Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer

Completed · Phase 3

Conditions studied: Perioperative/Postoperative Complications, Prostate Cancer

In brief

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.

Key facts

Study ID: NCT01613651
Run by: City of Hope Medical Center
People needed: 191
Starts: 2012-08-24
Expected to finish: 2017-09-11
Last updated by the study team: 2017-09-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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