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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube; Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Biming He; Phone Number: +8615502139410; Email: 190589109@qq.com
• Study Contact Backup: Name: Haifeng Wang; Phone Number: +8613681750891; Email: 446720864@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital, Tongji University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Principal Investigator: haifeng wang, Shanghai East Hospital,Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Intraperitoneal; Prostate Cancer; Laparoscopic Radical Prostatectomy; Drainage Tube
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PD2020-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No