Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Tissue Oximetrys Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Tissue Oximetrys Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy Prospective Observational Study With Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 kidneys 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
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
Detailed Description:
Tissue oximetry obtained from peripheral muscle can be used to measure the state of kidneys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None