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This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.
This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men with localized prostate cancer. This study aims to determine whether intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without Drainage Tube | Experimental | No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy |
|
| With Drainage Tube | Active Comparator | Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube | Behavioral | No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of adverse event | Any adverse event according to the Clavien-Dindo classification will be recorded | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | The difference between postoperative hemoglobin and preoperative hemoglobin | 3 Months |
| Physical recovery | The time between the patient's first time out of bed and the end of the surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biming He | Contact | +8615502139410 | 190589109@qq.com | |
| Haifeng Wang | Contact | +8613681750891 | 446720864@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Haifeng Wang | Shanghai East Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Shanghai | Shanghai Municipality | 200120 | China |
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| Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube | Behavioral | Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy |
|
| 3 Months |
| Intestinal function recovery | The first time to eat after the operation, the first time to exit gas after the operation,the first time to defecation after the operation | 3 Months |
| Abdominal effusion and cyst | The ultrasound and CT to detect if there is abdominal effusion and cyst | 3 Months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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