Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
* Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: more than 18 years old, less than 85 years old; Patient who pathologically diagnosed with prostate cancer and plan to undergo radical laparoscopic surgery for prostate cancer; fully understand the clinical trial protocol and sign the informed consent; Exclusion Criteria: patients with surgical contraindications who cannot accept surgery; patients with non-laparoscopic radical resection of prostate cancer; patients with previous pelvic radiation therapy and complicated abdominal surgery; patients judged by the investigator to be unsuitable to participate in the clinical trial;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Without Drainage Tube<br>No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy | Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube<br>* No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy<br>|
| Active Comparator: With Drainage Tube<br>Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy | Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube<br>* Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of adverse event | Any adverse event according to the Clavien-Dindo classification will be recorded | 3 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Laparoscopic Radical Prostatectomy, Intraperitoneal, Drainage Tube