An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02754115
• Other study ID #: PN 1667
• Status: Recruiting
• Start date: April 2016
• Est. completion date: January 2027

Study information

• Verified date: August 2023
• Source: Tata Memorial Centre
• Contact: Sohan L Solanki, MD
• Phone: +919869253201
• Email: me_sohans[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Ovarian Cancer
• Peritoneal Disease
• Peritoneal Diseases

Intervention

Other:
• Hyperthermic intraperitoneal chemotherapy
Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Mortality	30 days mortality will be noted if death occurred within this period	Upto 30 days after surgery