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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer

Conditions
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Perioperative/Postoperative Complications, Prostate Cancer

Intervention / Treatment
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* Procedure: robot-assisted laparoscopic surgery
* Other: questionnaire administration
* Other: intraoperative complication management/prevention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (RALP)<br>Patients undergo RALP. | Procedure: robot-assisted laparoscopic surgery<br>* Undergo RALP<br>Other: questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Arm II (RALP and placement of pelvic drain)<br>Patients undergo RALP and placement of pelvic drain. | Procedure: robot-assisted laparoscopic surgery<br>* Undergo RALP<br>Other: questionnaire administration<br>* Ancillary studies<br>Other: intraoperative complication management/prevention<br>* Undergo placement of pelvic drain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0) | The observed rate of adverse events among patients on the two arms of the study will be compared using a one-sided non-inferiority test with the intent to rule out a 10% or greater difference in postoperative adverse event rates. | Within 90 days from prostatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early postoperative adverse events in patients with and without pelvic drain with adjustments applied to confounders associated with these events according to CTCAE 4.0 | Further analysis will be conducted using multivariate logistic regression, to determine whether the odds of early postoperative adverse events are significantly different for patients in different study arms, once they have controlled for confounding prognostic factors, such as age, BMI, pathologic stage, Gleason sum, and lymph node dissection template. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test. | Within 90 days post prostatectomy | 
| Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency | Survival analysis will be used to determine if there is any significant difference between patients on two arms of the study with respect to time to continence or potency. Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test. | Up to 12 months | 
| Incidence of early postoperative adverse events from prostatectomy in patients with and without a pelvic drain who had an extended pelvic lymph node dissection during RALP according to CTCAE 4.0 | Secondary postoperative categorical or continuous endpoints will be examined between arm I and arm II and will be analyzed using the Chi Square T-test, the Mann Whitney test, or the two-sided t-test. | Within 90 days from prostatectomy |