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Clinical Trials/NCT06398769
NCT06398769
Not yet recruiting
Not Applicable

Comparison of VCare and SecuFix Uterine Manipulator in Total Laparoscopic Hysterectomy

Dr. Lutfi Kirdar Kartal Training and Research Hospital0 sites10 target enrollmentStarted: May 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Enrollment
10
Primary Endpoint
operative time

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Device Feasibility
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Patients will be unaware that they will undergo an abdominal hysterectomy using VCare or SecuFix for their surgical procedure.

Data entry will utilize a coded system within a pre-designed SPSS spreadsheet. A research assistant, who will be independent of the intervention administration, will enter data for each patient using a designated code (1 or 2) that corresponded to the group assignment. All data will send to an independent statistician for blinded analysis.

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

operative time

Time Frame: Operation time was defined as the duration in minutes from the skin incision to detachment of the uterus during surgery.

Operation time was defined as the duration from the skin incision to detachment of the uterus.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Esra Keles

Assoc Prof, MD, PhD candidate

Dr. Lutfi Kirdar Kartal Training and Research Hospital

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