Status:

UNKNOWN

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

Lead Sponsor:

Shanghai East Hospital

Conditions:

Prostate Cancer

Eligibility:

MALE

18-85 years

Phase:

NA

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 prostat...

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 lapar...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

August 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2024

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT04457882

Start Date

August 1 2023

End Date

October 1 2024

Last Update

October 28 2022

Active Locations (1)

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Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China, 200120