About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society Anesthesiologists (ASA) Classification 1-2
Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.
Disqualifiers
Age < 18 years
ASA > or = 3
Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy
Trial population
Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Tissue Oximetry with ForeSight
DeviceEvaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer
Treatment groups
Trial outcomes
Primary outcomes
Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
An intraoperative mean tissue oximetry value of 65% or less is considered to predict cellular damage. Postoperative renal injury is classified according to AKIN and KIDGO criteria.
Secondary outcomes
Tissue oximetry
Describing intraoperative variation of tissue oximetry expressed in percent.
Tissue oximetry during hyperthermic intraperitoneal chemotherapy
Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.
Emodinamic parameters (systolic, mean and diastolic pressures)
Describing mean values of intraoperative arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg
Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy
Describing mean values of arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg, during hyperthermic intraperitoneal chemotherapy
Sponsors and contacts
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