VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Operative Time Length of Hospital Stay Perioperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized trial

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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SecuFix UM

SecuFix UM arm: patients undergoing total laparoscopic hysterectomy

Group Type EXPERIMENTAL

SecuFix UM

Intervention Type DEVICE

All surgeries were performed using Secufix UM.

VCare UM

VCare UM arm: patients undergoing total laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

VCare UM

Intervention Type DEVICE

All surgeries were performed using VCare UM.

Interventions

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SecuFix UM

All surgeries were performed using Secufix UM.

Intervention Type DEVICE

VCare UM

All surgeries were performed using VCare UM.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes