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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

Neznámý

Podmínky

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

Intervenční

Zápis (Očekávaný)

80

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 místa

  • Vietnam
      • 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

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Mužský

Popis

Inclusion Criteria:

  1. Adult men aged 18 years and over;
  2. Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
  3. Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
  4. Cognitively able to give written informed consent for participation;
  5. Elective procedure.

Exclusion Criteria:

  1. The patient lacks the ability to consent for themselves;
  2. 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)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Robotic-assisted surgery
Postup: Radical prostatectomy
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
Postup: Radical prostatectomy
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

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
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
To assess bowel movement recovery time,
Časové okno: Up to 1 week after surgery
(day)
Up to 1 week after surgery
To assess postoperative hospital stay
Časové okno: Up to 1 month after surgery
(day)
Up to 1 month after surgery
The rate of postoperative complications (including infections)
Časové okno: in day 3, day 7, and 1 month after surgery.
Percentage
in day 3, day 7, and 1 month after surgery.
PSA level in blood
Časové okno: Before operation
(mg/mL)
Before operation
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
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
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
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

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

Binh Dan Hospital

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)

1. ledna 2019

Primární dokončení (Očekávaný)

31. prosince 2020

Dokončení studie (Očekávaný)

31. prosince 2020

Termíny zápisu do studia

První předloženo

13. května 2019

První předloženo, které splnilo kritéria kontroly kvality

4. července 2019

První zveřejněno (Aktuální)

9. července 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. července 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. července 2020

Naposledy ověřeno

1. července 2020

Více informací

Termíny související s touto studií

Klíčová slova

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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