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Recruiting Observational

An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

NCT02754115 · tracked via the Priya Life Science India tracker
Phase
Observational
Started
2016-04
Last updated
2024-11-21

Condition(s) studied

Colorectal CancerOvarian CancerPeritoneal Disease

Investigational drug(s) / intervention(s)

Hyperthermic intraperitoneal chemotherapy

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 to 70 years 2. ASA Class I to III 3. Colorectal and gynecological oncology cases posted for CRS with HIPC. Exclusion Criteria: 1. Age less than 18 and more than 70 years 2. ASA Class IV and above

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)

FacilityCityRegionStatus
Tata Memorial Hospital Mumbai Maharashtra Recruiting
Official registry record

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