Clinical trial · Interventional
Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer
A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
NCT01613651CI-TRIAL-00029524completedPhase 3ClinicalTrials.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 randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative complication management/prevention | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| robot-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (RALP)
- description
- Patients undergo RALP.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Other: questionnaire administration
- type
- EXPERIMENTAL
- label
- Arm II (RALP and placement of pelvic drain)
- description
- Patients undergo RALP and placement of pelvic drain.
- interventionNames
- Procedure: robot-assisted laparoscopic surgery
- Other: questionnaire administration
- Other: intraoperative complication management/prevention
Primary outcomes (1)
- measure
- Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients diagnosed with prostate cancer and scheduled to undergo RALP at City of Hope National Medical Center * Written informed consent obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services * Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria Exclusion Criteria: * Non-compliance * Prior radiotherapy to the pelvis or prostate * Prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon * Demonstrated intra-operative anastomotic leakage when irrigated with 120 mL of normal saline at the end of surgery * Intra-operative injuries (for example: rectal injury) * Inadequate hemostasis
References
Publications (0)
Data not yet available
No reference posted for this study.