Actively Recruiting

Age: 18Years - 70Years
All Genders
ID02754115

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

Led by Tata Memorial Centre · Updated on 2024-11-21

400

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Peritoneal carcinomatosis often occurs in colorectal and digestive tract cancers. Researchers are auditing perioperative changes in patients undergoing cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC), focusing on the challenges and physiological changes during this complex treatment. This observational study aims to better understand the effects and management of these procedures in patients treated for cancers such as colorectal, gastric, ovarian, or peritoneal mesothelioma. The treatment involves CRS to remove visible metastatic disease in the abdomen and pelvis, along with HIPEC where heated chemotherapy is applied inside the abdomen for 90 minutes at 42ºC. This extensive procedure can lead to significant blood and fluid loss, as well as cardiovascular and metabolic changes before, during, and after surgery. The study collects perioperative data from patients receiving this combined treatment to monitor these effects. Participants will be monitored from the start of surgery up to 48 hours afterward to track changes in blood pressure, body temperature, cardiac output, and arterial blood gases. Secondary measures include length of stay in intensive care and mortality up to 30 days post-surgery. The study aims to document perioperative physiological alterations and related outcomes to improve coordinated care by the surgical and anesthetic teams.

CONDITIONS

Brief Title

An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 to 70 years
  • ASA Class I to III
  • Colorectal and gynecological oncology cases posted for CRS with HIPEC
Not Eligible

You will not qualify if you...

  • Age less than 18 and more than 70 years
  • ASA Class IV and above

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - From start of surgery up to 48 hours after surgery

Participants undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy and are monitored closely during the perioperative period.

Continuous monitoring during hospital stay

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are observed for recovery including length of stay in intensive care and survival for up to 30 days after surgery.

Approximately 1 to 2 follow-up visits

Trial Site Locations

Total: 1 location

1

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400012

Actively Recruiting

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Research Team

S

Sohan L Solanki, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

The Hemodynamic Management and Postoperative Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Observational Study.

Sohan Lal Solanki, Vandana Agarwal, Reshma P Ambulkar...

https://pubmed.ncbi.nlm.nih.gov/39760061