Clinical trial · Interventional
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube
Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study
NCT04457882CI-TRIAL-00061787unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube | Behavioral | — | UNRESOLVED |
| Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Without Drainage Tube
- description
- No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
- interventionNames
- Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
- type
- ACTIVE_COMPARATOR
- label
- With Drainage Tube
- description
- Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
- interventionNames
- Behavioral: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube
Primary outcomes (1)
- measure
- The rate of adverse event
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.