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Clinical Trials/NCT02754115
NCT02754115RecruitingNot Applicable

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

Tata Memorial Centre1 site in 1 country400 target enrollmentStarted: April 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
400
Locations
1
Primary Endpoint
Changes in body temperature in perioperative period

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age between 18 to 70 years
  • ASA Class I to III
  • Colorectal and gynecological oncology cases posted for CRS with HIPC.

Exclusion Criteria

  • Age less than 18 and more than 70 years
  • ASA Class IV and above

Outcomes

Primary Outcomes

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 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

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 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

Secondary Outcomes

  • Mortality(Upto 30 days after surgery)
  • Length of stay in intensive care unit(Upto 30 days after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sohan Lal Solanki

Assistant Professor, Department of Anesthesiology, Critical Care and Pain

Tata Memorial Centre

Study Sites (1)

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