Back to resultsEvaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube
Primary Purpose
Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Laparoscopic Radical Prostatectomy, Intraperitoneal, Drainage Tube
Eligibility Criteria
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;
Sites / Locations
- Shanghai East Hospital, Tongji University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Without Drainage Tube
With Drainage Tube
Arm Description
No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
Outcomes
Primary Outcome Measures
The rate of adverse event
Any adverse event according to the Clavien-Dindo classification will be recorded
Secondary Outcome Measures
Hemoglobin
The difference between postoperative hemoglobin and preoperative hemoglobin
Physical recovery
The time between the patient's first time out of bed and the end of the surgical procedure
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
Abdominal effusion and cyst
The ultrasound and CT to detect if there is abdominal effusion and cyst
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457882
Brief Title
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube
Official Title
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Laparoscopic Radical Prostatectomy, Intraperitoneal, Drainage Tube
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Without Drainage Tube
Arm Type
Experimental
Arm Description
No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
Arm Title
With Drainage Tube
Arm Type
Active Comparator
Arm Description
Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
Intervention Type
Behavioral
Intervention Name(s)
Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
Intervention Description
No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
Intervention Type
Behavioral
Intervention Name(s)
Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube
Intervention Description
Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
Primary Outcome Measure Information:
Title
The rate of adverse event
Description
Any adverse event according to the Clavien-Dindo classification will be recorded
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
The difference between postoperative hemoglobin and preoperative hemoglobin
Time Frame
3 Months
Title
Physical recovery
Description
The time between the patient's first time out of bed and the end of the surgical procedure
Time Frame
3 Months
Title
Intestinal function recovery
Description
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
Time Frame
3 Months
Title
Abdominal effusion and cyst
Description
The ultrasound and CT to detect if there is abdominal effusion and cyst
Time Frame
3 Months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biming He
Phone
+8615502139410
Email
190589109@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng Wang
Phone
+8613681750891
Email
446720864@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang
Organizational Affiliation
Shanghai East Hospital,Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Tongji University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube
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