An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

T

Tata Memorial Centre

Status

Enrolling

Conditions

Peritoneal Disease
Ovarian Cancer
Colorectal Cancer

Treatments

Other: Hyperthermic intraperitoneal chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT02754115
PN 1667

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Sohan L Solanki, MD

Data sourced from clinicaltrials.gov

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