An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Condition(s) studied
Investigational drug(s) / intervention(s)
Hyperthermic intraperitoneal chemotherapy: Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively
Study summary
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.
Eligibility
Primary outcome measure(s)
- Changes in invasive blood pressure in perioperative period — From start of surgery upto 48 hours after surgery
Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner - Changes in body temperature in perioperative period — From start of surgery upto 48 hours after surgery
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 - Changes in cardiac output in perioperative period — From start of surgery upto 48 hours after surgery
Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner - Changes in arterial blood gas in perioperative period — From start of surgery upto 48 hours after surgery
Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tata Memorial Hospital | Mumbai | Maharashtra | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02754115 on ClinicalTrials.gov ↗ ← All trials in India