NCT06475261

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Oxygen Deficiency
• Acute Kidney Injury
• Ovarian Carcinoma

Interventions

Type	Name	Description
DEVICE	Tissue Oximetry with ForeSight	Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer

Timeline

• Start date: 2024-07-27
• Primary completion: 2025-08-31
• Completion: 2025-09-30
• First posted: 2024-06-26
• Last updated: 2025-03-07

Locations

1 site across 1 country: Italy