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Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

12 lipca 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Oczekiwany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Wietnam
      • Ho Chi Minh City, Wietnam, 700000
        • Rekrutacyjny
        • Binh Dan Hospital
        • Kontakt:
          • Hoang PC Nguyen, Associate Professor, MD, PhD
          • Numer telefonu: +84 913 719 346
          • E-mail: npchoang@gmail.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Męski

Opis

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;

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Robotic-assisted surgery
Procedura: Radical prostatectomy
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
Pozorny komparator: Laparoscopic surgery
Procedura: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The console time
Ramy czasowe: During the surgery
The time which surgeon spends on the robot console by minuite
During the surgery
Mean of blood loss
Ramy czasowe: During the surgery
Milliliter
During the surgery
Perioperative transfusion rate (%)
Ramy czasowe: 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,
Ramy czasowe: 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
Ramy czasowe: 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 (%),
Ramy czasowe: 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),
Ramy czasowe: 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
Ramy czasowe: Up to 1 week after operation
(mg/mL)
Up to 1 week after operation
The drainage time
Ramy czasowe: Up to 3 months after surgery
(day),
Up to 3 months after surgery
To assess urethral catheter time, urethral catheter time
Ramy czasowe: Up to 3 months after surgery
(day)
Up to 3 months after surgery
To assess bowel movement recovery time,
Ramy czasowe: Up to 1 week after surgery
(day)
Up to 1 week after surgery
To assess postoperative hospital stay
Ramy czasowe: Up to 1 month after surgery
(day)
Up to 1 month after surgery
The rate of postoperative complications (including infections)
Ramy czasowe: 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
Ramy czasowe: Before operation
(mg/mL)
Before operation
PSA level in blood
Ramy czasowe: 6 weeks post-operation
(mg/mL)
6 weeks post-operation
PSA level in blood
Ramy czasowe: 3 months post-operation
(mg/mL)
3 months post-operation
PSA level in blood
Ramy czasowe: 6 months post-operation
(mg/mL)
6 months post-operation
PSA level in blood
Ramy czasowe: 12 months post-operation
(mg/mL)
12 months post-operation
local and regional recurrences on sonography
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Binh Dan Hospital

Śledczy

  • Dyrektor Studium: Hung V Tran, MD, PhD, Binh Dan Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2019

Zakończenie podstawowe (Oczekiwany)

31 grudnia 2020

Ukończenie studiów (Oczekiwany)

31 grudnia 2020

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 lipca 2019

Pierwszy wysłany (Rzeczywisty)

9 lipca 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 lipca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lipca 2020

Ostatnia weryfikacja

1 lipca 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BD022019

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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