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

October 26, 2022 updated by: Shanghai East Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai East Hospital, Tongji University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Without Drainage Tube
No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
Active Comparator: With Drainage Tube
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of adverse event
Time Frame: 3 month
Any adverse event according to the Clavien-Dindo classification will be recorded
3 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Investigators

  • Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD2020-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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