NCT04457882

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube	No 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

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2020-07-07
• Last updated: 2022-10-28

Locations

1 site across 1 country: China