Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
12. července 2020 aktualizováno: Binh Dan Hospital
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Přehled studie
Postavení
Postavení
Neznámý
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon.
All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes.
These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.
Typ studie
Typ studie
Intervenční
Zápis (Očekávaný)
Zápis
80
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Hoang PC Nguyen, Associate Professor, MD, PhD
- Telefonní číslo: +84 913 719 346
- E-mail: npchoang@gmail.com
Studijní záloha kontaktů
- Jméno: Linh NK Tran, MD, PhD
- Telefonní číslo: +84 989 047 088
- E-mail: khaclinh@gmail.com
Studijní místa
-
-
-
Ho Chi Minh City, Vietnam, 700000
- Nábor
- Binh Dan Hospital
-
Kontakt:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Telefonní číslo: +84 913 719 346
- E-mail: npchoang@gmail.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
Inclusion Criteria:
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
Exclusion Criteria:
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: Robotic-assisted surgery
|
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
|
|
Falešný srovnávač: Laparoscopic surgery
|
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The console time
Časové okno: During the surgery
|
The time which surgeon spends on the robot console by minuite
|
During the surgery
|
|
Mean of blood loss
Časové okno: During the surgery
|
Milliliter
|
During the surgery
|
|
Perioperative transfusion rate (%)
Časové okno: Up to 1 month after operation
|
The number of cases which will be transfused.
|
Up to 1 month after operation
|
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The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Časové okno: Up to 1 week after operation
|
Number of cases, based on the result of pathology.
|
Up to 1 week after operation
|
|
Number of blood units transfused
Časové okno: Up to 1 week after operation
|
Milliliter
|
Up to 1 week after operation
|
|
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Časové okno: Up to 1 weeks after the surgery.
|
Percentage
|
Up to 1 weeks after the surgery.
|
|
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
Časové okno: Up to 3 month after surgery
|
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain.
The mean score will be calculated to reflect the post-operative pain.
|
Up to 3 month after surgery
|
|
Change of hemoglobin from baseline
Časové okno: Up to 1 week after operation
|
(mg/mL)
|
Up to 1 week after operation
|
|
The drainage time
Časové okno: Up to 3 months after surgery
|
(day),
|
Up to 3 months after surgery
|
|
To assess urethral catheter time, urethral catheter time
Časové okno: Up to 3 months after surgery
|
(day)
|
Up to 3 months after surgery
|
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To assess bowel movement recovery time,
Časové okno: Up to 1 week after surgery
|
(day)
|
Up to 1 week after surgery
|
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To assess postoperative hospital stay
Časové okno: Up to 1 month after surgery
|
(day)
|
Up to 1 month after surgery
|
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The rate of postoperative complications (including infections)
Časové okno: in day 3, day 7, and 1 month after surgery.
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Percentage
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in day 3, day 7, and 1 month after surgery.
|
|
PSA level in blood
Časové okno: Before operation
|
(mg/mL)
|
Before operation
|
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PSA level in blood
Časové okno: 6 weeks post-operation
|
(mg/mL)
|
6 weeks post-operation
|
|
PSA level in blood
Časové okno: 3 months post-operation
|
(mg/mL)
|
3 months post-operation
|
|
PSA level in blood
Časové okno: 6 months post-operation
|
(mg/mL)
|
6 months post-operation
|
|
PSA level in blood
Časové okno: 12 months post-operation
|
(mg/mL)
|
12 months post-operation
|
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local and regional recurrences on sonography
Časové okno: through study completion, an average of 1 year
|
including ultrasound when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
|
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local and regional recurrences, on MRI
Časové okno: through study completion, an average of 1 year
|
including MRI when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
|
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local and regional recurrences, on PET Scan
Časové okno: through study completion, an average of 1 year
|
including PET Scan, when PSA rising or any indication of recurrent
|
through study completion, an average of 1 year
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Časové okno: Preoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
Preoperative
|
|
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
Časové okno: 3 months postoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
3 months postoperative
|
|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Časové okno: 6 months, postoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
6 months, postoperative
|
|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Časové okno: 12 months postoperative.
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
|
12 months postoperative.
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Časové okno: Preoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
Preoperative
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Časové okno: 3 months, postoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
3 months, postoperative
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Časové okno: 6 months, postoperative.
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
6 months, postoperative.
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Časové okno: 12 months postoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
12 months postoperative
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Časové okno: Preoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
Preoperative
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Časové okno: 3 months, postoperative.
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
3 months, postoperative.
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Časové okno: 6 months, postoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
6 months, postoperative
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Časové okno: 12 months postoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
12 months postoperative
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Hung V Tran, MD, PhD, Binh Dan Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
1. ledna 2019
Primární dokončení (Očekávaný)
Primární dokončení
31. prosince 2020
Dokončení studie (Očekávaný)
Dokončení studie
31. prosince 2020
Termíny zápisu do studia
První předloženo
První předloženo
13. května 2019
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
4. července 2019
První zveřejněno (Aktuální)
První zveřejněno
9. července 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
14. července 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. července 2020
Naposledy ověřeno
Naposledy ověřeno
1. července 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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