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

Tongji University

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube; Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT04457882

PD2020-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Without Drainage Tube

Experimental group

Description:

No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Treatment:

Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

With Drainage Tube

Active Comparator group

Description:

Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Treatment:

Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube