An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Study Overview
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Brief Summary
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Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis. CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.

Official Title
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A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)

Conditions
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Colorectal Cancer, Ovarian Cancer, Peritoneal Disease

Intervention / Treatment
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* Other: Hyperthermic intraperitoneal chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 70 years ASA Class I to III Colorectal and gynecological oncology cases posted for CRS with HIPC. Exclusion Criteria: Age less than 18 and more than 70 years ASA Class IV and above

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Hyperthermic intraperitoneal chemotherapy|Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in invasive blood pressure in perioperative period | Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner | From start of surgery upto 48 hours after surgery | 
| Changes in body temperature in perioperative period | Body temperature will be measured in degree centigrade by nasopharyngeal temperature probe in perioperative period and changes from baseline will be recorded in a graphical manner | From start of surgery upto 48 hours after surgery | 
| Changes in cardiac output in perioperative period | Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner | From start of surgery upto 48 hours after surgery | 
| Changes in arterial blood gas in perioperative period | Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner | From start of surgery upto 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in intensive care unit | Length of stay will be measured in days from admission to discharge in intensive care unit | Upto 30 days after surgery | 
| Mortality | 30 days mortality will be noted if death occurred within this period | Upto 30 days after surgery |