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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04457882
• Other study ID #: PD2020-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2022
• Source: Shanghai East Hospital
• Contact: Biming He
• Phone: +8615502139410
• Email: 190589109[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
• Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube
Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of adverse event	Any adverse event according to the Clavien-Dindo classification will be recorded	3 month
Secondary	Hemoglobin	The difference between postoperative hemoglobin and preoperative hemoglobin	3 Months
Secondary	Physical recovery	The time between the patient's first time out of bed and the end of the surgical procedure	3 Months
Secondary	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
Secondary	Abdominal effusion and cyst	The ultrasound and CT to detect if there is abdominal effusion and cyst	3 Months