Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103214
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-09-23
Brief Title:
The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery
Status:
COMPLETED
Status Verified Date:
2023-10
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:
Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH as the procedure is associated with moderately high blood loss As the technique has not yet been described in this setting investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period with the intent of proceeding to a randomized trial if results were favorable
Detailed Description:
Using a computer-generated random number table patients were randomized to three groups Control Groupn30 ANH Groupn30 and AHH Groupn30 Patients underwent standard preoperative preparation for cytoreductive surgery according to institutional standardsAll patients who underwent a standard anesthesia protocol and similar surgical procedures were considered for the analysis For this purpose investigators only included patients who underwent the following interventions radical hysterectomy bilateral adnexectomy one or more bowel resection peritonectomy pelvic lymphadenectomy and extended periaortic lymphadenectomy The patient would be ruled out of the experiment when the participant was accompanied with any kind of serious complications such as wakening delay and drug allergy
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