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VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy

R

Republic of Turkey Ministry of Health

Status

Not yet enrolling

Conditions

Perioperative Complications
Length of Hospital Stay
Operative Time

Treatments

Device: SecuFix UM
Device: VCare UM

Study type

Interventional

Funder types

Other

Identifiers

NCT06398769
uterinemanipulator-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

Female

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • aged 35-65 years
  • hysterectomy for benign gynecological indications

Exclusion criteria

  • history of urogynecologic procedures
  • suspected gynecological malignancy,
  • endometriosis,
  • pelvic inflammatory disease,
  • pelvic organ prolapse,
  • unavailibility of operative records

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups

SecuFix UM
Experimental group
Description:
SecuFix UM arm: patients undergoing total laparoscopic hysterectomy
Treatment:
Device: SecuFix UM
VCare UM
Active Comparator group
Description:
VCare UM arm: patients undergoing total laparoscopic hysterectomy
Treatment:
Device: VCare UM

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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