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

NCT ID: NCT01613651

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-24
• Study Completion Date: 2017-09-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm I (RALP)

Patients undergo RALP.

Group Type: EXPERIMENTAL

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo RALP

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Arm II (RALP and placement of pelvic drain)

Patients undergo RALP and placement of pelvic drain.

Group Type: EXPERIMENTAL

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo RALP

questionnaire administration

Intervention Type: OTHER

Ancillary studies

intraoperative complication management/prevention

Intervention Type: OTHER

Undergo placement of pelvic drain

Interventions

robot-assisted laparoscopic surgery

Undergo RALP

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

intraoperative complication management/prevention

Undergo placement of pelvic drain

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Yamzon

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2012-00558

Identifier Type: REGISTRY

Identifier Source: secondary_id

11113

Identifier Type: -

Identifier Source: org_study_id