Are You in a Poor Country; HIPEC is Still in Reach

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Are You in a Poor Country; HIPEC is Still in Reach

Conditions
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HIPEC

Intervention / Treatment
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* Device: HIPEC device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient candidate for HIPEC procedure Exclusion Criteria: Contraindications to HIPEC procedure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with Peritoneal carcinomatosis<br>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. | Device: HIPEC device<br>* To report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal efficiency of the machine | The ability of the machine to warm the chemoperfusate to 43 c for 90 minutes (the duration of peritoneal perfusion) | 6 years of the study using the machine | 
| Electrical efficiency of 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 | 6 years of the study using the machine | 
| The manufacturing costs in US dollar | the costs paid by the owner of manufacturing the machine throughout collecting its components and technical fitting them into a machine | one weak at the start of the trial | 
| The disposable costs in US dollar | 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 | 6 years of the study using the machine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects on the patient following HIPEC | following the patient in the postoperative period searching for adverse effects of HIPEC resulting from either the chemotherapy used or the physical activity of the machine | 4 weeks |