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

NCT ID: NCT04457882

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-10-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Without Drainage Tube

No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Group Type EXPERIMENTAL

Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

Intervention Type BEHAVIORAL

No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

With Drainage Tube

Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Group Type ACTIVE_COMPARATOR

Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

Intervention Type BEHAVIORAL

Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Interventions

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Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Intervention Type BEHAVIORAL

Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haifeng Wang

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital,Tongji University School of Medicine

Locations

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Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Biming He

Role: CONTACT

+8615502139410

Haifeng Wang

Role: CONTACT

+8613681750891

Other Identifiers

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PD2020-001

Identifier Type: -

Identifier Source: org_study_id

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