Clinical Trial

An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Recruiting
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2016-04-25; most recent amendment 2024-11-18.
Status change: Not Yet Recruiting → Recruiting 2016-05-11
Trial Details
NCT Number NCT02754115
Lead Sponsor Tata Memorial Centre
Conditions Colorectal Cancer, Ovarian Cancer, Peritoneal Disease
Enrollment 400 participants
Start Date 2016-04
Primary Completion 2026-12 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-21