Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-26
Brief Title:
VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy
Sponsor:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Organization:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Study Overview
Official Title:
Comparison of VCare and SecuFix Uterine Manipulator in Total Laparoscopic Hysterectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Hysterectomy the most commonly performed gynecological operation can be carried out through various methods using a wide array of instruments and energy techniques Minimally invasive procedures such as robotic or laparoscopic approaches are linked to lower perioperative complications and quicker recovery when compared to abdominal hysterectomy Furthermore recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries Uterine manipulation plays a crucial role in laparoscopic hysterectomy by facilitating bladder dissection positioning the ureters and exposing the anterior and posterior vaginal fornices It also prevents pneumoperitoneum loss by closing off the vaginal space Despite these apparent benefits there is no existing report comparing different types of uterine manipulators Therefore the purpose of this study was to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy based on operative time length of hospital stay estimated blood loss perioperative complications and subjective performance
Detailed Description:
Introduction Hysterectomy is the most commonly performed gynecological operation and can be carried out through various methods using a wide array of instruments and energy techniques Although the methods have advantages and disadvantages over each other minimally invasive procedures are associated with less morbidity and perioperative recovery Recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries Uterine manipulation is crucial in laparoscopic hysterectomy as it facilitates bladder dissection positioning the ureters and exposing the anterior and posterior vaginal fornices It also maintains pneumoperitoneum Currently many uterine manipulators are available but the evidence for their efficacy and safety is still unclear The purpose of utilizing a uterine manipulator is to enhance surgical outcomes and reduce intraoperative complications particularly concerning the bladder and ureter It is important to visualize the anterior and posterior fornices and ensure maintenance of the pneumoperitoneum Therefore uterine manipulators play a crucial role in laparoscopic hysterectomy However none of the manipulators currently available possess all the characteristics of an ideal manipulator Therefore the investigators aimed to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy with regard to operative time length of hospital stay estimated blood loss and perioperative complications
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?:
False
Is an FDA AA801 Violation?:
None