An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

NCT ID: NCT02754115

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2027-01-31

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.

Conditions

Colorectal Cancer; Ovarian Cancer; Peritoneal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Hyperthermic intraperitoneal chemotherapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Centre

OTHER

Sponsor Role: lead

Responsible Party

Sohan Lal Solanki

Assistant Professor, Department of Anesthesiology, Critical Care and Pain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sohan L solanki

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Centre

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Sohan L Solanki, MD

Role: CONTACT

me_sohans@yahoo.co.in

+919869253201

Facility Contacts

Sohan L solanki, MD

Role: primary

me_sohans@yahoo.co.in

9869253201

References

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.

Reference Type: DERIVED

PMID: 39760061 (View on PubMed)

Other Identifiers

PN 1667

Identifier Type: -

Identifier Source: org_study_id