Skip to content

An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02754115
Enrollment
400
Registered
2016-04-28
Start date
2016-04-30
Completion date
2027-01-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Ovarian Cancer, Peritoneal Disease

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.

Interventions

OTHERHyperthermic intraperitoneal chemotherapy

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

Sponsors

Tata Memorial Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in invasive blood pressure in perioperative periodFrom start of surgery upto 48 hours after surgeryInvasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner
Changes in body temperature in perioperative periodFrom start of surgery upto 48 hours after surgeryBody 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 cardiac output in perioperative periodFrom start of surgery upto 48 hours after surgeryCardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
Changes in arterial blood gas in perioperative periodFrom start of surgery upto 48 hours after surgeryArterial blood gases will be measured in perioperative period and changes from baseline will be recorded in a graphical manner

Secondary

MeasureTime frameDescription
Length of stay in intensive care unitUpto 30 days after surgeryLength of stay will be measured in days from admission to discharge in intensive care unit
MortalityUpto 30 days after surgery30 days mortality will be noted if death occurred within this period

Countries

India

Contacts

Primary ContactSohan L Solanki, MD
me_sohans@yahoo.co.in+919869253201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026