Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
City of Hope Medical Center
With
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
