An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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

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 Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Ovarian Cancer; Peritoneal Disease
• Intervention / Treatment: Other: Hyperthermic intraperitoneal chemotherapy

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Sohan L Solanki, MD; Phone Number: +919869253201; Email: me_sohans@yahoo.co.in

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Recruiting
      • Tata Memorial Hospital
      • Contact: Sohan L solanki, MD; Phone Number: 9869253201; Email: me_sohans@yahoo.co.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

American Society of Anesthesiologist class I, II and III patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in invasive blood pressure in perioperative period	Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner	From start of surgery upto 48 hours after surgery
Changes in body temperature in perioperative period	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	From start of surgery upto 48 hours after surgery
Changes in cardiac output in perioperative period	Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner	From start of surgery upto 48 hours after surgery
Changes in arterial blood gas in perioperative period	Arterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner	From start of surgery upto 48 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tata Memorial Centre
• Investigators: Principal Investigator: Sohan L solanki, Tata Memorial Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimated): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases
• Other Study ID Numbers: PN 1667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES