Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy (RoboProstate)
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01577836
First received: April 13, 2012
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
The main objective of the study is to estimate and compare the overall cost of care of patients over 24 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.
| Condition |
|---|
|
Prostatic Neoplasms |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- Overall cost (€) of patient care [ Time Frame: 24 months ] [ Designated as safety issue: No ]Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 2 years. All medical resources consumed will be evaluated during the first 2 years after surgery.
Secondary Outcome Measures:
- Cost (€) of surgery via micro-costing [ Time Frame: Day 1 ] [ Designated as safety issue: No ]All human and material resources necessary for carrying out a prostatectomy will be evaluated.
- Change in erectile function [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]the International Index of Erectile Function (IIEF-15) will be used.
- Change in erectile function [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]the International Index of Erectile Function (IIEF-15) will be used.
- Change in erectile function [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]the International Index of Erectile Function (IIEF-15) will be used.
- Change in erectile function [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]the International Index of Erectile Function (IIEF-15) will be used.
- the % of positive margins after resection [ Time Frame: baseline (Day 1) ] [ Designated as safety issue: Yes ]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
- Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
- Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
- Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
- Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
- Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
- Presence/absence of complications (Clavien) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)
- Presence/absence of complications (Clavien) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)
- Presence/absence of complications (Pentafecta) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]The Pentafecta classification will be used.
- Presence/absence of complications (Pentafecta) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]The Pentafecta classification will be used.
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Robotic assistance, Nîmes
The patients in this group will undergo robot-assisted radial prostatectomy at the University Hospital of Nîmes.
|
|
Laparotomy, Marseilles
The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.
|
Detailed Description:
The secondary objectives of this research are to compare the following between the two groups:
- The actual cost of the surgical prostatectomy.
- Erectile function at 0, 1, 6, 12 and 24
- Oncological results at 1, 6, 12 and 24 months.
- Functional results at 0, 1, 6, 12 and 24 months.
- Quality of life at 0, 1, 6, 12 and 24 months.
- Complication rates at 1 and 24 months.
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Men between the ages of 45 and 75 and who have been diagnosed with localised prostate cancer. The treatment option retained is radical prostatectomy.
Criteria
Inclusion Criteria:
- The patient must have given his informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 24 months of follow up
- Patient has localised prostate cancer
- Patient is eligible for radical prostatectomy
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- Patient has a contraindication for a treatment necessary for this study
- Patients with psychiatric disorders
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577836
Contacts
| Contact: Stéphane Droupy, MD PhD | +33.(0)4.66.68.37.17 | stephane.droupy@chu-nimes.fr |
| Contact: Carey Suehs, PhD | +33.(0)4.66.68.67.88 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| APHM - Hôpital de la Conception | Recruiting |
| Marseille Cedex 5, France, 13385 | |
| Sub-Investigator: Eric Lechevallier, MD PhD | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Recruiting |
| Nîmes Cedex 09, France, 30029 | |
| Principal Investigator: Stephane Droupy, MD PhD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Stéphane Droupy, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01577836 History of Changes |
| Other Study ID Numbers: | AOI/2011/SD-03, 2011-A01385-36 |
| Study First Received: | April 13, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
Radical prostatectomie Robotic assistance Laparotomy |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013