Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
NCT06475261 · Phase II · Rome, Italy
- Condition
- Kidney Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- DEVICE
- Intervention
- Tissue Oximetry with ForeSight
- Age
- 18 Years to 75 Years
- Gender
- Female
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Research institution
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Facility
- Policlinico "A. Gemelli" IRCCS
- Research center
- Policlinico "A. Gemelli" IRCCS
Summary
Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. However, there is no evidence in the existing scientific literature on the use of muscle tissue oximetry in patients undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy. The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.
Detailed description
Tissue oximetry obtained from peripheral muscle can be used to measure the state of kidney's tissue oxygenation. 50 Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy will be enrolled. The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage (according to the AKIN and KIDGO classification) in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer. Secondary objectives are: * describe the variation in muscle tissue oximetry and hemodynamic parameters (systolic, mean, diastolic blood pressure) during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy . * describe the variation in renal function values (blood urea nitrogen, creatinine) and serum electrolytes (sodium, potassium, chloremia, calcemia) in the post-operative period (from the first to the seventh postoperative day).
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
Primary outcomes
Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
Secondary outcomes
Tissue oximetry; Tissue oximetry during hyperthermic intraperitoneal chemotherapy; Emodinamic parameters (systolic, mean and diastolic pressures)