Are You in a Poor Country; HIPEC is Still in Reach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Thermal efficiency of the machine
研究概览
简要总结
Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy.
On introduction of the new concept of combined optimal cytoreduction (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.
A major obstacle which may face application of HIPEC manoeuvre is the cost either of the machine or the disposable kit used in handling the chemotherapy, heating it and delivering it to the patient, hence we established our machine design with its disposable kits making it available for use in poor places.
详细描述
As aforementioned the use of HIPEC technique offered a promising results in dealing with peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor places so we inented a machine with considerably lower costs both in the machine composition and its disposable kit used for every patient we used it for six years in a trial to find any shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the published data of the standard machines
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient candidate for HIPEC procedure
排除标准
- •Contraindications to HIPEC procedure
结局指标
主要结局
Thermal efficiency of the machine
时间窗: 6 years of the study using the machine
The ability of the machine to warm the chemoperfusate to 43 c for 90 minutes (the duration of peritoneal perfusion)
Electrical efficiency of the machine
时间窗: 6 years of the study using the machine
Reporting any interruption or unexplained stop of the thermostat resulting in stopping of chemoperfusate flow to and out of the abdomen during the 90 minutes of the maneuver
The manufacturing costs in US dollar
时间窗: one weak at the start of the trial
the costs paid by the owner of manufacturing the machine throughout collecting its components and technical fitting them into a machine
The disposable costs in US dollar
时间窗: 6 years of the study using the machine
the costs spent by the patient at each use paid for the disposable parts of the machine of the chemotherapy perfusion circuit to and from the patient
次要结局
- Adverse effects on the patient following HIPEC(4 weeks)
研究者
Mohamed I Abdelhamid
Associate professor
Zagazig University