Measuring tissue oxygen levels during surgery for ovarian cancer
Official title: Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06475261 · Data updated 2026-11-12
This study is testing if low oxygen levels in muscle during surgery for ovarian cancer can lead to kidney problems afterward in women undergoing treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | July 27, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06475261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult female patients classified as ASA 1-2 who are undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy.
✕Probably not a fit
Patients under 18 years old or those with ASA classification of 3 or higher will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the correlation between muscle tissue oxygen levels and postoperative kidney damage in women undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy. It involves measuring tissue oximetry from peripheral muscle to assess oxygenation levels during surgery. The study will enroll 50 adult female patients classified as ASA 1-2 and will monitor various hemodynamic parameters and renal function values postoperatively. The aim is to determine if low oxygen levels during surgery are linked to acute kidney injury.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for kidney damage during surgery, potentially leading to improved surgical outcomes.
How similar studies have gone: While the use of tissue oximetry has been documented in other contexts, this specific application in ovarian cancer surgery is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society Anesthesiologists (ASA) Classification 1-2 * Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy. Exclusion Criteria: * Age \< 18 years * ASA \> or = 3 * Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy
Where it's running
-
Policlinico "A. Gemelli" IRCCS
Rome, Italy Recruiting
Study contacts
- Principal investigator: Stefano Catarci, MD — Fpg Irccs
- Study coordinator: Stefano Catarci, MD
- Email: stefano.catarci@policlinicogemelli.it
- Phone: 0630153744
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.