Prostate Cancer
Conditions
Keywords
Prostate Cancer, Laparoscopic Radical Prostatectomy, Intraperitoneal, Drainage Tube
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
BEHAVIORALIntraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube
Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. age: more than 18 years old, less than 85 years old; 2. Patient who pathologically diagnosed with prostate cancer and plan to undergo radical laparoscopic surgery for prostate cancer; 3. fully understand the clinical trial protocol and sign the informed consent;
Exclusion criteria
1. patients with surgical contraindications who cannot accept surgery; 2. patients with non-laparoscopic radical resection of prostate cancer; 3. patients with previous pelvic radiation therapy and complicated abdominal surgery; 4. patients judged by the investigator to be unsuitable to participate in the clinical trial;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of adverse event | 3 month | Any adverse event according to the Clavien-Dindo classification will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical recovery | 3 Months | The time between the patient's first time out of bed and the end of the surgical procedure |
| Hemoglobin | 3 Months | The difference between postoperative hemoglobin and preoperative hemoglobin |
| Intestinal function recovery | 3 Months | 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 |
| Abdominal effusion and cyst | 3 Months | The ultrasound and CT to detect if there is abdominal effusion and cyst |
Countries
China
Contacts
Primary ContactBiming He
Backup ContactHaifeng Wang
Outcome results
None listed