NCT01613651

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine if eliminating placement of a pelvic drain in patients during robotic assisted laparoscopic prostatectomy (RALP) increases incidence of early postoperative adverse events occurring within 90 days from prostatectomy, compared to patients who have a pelvic drain placed during RALP. SECONDARY OBJECTIVES: I. To determine the incidence of early postoperative adverse events in patients with and without a pelvic drain when adjustments to confounders associated with these events are made (confounders: demographic, surgical and pathologic; age, body mass index \[BMI\], pathologic stage, Gleason sum, extent of lymph node dissection). II. To report peri-operative and postoperative outcomes, including but not limited to, length of hospital stay, re-admissions, continence, potency and incidence of medical interventions for patients with and without pelvic drain. III. To compare early postoperative adverse event rates between patients with and without a pelvic drain in patients who had extended pelvic lymph node dissection during RALP. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo RALP. ARM II: Patients undergo RALP and placement of pelvic drain. After completion of treatment, patients are followed up at 1 week and then 1, 3, 6, 9, and 12 months.

Conditions

• Perioperative/Postoperative Complications
• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	robot-assisted laparoscopic surgery	Undergo RALP
OTHER	questionnaire administration	Ancillary studies
OTHER	intraoperative complication management/prevention	Undergo placement of pelvic drain

Timeline

• Start date: 2012-08-24
• Primary completion: 2017-09-11
• Completion: 2017-09-11
• First posted: 2012-06-07
• Last updated: 2017-09-14

Locations

1 site across 1 country: United States