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Status unknownNCT04457882Updated Oct 28, 2022

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

An interventional study of Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube and Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube in Prostate Cancer, sponsored by Shanghai East Hospital. Status unknown at 1 site in China. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Shanghai East Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Male
01

Study 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.

Read the 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
  • Laparoscopic Radical Prostatectomy
  • Intraperitoneal
  • Drainage Tube
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 112 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Shanghai East Hospital is the lead sponsor of 92 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Without Drainage Tube

    No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

    Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

  • Active comparator
    With Drainage Tube

    Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy

    Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

Interventions

  • BehavioralIntraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube

    No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

  • BehavioralIntraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube

    Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy

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What researchers measure

Primary outcomes

  1. The rate of adverse event

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

    Time frame: 3 month

Secondary outcomes

  1. Hemoglobin

    The difference between postoperative hemoglobin and preoperative hemoglobin

    Time frame: 3 Months

  2. Physical recovery

    The time between the patient's first time out of bed and the end of the surgical procedure

    Time frame: 3 Months

  3. 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

    Time frame: 3 Months

  4. Abdominal effusion and cyst

    The ultrasound and CT to detect if there is abdominal effusion and cyst

    Time frame: 3 Months

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04457882
Lead sponsor
Shanghai East Hospital
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Aug 1, 2023 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Oct 28, 2022

Study contacts

Biming He
Contact
190589109@qq.com
+8615502139410
Haifeng Wang
Contact
446720864@qq.com
+8613681750891
Haifeng Wang
principal investigator · Shanghai East Hospital,Tongji University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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