A Prospective Randomized Trial of Pelvic Drain Placement Versus no Pelvic Drain Placement After Robotic Assisted Laparoscopic Prostatectomy (RALP) in Patients With Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 试验地点
- 2
- 主要终点
- Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (RALP)
Patients undergo RALP.
干预措施: robot-assisted laparoscopic surgery (Procedure)
Arm I (RALP)
Patients undergo RALP.
干预措施: questionnaire administration (Other)
Arm II (RALP and placement of pelvic drain)
Patients undergo RALP and placement of pelvic drain.
干预措施: robot-assisted laparoscopic surgery (Procedure)
Arm II (RALP and placement of pelvic drain)
Patients undergo RALP and placement of pelvic drain.
干预措施: questionnaire administration (Other)
Arm II (RALP and placement of pelvic drain)
Patients undergo RALP and placement of pelvic drain.
干预措施: intraoperative complication management/prevention (Other)
结局指标
主要结局
Incidence of early postoperative adverse events according to Common Terminology Criteria for Adverse Events 4.0 (CTCAE 4.0)
时间窗: Within 90 days from prostatectomy
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.
次要结局
- 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(Within 90 days post prostatectomy)
- Peri-operative outcomes for patients with and without a pelvic drain, including continence and potency(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(Within 90 days from prostatectomy)