NCT02754115 An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
| NCT ID | NCT02754115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2016-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2016-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sohan L solanki
PRINCIPAL INVESTIGATOR
Tata Memorial Centre
Frequently Asked Questions
Who can join the NCT02754115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02754115 currently recruiting?
Yes, NCT02754115 is actively recruiting participants. Contact the research team at me_sohans@yahoo.co.in for enrollment information.
Where is the NCT02754115 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT02754115 clinical trial?
NCT02754115 is sponsored by Tata Memorial Centre. The principal investigator is Sohan L solanki at Tata Memorial Centre. The trial plans to enroll 400 participants.
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