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

City of Hope

Status and phase: Completed; Phase 3

Conditions: Perioperative/Postoperative Complications; Prostate Cancer

Treatments: Other: questionnaire administration; Procedure: robot-assisted laparoscopic surgery; Other: intraoperative complication management/prevention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01613651

11113 (Registry Identifier)

NCI-2012-00558 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 191 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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191 participants in 2 patient groups

Arm I (RALP)

Experimental group

Description:

Patients undergo RALP.

Treatment:

Procedure: robot-assisted laparoscopic surgery

Other: questionnaire administration

Arm II (RALP and placement of pelvic drain)

Experimental group

Description:

Patients undergo RALP and placement of pelvic drain.

Treatment:

Procedure: robot-assisted laparoscopic surgery

Other: intraoperative complication management/prevention

Other: questionnaire administration