods. The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. Results. The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. Conclusions. The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.

Original language	English
Pages (from-to)	102-112
Number of pages	11
Journal	Scandinavian Journal of Urology and Nephrology
Volume	45
Issue number	2
DOIs	https://doi.org/10.3109/00365599.2010.532506
Publication status	Published - Mar 2011

Bibliographical note

Funding Information:
The authors are grateful to the members of the LAP-PRO steering committee and local investigators at the participating urology departments: Anders Bjartell, Malmö University Hospital; Ola Bratt, Helsingborg Hospital; Hans Boman, Alingsås Hospital; Christer Edlund, Kungsbacka Hospital; Sven Grundtman, Uddevalla Hospital; Ove Gustafsson, Karolinska University Hospital/Huddinge; Thomas Jiborn, Malmö University Hospital; Ingrid Höglund Karlsson, Sahlgrenska University Hospital; Ali Khatami, Sahlgrenska University Hospital; Mikael Lagerkvist, UroClinic Stockholm; Eric Pileblad, Capio Lundby Hospital; Mikael Sylme, Varberg Hospital; and Ulrika Westlund, Södersjukhuset. The authors are also grateful to the personnel at the LAPPRO trial secretariat and the regional tumour registry and oncologic centre, Sahlgrenska University Hospital, for their essential input into the study procedure. Torgny Anderson at Interezza developed and supported technically the management of the patient-contact database. The trial is supported by grants from the Swedish Cancer Foundation, the West Gothia Region, Sahlgrenska University Hospital, Sanofi-Aventis and Mary von Sydow Foundation.

Other keywords

Clinical trial
prostate neoplasm
retropubic radical prostatectomy
robot-assisted laparoscopic radical prostatectomy
study design
urological surgical procedures

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10.3109/00365599.2010.532506

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Thorsteinsdottir, T., Stranne, J., Carlsson, S., Anderberg, B., Björholt, I., Damber, J. E., Hugosson, J., Wilderång, U., Wiklund, P., Steineck, G., & Haglind, E. (2011). LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer. Scandinavian Journal of Urology and Nephrology, 45(2), 102-112. https://doi.org/10.3109/00365599.2010.532506

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title = "LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer",

abstract = "Objective: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. Material and methods. The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. Results. The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. Conclusions. The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.",

keywords = "Clinical trial, prostate neoplasm, retropubic radical prostatectomy, robot-assisted laparoscopic radical prostatectomy, study design, urological surgical procedures",

author = "Thordis Thorsteinsdottir and Johan Stranne and Stefan Carlsson and Bo Anderberg and Ingela Bj{\"o}rholt and Damber, {Jan Erik} and Jonas Hugosson and Ulrica Wilder{\aa}ng and Peter Wiklund and Gunnar Steineck and Eva Haglind",

note = "Funding Information: The authors are grateful to the members of the LAP-PRO steering committee and local investigators at the participating urology departments: Anders Bjartell, Malm{\"o} University Hospital; Ola Bratt, Helsingborg Hospital; Hans Boman, Alings{\aa}s Hospital; Christer Edlund, Kungsbacka Hospital; Sven Grundtman, Uddevalla Hospital; Ove Gustafsson, Karolinska University Hospital/Huddinge; Thomas Jiborn, Malm{\"o} University Hospital; Ingrid H{\"o}glund Karlsson, Sahlgrenska University Hospital; Ali Khatami, Sahlgrenska University Hospital; Mikael Lagerkvist, UroClinic Stockholm; Eric Pileblad, Capio Lundby Hospital; Mikael Sylme, Varberg Hospital; and Ulrika Westlund, S{\"o}dersjukhuset. The authors are also grateful to the personnel at the LAPPRO trial secretariat and the regional tumour registry and oncologic centre, Sahlgrenska University Hospital, for their essential input into the study procedure. Torgny Anderson at Interezza developed and supported technically the management of the patient-contact database. The trial is supported by grants from the Swedish Cancer Foundation, the West Gothia Region, Sahlgrenska University Hospital, Sanofi-Aventis and Mary von Sydow Foundation.",

year = "2011",

month = mar,

doi = "10.3109/00365599.2010.532506",

language = "English",

volume = "45",

pages = "102--112",

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Thorsteinsdottir, T, Stranne, J, Carlsson, S, Anderberg, B, Björholt, I, Damber, JE, Hugosson, J, Wilderång, U, Wiklund, P, Steineck, G & Haglind, E 2011, 'LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer', Scandinavian Journal of Urology and Nephrology, vol. 45, no. 2, pp. 102-112. https://doi.org/10.3109/00365599.2010.532506

TY - JOUR

T1 - LAPPRO

T2 - A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer

AU - Thorsteinsdottir, Thordis

AU - Stranne, Johan

AU - Carlsson, Stefan

AU - Anderberg, Bo

AU - Björholt, Ingela

AU - Damber, Jan Erik

AU - Hugosson, Jonas

AU - Wilderång, Ulrica

AU - Wiklund, Peter

AU - Steineck, Gunnar

AU - Haglind, Eva

N1 - Funding Information: The authors are grateful to the members of the LAP-PRO steering committee and local investigators at the participating urology departments: Anders Bjartell, Malmö University Hospital; Ola Bratt, Helsingborg Hospital; Hans Boman, Alingsås Hospital; Christer Edlund, Kungsbacka Hospital; Sven Grundtman, Uddevalla Hospital; Ove Gustafsson, Karolinska University Hospital/Huddinge; Thomas Jiborn, Malmö University Hospital; Ingrid Höglund Karlsson, Sahlgrenska University Hospital; Ali Khatami, Sahlgrenska University Hospital; Mikael Lagerkvist, UroClinic Stockholm; Eric Pileblad, Capio Lundby Hospital; Mikael Sylme, Varberg Hospital; and Ulrika Westlund, Södersjukhuset. The authors are also grateful to the personnel at the LAPPRO trial secretariat and the regional tumour registry and oncologic centre, Sahlgrenska University Hospital, for their essential input into the study procedure. Torgny Anderson at Interezza developed and supported technically the management of the patient-contact database. The trial is supported by grants from the Swedish Cancer Foundation, the West Gothia Region, Sahlgrenska University Hospital, Sanofi-Aventis and Mary von Sydow Foundation.

PY - 2011/3

Y1 - 2011/3

N2 - Objective: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. Material and methods. The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. Results. The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. Conclusions. The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.

AB - Objective: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. Material and methods. The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. Results. The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. Conclusions. The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.

KW - Clinical trial

KW - prostate neoplasm

KW - retropubic radical prostatectomy

KW - robot-assisted laparoscopic radical prostatectomy

KW - study design

KW - urological surgical procedures

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SN - 0036-5599

VL - 45

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EP - 112

JO - Scandinavian Journal of Urology and Nephrology

JF - Scandinavian Journal of Urology and Nephrology

IS - 2

ER -

LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer

Abstract

Bibliographical note

Other keywords

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