An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Recruiting now
Conditions studied: Colorectal Cancer, Ovarian Cancer, Peritoneal Disease
In brief
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.
Key facts
- Study ID
- NCT02754115
- Run by
- Tata Memorial Centre
- People needed
- 400
- Starts
- 2016-04-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2024-11-21
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 to 70 years
- ASA Class I to III
- Colorectal and gynecological oncology cases posted for CRS with HIPC.
You may not qualify if…
- Age less than 18 and more than 70 years
- ASA Class IV and above
Where it is running
- Tata Memorial Hospital — Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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