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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS50 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Oxygen Deficiency

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.

Time frame: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.

Secondary Outcomes

Tissue oximetry

Describing intraoperative variation of tissue oximetry expressed in percent.

Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.

Tissue oximetry during hyperthermic intraperitoneal chemotherapy

Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.

Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .

Emodinamic parameters (systolic, mean and diastolic pressures)

Describing mean values of intraoperative arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg

Time frame: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.

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

Time frame: A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy

Serum Creatinine level

Mean value of creatinine, daily assessed for the first 7 postoperative days, expressed in mg/dL

Time frame: From 1st to 7th postoperative days

Serum Blood urea nitrogen level

Mean value of Serum blood urea nitrogen, daily assessed for the first 7 postoperative days, expressed in mg/dL