Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Oczekiwany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Hoang PC Nguyen, Associate Professor, MD, PhD
- Numer telefonu: +84 913 719 346
- E-mail: npchoang@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Linh NK Tran, MD, PhD
- Numer telefonu: +84 989 047 088
- E-mail: khaclinh@gmail.com
Lokalizacje studiów
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Ho Chi Minh City, Wietnam, 700000
- Rekrutacyjny
- Binh Dan Hospital
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Kontakt:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Numer telefonu: +84 913 719 346
- E-mail: npchoang@gmail.com
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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;
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Aktywny komparator: Robotic-assisted surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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Pozorny komparator: Laparoscopic surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The console time
Ramy czasowe: During the surgery
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The time which surgeon spends on the robot console by minuite
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During the surgery
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Mean of blood loss
Ramy czasowe: During the surgery
|
Milliliter
|
During the surgery
|
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Perioperative transfusion rate (%)
Ramy czasowe: Up to 1 month after operation
|
The number of cases which will be transfused.
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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,
Ramy czasowe: Up to 1 week after operation
|
Number of cases, based on the result of pathology.
|
Up to 1 week after operation
|
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Number of blood units transfused
Ramy czasowe: Up to 1 week after operation
|
Milliliter
|
Up to 1 week after operation
|
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the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Ramy czasowe: Up to 1 weeks after the surgery.
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Percentage
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Up to 1 weeks after the surgery.
|
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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.
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Up to 3 month after surgery
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Change of hemoglobin from baseline
Ramy czasowe: Up to 1 week after operation
|
(mg/mL)
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Up to 1 week after operation
|
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The drainage time
Ramy czasowe: Up to 3 months after surgery
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(day),
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Up to 3 months after surgery
|
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To assess urethral catheter time, urethral catheter time
Ramy czasowe: Up to 3 months after surgery
|
(day)
|
Up to 3 months after surgery
|
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To assess bowel movement recovery time,
Ramy czasowe: Up to 1 week after surgery
|
(day)
|
Up to 1 week after surgery
|
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To assess postoperative hospital stay
Ramy czasowe: Up to 1 month after surgery
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(day)
|
Up to 1 month after surgery
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The rate of postoperative complications (including infections)
Ramy czasowe: 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.
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PSA level in blood
Ramy czasowe: Before operation
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(mg/mL)
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Before operation
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PSA level in blood
Ramy czasowe: 6 weeks post-operation
|
(mg/mL)
|
6 weeks post-operation
|
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PSA level in blood
Ramy czasowe: 3 months post-operation
|
(mg/mL)
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3 months post-operation
|
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PSA level in blood
Ramy czasowe: 6 months post-operation
|
(mg/mL)
|
6 months post-operation
|
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PSA level in blood
Ramy czasowe: 12 months post-operation
|
(mg/mL)
|
12 months post-operation
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local and regional recurrences on sonography
Ramy czasowe: through study completion, an average of 1 year
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including ultrasound when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on MRI
Ramy czasowe: through study completion, an average of 1 year
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including MRI when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on PET Scan
Ramy czasowe: through study completion, an average of 1 year
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including PET Scan, when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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.
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Preoperative
|
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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.
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3 months postoperative
|
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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.
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6 months, postoperative
|
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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.
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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.
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3 months, postoperative
|
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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
|
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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
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Hung V Tran, MD, PhD, Binh Dan Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Zakończenie podstawowe
Ukończenie studiów (Oczekiwany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- BD022019
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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