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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue oximetry | Describing intraoperative variation of tissue oximetry expressed in percent. | TWA value resulted by intraoperative values recorded every 20 minutes during surgery. |
| Tissue oximetry during hyperthermic intraperitoneal chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Catarci, MD | Contact | 0630153744 | stefano.catarci@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Catarci, MD | FPG IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico "A. Gemelli" IRCCS | Recruiting | Rome | Italy |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D058186 | Acute Kidney Injury |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.
| 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 | 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 | 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 | 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 | From 1st to 7th postoperative day |
| Serum sodium level | Mean values of Serum sodium, daily assessed for the first 7 postoperative days, expressed in mmol/L | From 1st to 7th postoperative day |
| Serum Potassium level | Mean values of Serum potassium, daily assessed for the first 7 postoperative days, expressed in mmol/L | From 1st to 7th postoperative day |
| Serum Chloride level | Mean values of Serum chloride, daily assessed for the first 7 postoperative days, expressed in mmol/L | From 1st to 7th postoperative day |
| Serum Calcium level | Mean values of Serum calcium, daily assessed for the first 7 postoperative days, expressed in mmol/L | From 1st to 7th postoperative day |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |