Clinical trial NCT02754115: An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
Official title: A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Ovarian Cancer
Peritoneal Disease
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: American Society of Anesthesiologist class I, II and III patients

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.


Eligibility criteria: 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 outcomes:
measure: Changes in invasive blood pressure in perioperative period
timeFrame: From start of surgery upto 48 hours after surgery
measure: Changes in body temperature in perioperative period
timeFrame: From start of surgery upto 48 hours after surgery
measure: Changes in cardiac output in perioperative period
timeFrame: From start of surgery upto 48 hours after surgery
measure: Changes in arterial blood gas in perioperative period
timeFrame: From start of surgery upto 48 hours after surgery
Secondary outcomes:
measure: Length of stay in intensive care unit
timeFrame: Upto 30 days after surgery
measure: Mortality
timeFrame: Upto 30 days after surgery
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
Study officials:
affiliation: Tata Memorial Centre
name: Sohan L solanki
role: PRINCIPAL_INVESTIGATOR
References: