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Recruiting NCT02754115

An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

— Observational Colorectal Cancer Ovarian Cancer Peritoneal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperthermic intraperitoneal chemotherapy.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Ovarian Cancer, Peritoneal Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Changes in invasive blood pressure in perioperative period [Time frame: From start of surgery upto 48 hours after surgery]
  • Changes in body temperature in perioperative period [Time frame: From start of surgery upto 48 hours after surgery]
  • Changes in cardiac output in perioperative period [Time frame: From start of surgery upto 48 hours after surgery]
  • Changes in arterial blood gas in perioperative period [Time frame: From start of surgery upto 48 hours after surgery]
Secondary outcome measures (2)
  • Length of stay in intensive care unit [Time frame: Upto 30 days after surgery]
  • Mortality [Time frame: Upto 30 days after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

India · 1 center
  • Tata Memorial Hospital — Mumbai

Publications

  • Solanki SL, Agarwal V, Ambulkar RP, Joshi MP, Chawathey S, Rudrappa SP, Bhandare M, Saklani AP. The Hemodynamic Management and Postoperative Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Observational Study. Crit Care Res Pract. 2024 Dec 27;2024:8815211. doi: 10.1155/ccrp/8815211. eCollection 2024. PMID 39760061

Identifiers

NCT: NCT02754115 · PN 1667

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗