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

NCT04457882 | Unknown DMC

• 1 other identifier: PD2020-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Laparoscopic Radical Prostatectomy; Intraperitoneal; Drainage Tube

Outcome Measures

Primary Outcomes (1)

• The rate of adverse event

  Any adverse event according to the Clavien-Dindo classification will be recorded

  3 month

Secondary Outcomes (4)

• Hemoglobin

  3 Months

• Physical recovery

  3 Months

• Intestinal function recovery

  3 Months

• Abdominal effusion and cyst

  3 Months

Study Arms (2)

Without Drainage Tube

EXPERIMENTAL

No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

With Drainage Tube

ACTIVE COMPARATOR

Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

Interventions

Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube BEHAVIORAL

No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

Without Drainage Tube

Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube BEHAVIORAL

Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

With Drainage Tube

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: more than 18 years old, less than 85 years old;
• Patient who pathologically diagnosed with prostate cancer and plan to undergo radical laparoscopic surgery for prostate cancer;
• fully understand the clinical trial protocol and sign the informed consent;

You may not qualify if:

• patients with surgical contraindications who cannot accept surgery;
• patients with non-laparoscopic radical resection of prostate cancer;
• patients with previous pelvic radiation therapy and complicated abdominal surgery;
• patients judged by the investigator to be unsuitable to participate in the clinical trial;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Haifeng Wang

  Shanghai East Hospital,Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biming He

CONTACT

+8615502139410; 190589109@qq.com

Haifeng Wang

CONTACT

+8613681750891; 446720864@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

CN (1)