NCT06103214

The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery

The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 Group(n=30), ANH Group(n=30) and AHH Group(n=30). Patients underwent standard preoperative preparation for cytoreductive surgery according to institutional standards.All 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.

Conditions

• Ovarian Neoplasm Epithelial

Interventions

Type	Name	Description
OTHER	acute normovolemic hemodilution (ANH)	Acute normovolemic hemodilution (ANH) is a medical procedure that involves removing a certain volume of blood from a patient before surgery and replacing it with a volume expander or blood substitute. The goal of ANH is to reduce the need for blood transfusions during or after surgery. During the ANH procedure, a patient's blood is typically withdrawn and replaced with a crystalloid or colloid solution. This dilutes the patient's blood, reducing the concentration of red blood cells. The withdrawn blood is then stored and can be reinfused back into the patient after the surgical procedure is completed.
OTHER	acute hypervolemic hemodilution (AHH)	The purpose of diluting the blood with fluids and removing some of the red blood cells is to decrease the viscosity of the blood. This can improve blood flow and oxygen delivery to tissues, especially in cases of decreased blood flow or oxygenation.

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-05-31
• Completion: 2023-01-31
• First posted: 2023-10-26
• Last updated: 2023-10-26