Clinical Trial: An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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.


Detailed Summary:
Sponsor: Tata Memorial Centre

Current Primary Outcome:

  • Changes in invasive blood pressure in perioperative period [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of stay in intensive care unit [ Time Frame: Upto 30 days after surgery ]
    Length of stay will be measured in days from admission to discharge in intensive care unit
  • Mortality [ Time Frame: Upto 30 days after surgery ]
    30 days mortality will be noted if death occurred within this period


Original Secondary Outcome: Same as current

Information By: Tata Memorial Centre

Dates:
Date Received: March 29, 2016
Date Started: April 2016
Date Completion: May 2021
Last Updated: May 11, 2016
Last Verified: May 2016