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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tissue Oximetry with ForeSight

    Device

    Evaluation 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

1

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.
2

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 .
3

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.
4

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

Other outcomes

Sponsors and contacts

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