An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Recruiting

• Conditions: Colorectal Cancer; Peritoneal Disease; Ovarian Cancer

• Registration Number: NCT02754115
• Lead Sponsor: Tata Memorial Centre

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-03-29
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
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 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, Maharashtra, India