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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube; Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

• Registration Number: NCT04457882
• Lead Sponsor: Shanghai East Hospital

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.

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Study Start: 2023-08-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Drainage Tube	Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube	No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
With Drainage Tube	Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube	Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Primary Outcome Measures

Name	Time	Method
The rate of adverse event	3 month	Any adverse event according to the Clavien-Dindo classification will be recorded

Secondary Outcome Measures

Name	Time	Method
Intestinal function recovery	3 Months	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
Hemoglobin	3 Months	The difference between postoperative hemoglobin and preoperative hemoglobin
Abdominal effusion and cyst	3 Months	The ultrasound and CT to detect if there is abdominal effusion and cyst
Physical recovery	3 Months	The time between the patient's first time out of bed and the end of the surgical procedure

Trial Locations

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China