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临床试验/NCT03630393
NCT03630393终止不适用

Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System

OhioHealth1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
OhioHealth
入组人数
170
试验地点
1
主要终点
Postoperative Pain Medication Use

研究概览

简要总结

The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.

详细描述

The investigators to examine the impact of low pressure during robotic assisted laparoscopic prostatectomy (RALP) with the intention of identifying whether lower pressures might benefit participants. The investigators hypothesize that a low insufflation pressure may provide an improvement in postoperative pain and abdominal distension in addition to potential physiologic benefits, and that these factors might then allow a shorter hospital stay. The investigators previously initiated a protocol in September of 2016 (IRB# 1066864) to perform RALPs at an insufflation pressure of 6 mmHg with the intention of increasing the pressure as needed on an individual participant level. In order to determine whether this might allow earlier discharge when successful, the investigators began allowing for same-day discharge in participants meeting appropriate criteria. Having now demonstrated feasibility in over 300 consecutive participants using this ultralow pneumoperitoneum protocol, the investigators now plan to conduct a randomized trial to compare a pressure of 6 mmHg with participants having RALP at a standard pressure of 15 mmHg to determine whether there is a true benefit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • •Age 18 or older
  • •Diagnosed with prostate cancer
  • •Electing to undergo robotic assisted laparoscopic prostatectomy (RALP)

排除标准

  • •Emergency surgery
  • •Patients with a significant preoperative dependence on narcotic medications
  • •Unable to give informed consent
  • •Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
  • •Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results)
  • •Non-English-speaking or reading

研究组 & 干预措施

Pressure 6 mmHg

Experimental

Pneumoperitoneum Pressure 6 mmHg

干预措施: Pneumoperitoneum Pressure 6 mmHg (Other)

Pressure 15 mmHg

Active Comparator

Pneumoperitoneum Pressure 15 mmHg

干预措施: Pneumoperitoneum Pressure 15 mmHg (Other)

结局指标

主要结局

Postoperative Pain Medication Use

时间窗: Through 1 week postoperatively

The cumulative dose (milligrams) of each opioid medication administered was calculated and converted to milligram morphine equivalents (MME) for each participant.

次要结局

  • Post Operative Pain Scores(Through discharge (post-operative day 0 or post-operative day 1))
  • Operative Ventilation(Intraoperatively)
  • Discharge Day (Post-operative Day 0 or 1)(Through discharge (post-operative day 0 or 1))

研究者

发起方
OhioHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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