VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy

NCT06398769 | Not Yet Recruiting

• 1 other identifier: uterinemanipulator-1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Operative Time; Length of Hospital Stay; Perioperative Complications

Keywords

uterine manipulator; laparoscopy; Instruments; minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• operative time

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

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

Study Arms (2)

SecuFix UM

EXPERIMENTAL

SecuFix UM arm: patients undergoing total laparoscopic hysterectomy

Device: SecuFix UM

VCare UM

ACTIVE COMPARATOR

VCare UM arm: patients undergoing total laparoscopic hysterectomy

Device: VCare UM

Interventions

SecuFix UM DEVICE

All surgeries were performed using Secufix UM.

SecuFix UM

VCare UM DEVICE

All surgeries were performed using VCare UM.

VCare UM

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof, MD, PhD candidate

Model Details: prospective randomized trial

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share