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NCT Number: NCT04638088

Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Clinique Esquirol Saint Hilaire, Agen, France

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About this study

Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient hospitalized for a planned radical prostatectomy

Exclusion criteria

  • Consent refusal from the patient
  • Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
  • Absence of a French Health Care Insurance coverage

Treatment and study plan

assessment of urinary function and erectil function before and after prostatectomy

Other

assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete

Primary outcomes

  1. Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score

    Time frame: 45 Days after the surgery

    Comparison of the prostatectomy performed by robot assisted laparoscopy or conventional laparoscopy and by surgical laparotomy on the urinary function assessed by the EPIC 50 score (Expanded Prostate Cancer Index Composite)

Secondary outcomes

  1. impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy in radical prostatectomy on the erectile function assessed by the EPIC 50 score

    Time frame: 45 Days after the surgery

    impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy on the erectile function assessed by he EPIC 50 score (Expanded Prostate Cancer Index Composite)

  2. impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE

    Time frame: up to 5 years after surgery

  3. impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score

    Time frame: upt to 5 years after the surgery

  4. Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score

    Time frame: 12 months

    Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score

  5. Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )

    Time frame: 3 years

  6. Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )

    Time frame: 5 years

  7. Prostate Specific Antigen (PSA) level

    Time frame: up to 5 years

    measures of the level of PSA in a man's blood

Study contacts

Contact information is provided by the study sponsor or research team.

Shahnaz KLOUCHE, MD

CONTACT

[email protected]

00331 58 56 41 71

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.

Acronym: EMUPRO

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Nov 20, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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