Measuring tissue oxygen levels during surgery for ovarian cancer
Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06475261 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old or those with ASA classification of 3 or higher will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.