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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-27

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

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Oxygen Deficiency Acute Kidney Injury Ovarian Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Hemodynamics parameters with Hemosphere

Eligibility Criteria

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Inclusion Criteria

* American Society Anesthesiologists (ASA) Classification 1-2
* Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.