- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04011865
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
12 июля 2020 г. обновлено: 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.
Обзор исследования
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
80
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Ho Chi Minh City, Вьетнам, 700000
- Рекрутинг
- Binh Dan Hospital
-
Контакт:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Номер телефона: +84 913 719 346
- Электронная почта: npchoang@gmail.com
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Мужской
Описание
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;
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Активный компаратор: 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.
|
Фальшивый компаратор: Laparoscopic surgery
|
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
The console time
Временное ограничение: During the surgery
|
The time which surgeon spends on the robot console by minuite
|
During the surgery
|
Mean of blood loss
Временное ограничение: During the surgery
|
Milliliter
|
During the surgery
|
Perioperative transfusion rate (%)
Временное ограничение: 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,
Временное ограничение: 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
Временное ограничение: 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 (%),
Временное ограничение: 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),
Временное ограничение: 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
Временное ограничение: Up to 1 week after operation
|
(mg/mL)
|
Up to 1 week after operation
|
The drainage time
Временное ограничение: Up to 3 months after surgery
|
(day),
|
Up to 3 months after surgery
|
To assess urethral catheter time, urethral catheter time
Временное ограничение: Up to 3 months after surgery
|
(day)
|
Up to 3 months after surgery
|
To assess bowel movement recovery time,
Временное ограничение: Up to 1 week after surgery
|
(day)
|
Up to 1 week after surgery
|
To assess postoperative hospital stay
Временное ограничение: Up to 1 month after surgery
|
(day)
|
Up to 1 month after surgery
|
The rate of postoperative complications (including infections)
Временное ограничение: 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
Временное ограничение: Before operation
|
(mg/mL)
|
Before operation
|
PSA level in blood
Временное ограничение: 6 weeks post-operation
|
(mg/mL)
|
6 weeks post-operation
|
PSA level in blood
Временное ограничение: 3 months post-operation
|
(mg/mL)
|
3 months post-operation
|
PSA level in blood
Временное ограничение: 6 months post-operation
|
(mg/mL)
|
6 months post-operation
|
PSA level in blood
Временное ограничение: 12 months post-operation
|
(mg/mL)
|
12 months post-operation
|
local and regional recurrences on sonography
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Hung V Tran, MD, PhD, Binh Dan Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 января 2019 г.
Первичное завершение (Ожидаемый)
31 декабря 2020 г.
Завершение исследования (Ожидаемый)
31 декабря 2020 г.
Даты регистрации исследования
Первый отправленный
13 мая 2019 г.
Впервые представлено, что соответствует критериям контроля качества
4 июля 2019 г.
Первый опубликованный (Действительный)
9 июля 2019 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 июля 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июля 2020 г.
Последняя проверка
1 июля 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BD022019
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Radical prostatectomy
-
Trakya UniversityЗавершенныйИндекс перфузии | Однолегочная вентиляция | Гипоксемия во время операции | Индекс кислородного резерва | Индекс изменчивости плетиТурция
-
Johannes Gutenberg University MainzЗавершенный
-
University of ChicagoОтозван
-
Zonguldak Bulent Ecevit UniversityЗавершенныйСвежий поток | КарбоксигемоглобинемияТурция
-
Pamela PetersenЗавершенный
-
Hopital FochЗавершенный
-
Cairo UniversityAbdelhamid, Bassant Mohamed, M.D.; Mohamed, Ahmed A., M.D.; Ashraf Mohamed Abd Elmawgod и другие соавторыЗавершенныйРадикальный импульсный кооксиметр Masimo в практике интраоперационного переливания крови во время акушерской операцииЕгипет
-
George Washington UniversityАктивный, не рекрутирующий
-
Antalya Training and Research HospitalЗавершенныйОсложнения кесарева сеченияТурция
-
Kasr El Aini HospitalНеизвестныйДородовое кровотечение